CONTENTS NEWS
LAB IN FOCUS
Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty
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QIAGEN CEO QUITS AMID GENETIC SEQUENCING U-TURN
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CLEVELAND DIAGNOSTICS RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION FOR NOVEL PROSTATE CANCER DIAGNOSTIC TEST
Editor Viveka Roychowdhury* BUREAUS Mumbai Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Prabhat Prakash, Tarannum Rana Delhi Prathiba Raju, Akanki Sharma Bengaluru Usha Sharma Design Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht
The Kolkata-based diagnostics chain believes that success is not only in terms of generating the highest revenue rather in being successful to achieve a permanent place in the hearts of thousands of its customers by offering the latest technologies and world class services in a most affordable and customer-friendly way | P-20
LEADER'S CORNER ON THE EDGE
Graphics Designer Gauri Deorukhkar Artists Rakesh Sharma
SURAKSHA DIAGNOSTICS: BETTING BIG ON AUTOMATION
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TIMEOUT
CO-DIAGNOSTICS EXPANDS VECTOR CONTROL MARKETING NATIONWIDE
Digital Team Viraj Mehta (Head of Internet)
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Photo Editor Sandeep Patil MARKETING Douglas Menezes, Sunil kumar Debnarayan Dutta Ajanta Sengupta E Mujahid PRODUCTION General Manager BR Tipnis Production Co-ordinator Dhananjay Nidre Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar
BALANCE OF MIND IMPROVES PRODUCTIVITY
TRADE AND TRENDS
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NEW TEST FOR THYROID CANCER COULD PREVENT UNNECESSARY SURGERY KEEPING INFANTS AT LOWER LEVEL UNITS AFTER BIRTH ASSOCIATED WITH HIGHER RISK OF DEATH: THE BMJ
P18: INTERVIEW SURESH VAZIRANI MD and CEO, Transasia Bio-Medicals
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CHANGING HEALTHCARE LANDSCAPE: THE ROLE OF DIGITAL TOOLS
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'HAEMATOLOGY AUTOMATION' MUST FOLLOW 'MANUAL TECHNIQUES' BUT WHEN? WHAT THE RESEARCH SAYS?
Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.
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EDITOR’S NOTE
Accreditation of diagnostic labs is vital but ...
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he diagnostics lab sector reflects both the highs and lows of India’s entrepreneurial spirit. There are close to 100,000 pathology and diagnostic labs in India. But only about 1000 are accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL). This is not very reassuring for patients in India as it means that they cannot always trust the lab results they receive. This puts a question mark on diagnosis and treatment outcomes, adding to the cost of healthcare borne by patients. Its been a decade since one of the first moves to set standards for diagnostic labs in India. In 2009-2010, the Central Government Health Scheme (CGHS) announced NABL accreditation as mandatory for empanelment of laboratories. NABL received 225 applications for accreditation of medical laboratories to ISO 15189 standards. But 80 per cent had to be shut as they could not meet the requirements of NABL accreditation. A decade later, a majority (80 per cent) of India’s diagnostic labs are small, 18 per cent medium and only two per cent are large sized national chains. As it is not feasible, especially for small laboratories performing basic testing, to directly aim for ISO 15189 accreditation, NABL decided to start small with an entry level voluntary scheme. Called the Quality Assurance Scheme (QAS) for Basic Composite (BC) Medical Laboratories (Entry Level), the first version of the procedure was released on February 4 this year, followed by two amendments, on June 11 and July 8. The amendments include components of assessment of technical competence to the criteria checklist. It is hoped that this will ensure quality of test results given by the laboratory and facilitate achieving ISO 15189 accreditation over a period of time. The entry Level QAS-BC certificate issued to laboratories, after a proficiency testing, is valid for two years. NABL will conduct an onsite assessment at least once during two years of cycle. Five to ten per cent of the labs complying with QAS-BC scheme will undergo unannounced onsite assessment. These laboratories may continue under this scheme by applying for renewal after the cycle of two years. After two cycles i.e. four years, NABL hopes they will achieve accreditation as per ISO 15189. Approved labs will be monitored by having to participate in an annual Proficiency Testing (PT) and submit these reports for review by NABL. Most labs of the national diagnostics chains are NABL accredited and in fact, are urging the government to make regulation more stringent. The hope is that NABL accreditation, followed by ISO 15189 will prove so unachievable for smaller regional, single lab entities that they would either shut down or sell out to the bigger names in the business. The diagnostics market is already in consolidation
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A balance will need to be struck between cost, choice and clinical standards
mode, with national chains buying up stand-alone labs in smaller cities. For instance, in October, Metropolis Healthcare's subsidiary Desai Metropolis Health Services acquired four labs in Surat, Gujarat: Doctor’s Clinical Laboratory, lyer Pathology Laboratory, Nagar Pathology Laboratory and Yash Clinical Laboratory. Around the same time, Dr Lal PathLabs’ subsidiary PathLabs Unifiers acquired 70 per cent take in Gujarat’s Amins Pathology Referral Laboratory. This was besides its earlier acquisition in June of 70 per cent stake in Central Lab, Indore to augment presence in Central India. Similarly, Neuberg Diagnostics is a consortium including Anand Diagnostic Laboratory (Bangalore), Supratech Micropath (Gujarat), Ehrlich Laboratory (Chennai), and across borders, Global Labs (South Africa) and Minerva Diagnostics (Dubai). As per Frost & Sullivan analysis, the diagnostics industry is projected to grow 1.3x to Rs 802.1 crore by FY20P. An asset light model as compared to hospitals has attracted entrepreneurs and venture capital funding as well. Consolidation is good as it brings in standardisation of results and often patients can access a larger menu of tests thanks to other partners in the chain. Companies benefit from economies of scale but are these benefits passed on the patients? Will consolidation create monopolies and ultimately add to healthcare costs for the patient? Will consolidation reduce choice for the patient? Thus, a balance will need to be struck between cost, choice and clinical standards. Like medicines, patients do not have the expertise to evaluate the quality of lab results nor interpret the results. They depend on doctors and hospitals to guide them. An accreditation number on a website or framed certificate from a government body like the NABL hung on a wall of a diagnostics lab is often the only tangible sign patients have while trying to decide which lab to trust. This choice is of course only available in metro cities. Patients in rural areas often do not have even this luxury of choice. As national chains vie for market share, their spend on branding campaigns, harping on their various accreditation, both national and global, is increasing. But will the regulator ensure that they actually do what they say they do? That they actually follow their own SOPs, that they are not only on paper but also practiced, in letter and spirit? Thus, NABL’s drive to create more awareness and get more labs to start on the accreditation journey is vital to make accurate diagnosis more accessible, available and affordable for all Indians.
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
NEWS
Qiagen CEO quits amid genetic sequencing U-turn In a surprise announcement, the maker of diagnostic kits for cancer and tuberculosis said it would stop developing its next-generation genome sequencing machines and instead collaborate with industry leader Illumina
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iagen’s longtime CEO Peer Schatz resigned after the German genetic testing company disclosed a reversal of its genome sequencing strategy and a slump in its Chinese business, sending its shares tumbling 20 per cent. Qiagen is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. In a surprise announcement, the maker of diagnostic kits for cancer and tuberculosis said it would stop developing its next-generation genome sequencing machines and instead collaborate with industry leader Illumina (ILMN.O). For the third quarter, Qiagen cut its forecast for sales growth, adjusted for currency swings, to about 3 per cent, down from a previous outlook of 4 per cent to five per cent, with its China business turning out significantly weaker than expected. Qiagen plans to take a pre-tax restructuring charge of about $260-$265 million, mainly to write down assets linked to the development of next-generation sequencing (NGS) instruments. It also cited an overhaul of its global manufacturing network and possible job cuts for the writedown.
IN RECENT YEARS THE COMPANY HAS DEVELOPED INTO A SMALLER NGS PLAYER, WHERE A WIDER RANGE OR ALL GENES ARE SEQUENCED
The company said Thierry Bernard, the head of the group’s molecular diagnostics business, would now take over as interim boss until a permanent CEO was found. “The fall from grace of Qiagen shares since June suggests that the market was already positioning for an unfavorable Q3, but the CEO’s departure will come as a surprise,” said Berenberg analyst Scott Bardo, adding the business nevertheless held the promise of attractive underlying growth. Qiagen’s core work includes making diagnostics kits that test for a single genetic mutation to help decide on treatment. But in recent years the company has developed into a smaller NGS player, where a wider range or all genes are sequenced. As part of a 15-year collaboration deal with NGS pioneer Illumina, Qiagen will rely on its genetic diagnostic products running on its new partner’s hardware. Schatz, who will become a special adviser to the supervisory board, had been with the company for 27 years. Since he started as finance chief in 1993, Qiagen has grown from $2 million in annual revenues to $1.5 billion in 2018. EDx Bureau
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NEWS
Cleveland Diagnostics receives FDA Breakthrough Device Designation for novel prostate cancer diagnostic test Through the Breakthrough Device Programme, Cleveland Diagnostics will work more closely and frequently with FDA to expedite its review of IsoPSA
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leveland Diagnostics, a clinical-stage company focussed on developing next-generation diagnostic tests for the early detection of cancers, has received FDA Breakthrough Device Designation for the IsoPSA Assay, a novel prostate cancer diagnostic test. Published studies from multicentre prospective clinical trials suggest that the non-invasive, blood-based IsoPSA assay has significant superior diagnostic accuracy when compared to traditional prostate-specific antigen (PSA) tests in detecting highgrade prostate cancer. FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Through the Breakthrough Device Programme, Cleveland Diagnostics will work more closely and frequently with FDA to expedite its review of IsoPSA. “We are grateful that FDA recognises the potential of IsoPSA, the first test in our pipeline of simple, affordable, and highly accurate cancer tests that focus on cancer-relevant changes to protein biomarkers in blood,” said Arnon Chait, CEO, Cleveland Diagnostics. “We look forward to working closely with FDA to expedite the appropriate approvals and get this important
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new test into the hands of physicians.” Cleveland Diagnostics has concluded two multicentre clinical trials in top US and international hospitals and clinics, led by Cleveland Clinic, in which the diagnostic accuracy of IsoPSA was compared to that of PSA, the current standard of care in prostate cancer, in men scheduled for
prostate biopsy. The results from those studies demonstrated that IsoPSA has superior diagnostic performance to traditional PSA in identifying which patients have highgrade disease. “The clinical utility of PSA is limited by the relatively poor diagnostic accuracy and predictive value of the test,” said Mark Stovsky, CMO, Cleveland
Diagnostics and Urologist at Cleveland Clinic. “Clinicians today are using an array of diagnostic tests and procedures to inform decisions about a patient’s prostate health and the risk of prostate cancer. We believe that IsoPSA has the potential to fill a major void in this space.” It is estimated that one in nine men will develop
prostate cancer in their lifetime. The results of previous studies have shown that IsoPSA could reduce unnecessary biopsies by at least 45 per cent, saving men from unneeded invasive, potentially risky and expensive procedures that can sometimes lead to serious and lasting side effects. EDX Bureau
Oxford Immunotec explores sale following takeover interest Oxford Immunotec is working with an investment bank to decide on its next steps after attracting acquisition interest
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xford Immunotec Global, a medical diagnostics company that develops tests to identify tuberculosis, is exploring strategic alternatives, including a potential sale, people familiar with the matter said. A deal for Oxford Immunotec would underscore the interest of bigger diagnostic companies in its socalled T-SPOT.TB test, which measures antigenspecific T cells indicative of a tuberculosis infection. About 23 per cent of the world’s population, or about 1.7 billion people, are infected with the bacterium that causes tuberculosis, according to the World Health Organisation. Oxford Immunotec is working with an investment bank to decide on its next steps after attracting acquisition interest, the sources said, cautioning that no deal was certain and asking not to be identified because the matter is confidential. Oxford Immunotec, which is headquartered near Oxford, England, and in Marlborough, Massachusetts, declined to comment. Oxford Immunotec sells its tuberculosis test kits and associated accessories to laboratories that perform the testing themselves. It also has a clinical testing laboratory in Britain where it performs the tests on samples sent in by clients. The company listed on the Nasdaq in 2013. Last year, it sold its laboratory services business to Quest Diagnostics (DGX.N) for gross proceeds of $170 million in cash.
The booster for those who boost the healthcare sector
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NEWS
Co-Diagnostics expands vector control marketing nationwide The products will be presented across the US at vector control conferences in six different states this month, in preparation for the 2020 mosquito season
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o-Diagnostics, a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced that their Vector Smart mosquito testing products will be presented across the US at vector control conferences in six different states this month, in preparation for the 2020 mosquito season. Mosquito abatement districts (MADs) are publiclyfunded departments at the city, county, and state level responsi-
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ble for controlling mosquito populations, and many of the 1,000 MADs throughout North America determine their annual budgets in Q4 of the preceding year. The conferences being attended by the company this month take place in Texas, Georgia, Idaho, Nebraska, Ohio, and Utah, each of which includes representatives from MADs in several of the surrounding states and Canadian provinces. Co-Diagnostics’ line of polymerase chain reaction (PCR)
multiplex assays for mosquito populations include a test for West Nile virus (WNV), St Louis encephalitis and western equine encephalitis (WEE); a test for Zika, dengue and chikungunya, which launched earlier this month and for which sales have already begun; and another multiplex that the Company says will be ready by the Spring 2020 mosquito season which includes eastern equine encephalitis (EEE) instead of WEE. WNV is now found in every state in the continental
US, and human cases of EEE, a mosquito-borne disease that kills roughly one-third of those infected and typically leaves survivors with 'mild to severe brain damage' according to the CDC, were found in seven states this year as well. Dwight Egan, CEO, Co-Diagnostics, remarked, “Attending conferences and presenting the quality and value of our vector control products directly to those in charge of determining budgets for mosquito abatement programmes is an impor-
tant step in our go-to-market strategy for this vertical. Likewise, finding new methods of identifying pathogens in mosquito populations is critical for MADs to improve their own efficiency in preventing the transmission of diseases to humans and livestock. With some of the only tests of their kind being offered to this market, we believe that the role Co-Diagnostics products play in these efforts will continue to grow.� Edx Bureau
New test for thyroid cancer could prevent unnecessary surgery The new metabolic thyroid test shows promise for preventing thousands of unnecessary thyroid removals each year
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esearchers at The University of Texas at Austin and Baylor College of Medicine have developed a new preoperative test for thyroid cancer that is faster and about two-thirds more accurate than the diagnostic tests doctors use today. Although more validation will be necessary before it can be used clinically, the new metabolic thyroid test shows promise for preventing thousands of unnecessary thyroid removals each year, such as the partial removal UT Austin grad student Amanda Helms had due to an inconclusive test. The results appeared in the journal Proceedings of the National Academy of Sciences. "If we could prevent people from having surgery they don't need and enable them to have a more precise diagnosis, we can improve treatment for patients and lower costs for the health care system," Livia S Eberlin, assistant professor of chemistry and diagnostic medicine at The University of Texas at Austin and co-principal investigator, said in a press release. Each year in the US, about 52,000 new cases of thyroid cancer are diagnosed. Unfortunately, the test used for diagnosis, called fine needle aspiration (FNA), is inconclusive about one out of every five times. When a pathologist is unable to confirm the presence of cancer, the patient may receive a fol-
low-up genetic test that itself can produce false positive results. Given the uncertainties, doctors often recommend removing part or all of the thyroid—the gland in the neck producing hormones that control the body's metabolic rate, as well as heart and digestive function, muscle control, brain development, mood and bone maintenance.
Thousands of patients each year have the surgery only to later learn it was unnecessary. Using a technology called mass spectrometry imaging, the new metabolic thyroid test identifies metabolites produced by cancerous cells that act as a kind of diagnostic fingerprint. The researchers worked on identifying these diagnostic metabolic
fingerprints for over two years using 178 patient tissues before starting a pilot clinical study. During the clinical study, 68 new patients were tested, nearly a third of whom had received inconclusive FNA results. The new metabolic thyroid test returned a false positive only about 1 time in 10 and could have prevented 17 patients in the study from undergoing unnecessary
surgeries. The team is now preparing to start a two-year validation study on FNAs from about a thousand new patients collected in the US, Brazil, and Australia. If the results hold up, they hope the technology will be translated to the clinic as a routine diagnostic tool. Source: Diagnostics World News
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NEWS
QIAGEN,Illumina partner to deliver sequencing-based IVD tests The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) system
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llumina and QIAGEN announced a 15-year partnership intended to broaden the availability and use of NGSbased in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management. The agreement grants QIAGEN non-exclusive rights to develop and globally commercialise IVD kits to be used together with Illumina's MiSeq Dx and NextSeq 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) systems. Both partners are also explor-
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ing opportunities for QIAGEN to develop and market companion diagnostics based on Illumina's TruSight Oncology (TSO) assays that enable comprehensive genomic profiling of tumor samples in immunotherapy. Illumina and QIAGEN will cooperate to commercialise a menu of clinically validated workflows that combine QIAGEN’s proprietary content and bioinformatics solutions. The partnership will initially focus on commercialising oncology IVD kits to support patient management and may expand in the future to include addi-
tional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases. "We are committed to expanding the range of clinical use cases addressed by genomic sequencing by enabling partners to deliver IVD tests and companion diagnostics on Illumina's Dx instruments," said Francis deSouza, CEO, Illumina. "Our partnership with QIAGEN will complement Illumina's TSO 500 family with additional testing menu options, accelerating NGS adoption in oncology patient man-
agement." "Bringing together our highly complementary capabilities marks an important milestone to advance the use of NGS technologies in clinical decision-making and our shared vision of using this powerful technology to improve the outcomes for patients worldwide," said Peer M Schatz, CEO, QIAGEN. “We at QIAGEN are pleased with this ground-breaking partnership and this first step in what we hope to be in a long and productive relationship that capitalises on combining our unique strengths. This
partnership becomes a key cornerstone of our NGS strategy, which continues to include our universal solutions for use with any sequencer as well as the GeneReader NGS System for use primarily with smaller, targeted gene panels. Through this partnership, we look forward to creating significant benefits for customers and for both parties, as well as to allowing QIAGEN to maximise our opportunities as a company creating value by offering sample-to-insight solutions." Source: Diagnostics World News s
Keeping infants at lower level units after birth associated with higher risk of death: The BMJ Neonatal services should ensure extremely preterm infants are born in tertiary care setting
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ransferring extremely premature babies from a lower (‘non-tertiary’) level neonatal care unit to a higher (‘tertiary’) level unit in the first 48 hours after birth is associated with an increased risk of severe brain injury, finds a study published by The BMJ. Keeping these infants at lower level units after birth is also associated with a higher risk of death, compared with birth in a tertiary facility. The findings are based on more than 17,000 births in England between 2008 and 2015, and suggest that neonatal services should be designed to ensure, whenever possible, that extremely preterm infants are born in a tertiary care setting. About one in 20 premature infants in high income countries are born extremely prematurely (at less than 28 weeks of pregnancy) and are at high risk of death, severe illness and long term disability. Studies from the 1980s found that transporting preterm infants from non-tertiary to tertiary care shortly after birth (known as ‘early postnatal transfer’) was linked to worse outcomes than preterm infants born in a tertiary setting. But results from recent studies have been inconclusive, and care for the most premature babies before and after birth has changed considerably since many of these studies were done. In England, early postnatal transfer continues to increase since neonatal care was reorganised in 2007, so it’s important to understand any effects associated with this.
To explore this further, researchers based in Finland and the UK analysed data for 17,577 extremely premature infants (born at less than 28 gestational weeks) in NHS hospitals in England between 2008 and 2015. Infants were grouped based on birth hospital and transfer within 48 hours. Factors that could have influenced the results, like gestational age and whether antenatal steroids were given, were also taken into account by forming matched groups of babies. Compared with controls (tertiary birth; not transferred), infants born in a nontertiary hospital and transferred to a tertiary hospital had no significant difference in risk of death before discharge but higher risk of severe brain in-
jury and lower chance of survival without severe brain injury. Infants born in a non-tertiary hospital and not transferred had higher risk of death but no difference in risk of severe brain injury or survival without severe brain injury, compared with controls. No differences in outcomes were found for infants transferred between tertiary hospitals (for non-medical reasons, such as insufficient capacity) and controls. All these results were largely unchanged after further sensitivity analyses, suggesting that the findings withstand scrutiny. This is an observational study, and as such, can’t establish cause, and the authors cannot rule out the possibility that
some of the outcomes may have been due to other unmeasured (confounding) factors. Nevertheless, they say this is one of the largest and most robust studies to focus on major outcomes among the highest risk infants in the context of modern neonatal care, and the results are in line with previous work in this field. As such, they conclude: “Extremely preterm birth in a nontertiary setting is associated with a higher risk of death and lower survival without severe brain injury compared with infants born in a tertiary neonatal setting.” They also recommend perinatal health services “promote pathways that facilitate delivery of extremely preterm infants in tertiary hospitals in preference to postnatal transfer.”
This view is supported by US researchers in a linked editorial, who say transfer before not after birth is the best approach for women at risk of preterm labour. Professor Colm Travers from the University of Alabama at Birmingham and colleagues point out that antenatal transfer is well established in some US states, Australia and Scandinavia, where up to 95 per cent of at risk infants are transferred before birth. “Improved regionalisation of perinatal care, prioritising early and clear transfer pathways for women with threatened preterm labour should increase survival and reduce major lifelong morbidities among extremely preterm infants,” they conclude. Edx Bureau
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COVER STORY
The National Essential Diagnostics List (NEDL) is a much-needed step towards standardisation of diagnostics in India. However, its true success will depend on its rational implementation, focus on quality, partnerships with private sector and the right investment in human resource, and supply chain By Raelene Kambli
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COVER STORY
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ccess to quality diagnostics is a key component to universal health coverage (UHC). While India has been focussing on increasing access to healthcare services across the country, many villages and rural lands still remain deprived of basic health and diagnostics needs. Disease management for a long time has largely relied on empirical therapies and syndromic management. And this clearly reflects the lack of access to quality diagnostics services. A study conducted by The Lancet, in its October 2018 issue, titled Availability of Essential Diagnostics in Primary Care in India indicated major gaps in availability of essential tests. The study examined three districts in three states of India, in north, south, central zones: Tumkur, Karnataka, 13 in Fatehpur, Uttar Pradesh, six in Wardha, Maharashtra, between December 13, 2017 to March 22, 2018. The study found gaps that can limit the ability of health workers to manage common diseases and the ability of the health systems to respond to threats such as outbreaks or antimicrobial resistance. This poses a huge challenge to tackle problems such as antimicrobial resistance, epidemics and non-communicable diseases (NCD). Nevertheless in July this year, India took the unprecedented step of releasing its first National Essential Diagnostics List (NEDL) based on the WHO essential in vitro diagnostics (IVD) list (EDL). The NEDL has been compiled by the ICMR with a vision to ensure availability of good quality and affordable diagnostics services across India.
Key factors of the NEDL According to ICMR, the process of compiling the NEDL was accomplished through a series of consultation meetings with the first meeting being organised in March 2018. Consultations with relevant stakeholders such as national programme managers, micro-
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SANJAYARORA
ZOYABRAR
Managing Director, Suburban Diagnostics
CEO, Core Diagnostics
Price control may become an outcome in future provided everyone operates on a level (standardised) playing field
biologists, pathologists, clinicians, health administrators and NGO/association representatives were organised subsequently to arrive at a list that is realistic and yet progressive. Based on expert suggestions, the NEDL provides a minimum set of tests that should be made available for patients. The NEDL focusses on 105 general laboratory tests, listed for detection and diagnosis of a broad range of common conditions and 30 disease specific tests designed for diagnosis and monitoring of diseases
such as HIV, hepatitis A, B, C, D and E, tuberculosis, dengue, malaria and diseases of endemic areas like scrub typhus, Japanese encephalitis, filariasis etc. The list also encompasses 24 radiology tests such as XRay, MRI, USG etc. The list enumerates tests which should be available at – village level, sub-centre/Heath and Wellness Centres (HWs), Primary Health Centres (PHC)/HWs, Community Health Centres (CHC), Sub-District Hospital (SDH), and District Hospital (DH). In the absence of availability of lab
The government should create mechanisms to check and control quality to a more significant degree than it is done today
infrastructure or resources and to minimise the patient movement between providers, a ‘hub and spoke model’ has been suggested. This will ensure availability of the required number of tests at different levels of facilities in a cost-efficient way. The list also encompasses tests relevant for new programmes such as Health and Wellness Centres (HWCs) under Pradhan Mantri Jan Arogya Yojana. In addition to tests, corresponding IVD products have also been recommended, as per ICMR sources.
Moreover, ICMR sources informed that the list also builds upon the Free Diagnostics Service Initiative which is crucial for the implementation of this plan. As experts point out that the impact of NEDL depends on the access to the diagnostic facilities enlisted. Hence, it is a must to integrate it with the revised Indian Public Health Standards (IPHS), the Health and Wellness Centres as well as the central government’s free diagnostic service and universal health coverage initiatives under the Ayushman Bharat
umbrella. Such an integration would not only be crucial for ensuring access, but would also go a long way in making the services affordable for all classes of society and in all parts of the country. For this reason, ICMR also suggests the human resource and equipment requirement proposed under the revised Indian Public Health Standards (IPHS). (Checkout the criteria for inclusion of test and key principals outlining the scope of the NEDL. Box 1 and 2). Also, the ICMR has drawn out specific enablers that can be beneficial for the successful implementation of NEDL. (Read on: Key enablers to pay the way for effective implementation. Box 3)
An opportunity or setback According to ICMR, NEDL provides a perfect opportunity for healthcare providers and the government to expand existing diagnostics services. ICMR also informs that NEDL will be instrumental just as the Essential Medicine List (EML) to bring in price control in diagnostics. Now, the industry seems to have mixed emotions with regard to this stance. While most players believe that the NEDL can standardise access to quality diagnostics in the country, yet its ramifications and lasting impact cannot be judged at the moment. Just as ICMR suggests, Dr Sushil Shah, MD, Metropolis Healthcare, foresees opportunities to expand services and partner with the government. He says, “India has become the first country in the world to compile an Essential Diagnostics List that will help the government to facilitate diagnostic needs in the remotest part of the country. A lot of inputs have come from the first edition of essential diagnostics list released by WHO last year. The list released by ICMR is customised to the needs of the country and its population as well. This is set to be beneficial to large established players like Metropolis as we have the strength to deliver in any cor-
DR ARUN DANG
DR PRASHANTKUMAR DASH
Associate Lab Director, Dr Dangs Lab
Director-Medical Services at Medlife.com
As the test costs are going to come down significantly the margins for providers will definitely be slashed
ner of the country. With effective public private partnerships (PPP) and with government taking the role of a facilitator, it is possible for the highest healthcare quality services to be delivered to every single citizen of this country.” “NEDL implementation would lead to an improvement in healthcare delivery based on proper diagnosis and better patient outcomes. It would help in making public health facilities more efficient and is also likely to bring down the out-of-pocket expenditure burden which has
so far been a major detriment in mass access to quality healthcare. Further, it is expected to result in better detection and calculation of the disease burden in the country, the trends, causes and various other aspects related to outbreaks and proliferation of health conditions in India. The move will also help address the critical gap in the standardisation of medical equipment and in-vitro diagnostic devices in India that has been in place due to lack of regulatory guidelines. One of the main aims of the NEDL is to
NEDL implementation would lead to an improvement in healthcare delivery based on proper diagnosis and better patient outcomes
create a guideline for the government to finalise the necessary diagnostic services for rural and far-flung areas in the country. Thus, it will be instrumental in providing access to affordable and quality diagnostic services to people all over the country, even in the remotest areas,” shares Dr Prashant Kumar Dash, Director-Medical Services, Medlife.com. Likewise, technology and equipment provider, Dr Suresh Vazirani, MD, Transasia BioMedicals also sees this an op-
portunity to reach out to those providers who aim to tap rural markets. He says, “NEDL is a good move to increase access to diagnostics. This also means that it will open new avenues to people trying to venture into rural areas and this will bring us more business too. But its right kind of implementation will be crucial.” Sharing a contrarian view, Dr Arun Dang, Associate Lab Director, Dr Dangs Lab, indicates that NEDL would in all probability lead to regularisation/capping of certain test
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COVER STORY costs that can be charged to the patients. This will also improve the much-needed accessibility to diagnostics but can negatively impact quality of services. “Although NEDL is an essential step to achieve universal healthcare, the snow-ball effect of capping diagnostics by the government would have a definite negative effect in terms of quality of testing and lab reports. On one hand it is essential for a large part of India in tier 2, 3 cities and villages where the affordability of the patient is a prime concern but in metro cities, tests at lower costs would definitely mean substandard equipment, manpower and lower levels of care,” he asserts. He further gives a simple example of a peripheral smear or a stool routine being microscopically examined and reported by a lab technician vs a DM hematopathology/ MD microbiology and said that it would have a huge impact in quality of the report and also the costs involved. Dr Sanjay Arora, MD, Suburban Diagnostics, adds, “Getting the policy executed at the grass root level will see a hugely positive impact on the health outcomes. An additional aspect that will be important will be the presence of well trained manpower — skilling could be a big challenge but also an opportunity to make this process more inclusive.” So as experts continue to examine its impact, there are some developments which will be certain after the actual implementation of NEDL.
Standardisation of tests India’s diagnostics industry has been a very fragmented market for a very long time. The sector lacked standardisation and therefore, timely and reliable diagnosis in many areas still remain a huge concern. Currently, accreditation with the National Accreditation Board for Testing and Calibration Laboratories (NABL) under the Quality Council of India (QCI) is optional and not mandatory. This has led to disparity in diagnos-
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BOX 1: ICMR CRITERIA FOR INCLUSION OFTESTS IN THE EDL ◗ ◗ ◗ ◗
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Conditions with high disease burden/high public health relevance where diagnostics have a clear impact on the diagnosis and management of a disease: Diseases with existing national programmes for diagnosis and management – maternal health complications, HIV, tuberculosis, malaria etc. For priority conditions with weaker support programmes: NPCDCS (diabetes, hypertension, cancers, chronic kidney disease etc.) Tests that enable safe and rational use of EML medicines – For instance in case of HIV/AIDS diagnosing the condition for which the medicine is indicated (rapid card, ELISA, etc.), monitoring for medication efficacy (CD4 count, HIV RNA load assays), and monitoring for medication toxicity (liver function tests). Conditions prone to outbreaks/epidemics (dengue) Tests encompassing care pathways of diseases/conditions. Tests which are not mainstay of diagnosis but are critical supporting tests such as complete blood count (CBC) and C-reactive protein (CRP).
BOX 2: KEY PRINCIPLES BY ICMR OUTLINING THE SCOPE OFTHE NEDL ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗
National EDL should be strategic, realistic and address the key demands of our country. Ability to deliver at multiple levels of healthcare, with a focus on primary health care, is a very important criterion for the national EDL. The list should have tests for both communicable and non-communicable diseases (NCDs), complimenting the national vertical health programmes. NEDL should be small, simple, robust, relevant and affordable to society. It should provide guidance on logistics and infrastructure, maintaining quality and supply chain. There is a need to build capacities of service providers in guiding patients which facilities offer what diagnostics tests, collection of samples at spokes and transport of samples to hubs. National EDL should ensure minimal movement of patient across facilities and providers. An innovative research in diagnostics related to our priority healthcare conditions was emphasised. Assay formats need to be discussed for cost-effectiveness considerations. Innovations are needed to bridge gap between rapid test and central laboratory tests. The necessity of point-of-care tests for common pathogens was emphasised. Inclusion of culture facilities in the list specifically for quality of healthcare and antimicrobial resistance was highly recommended. There is a need to ensure quality of products and tests for diagnosis – a well defined in-house validation and evaluation criteria are important.
tic approach adopted by various public health institutions and healthcare providers in different parts of the country. Additionally, lack of standards also gives rise to differential pricing which can considerably impact affordability if done irrationally. Hence, industry people believe that NEDL must focus on standardisation that reduces disputes, increase collaborations and improve health outcomes. “Having a standardised list is always helpful as it creates transparency, awareness and ensures that comparable services are provided to the patients
no matter where they go. The government should focus its energies on standardising not only that which is offered but also how it is offered. The government should create mechanisms to check and control quality to a more significant degree than it is done today,” suggests Zoya Brar, CEO, Core Diagnostics.
Rationalisation of prices While quality is one aspect of standardisation, appropriate pricing is another focal point of this list. NEDL promises to bring rationalisation of pricing
which can be beneficial to patients but can shrink profit margins of diagnostics providers and diagnostics kit manufacturers. “Considering that only 1 out of every 5 persons in India has ever opted to give their blood for testing, post implementation of NEDL and capping of tests this percentage is bound to increase. But as the test costs are going to come down significantly, the margins for providers will definitely be slashed,” ascertains Dr Dang. In the same light, Brar says that there would be an adverse downstream effect for patients
and providers both. She says, “NEDL would impact the margins of the pathology labs and diagnostic kit providers. More than margins, the bigger problem is that it will affect the consumer in the long run in a negative way. The companies will find ways to keep their margins intact by working around the quality parameters and it would be the customer at the end who bears the brunt of it.” Having said that, Dr Arora and Dr Dash believe that at present the ICMR is only focussing on standardisation in terms of quality and price control may not be the current goal. “I don’t see it making any adverse impact on the margins of pathology labs or diagnostic kits/devices providers. Yes, there would be standardisation which in certain cases might curtail margins for those charging haphazardly for diagnostic services. At the same time, by clearly outlining the processes to follow, it would also ensure that pathology labs, diagnostic services providers get to play a more active and inclusive role in providing quality healthcare to the public. Hence, I see it as an initiative which will make a positive impact on the public as well as the providers,” feels Dr Dash. Explaining further, Dr Arora spells out, “At this point, the purpose appears more of playing a regulatory role rather than one of price control. Standardisation of services is very important. This should allow only those service providers to operate that confirm to the basics set forth in the policy. Price control may become an outcome in future provided everyone operates on a level (standardised) playing field. At this time, price or margins should not get affected as the intent is more of standardisation and regulations to bring a basic level of acceptance to service and quality outcomes.” Well as the impact of NEDL standardisation in terms of price is yet to be established, another area that the industry contemplates is the involve-
ment of the states in its implementation. How important is the role of state governments in adopting NEDL and should the NEDL be implemented in phased manner within the state? This is crucial a question to be answered.
Increased role of state governments Healthcare has always been a state’s subject in India; therefore, the role of the state governments in its implementation will increase. Most industry people believe that a phase-wise implementation will be a good strategy to adopt. This can also help the states and the central government rectify mistakes. “Since this is a massive task being done for the first time, working towards optimum implementation and monitoring will be critical. Addressing the top of the tier which manages the largest population base and then working down the pyramid will allow both time and development of operational band-
BOX 3: KEY ENABLERS TO PAVE THE WAY FOR EFFECTIVE IMPLEMENTATION OF NEDL IN STATES ◗ ◗ ◗ ◗ ◗ ◗ ◗
High political and administrative commitment and leadership and adequate budgetary allocations. Integration with existing diagnostics initiatives and national health programmes, wherever necessary. Provision of requisite equipment/technology, human resources, procurement and supply chain. Evidence-based and rational prescription of tests. Quality assurance and strengthening of laboratory capacity across the health system for diagnostic services. Robust monitoring mechanisms. Adequate Information Education Communication (IEC) for awareness generation about availability of tests
width, necessary for successful implementation,” says Dr Arora. Getting the buy-in of local governments and local administration will be very important for the seamless and effective adoption of NEDL. The government can put a policy in place but ensuring that it is implemented along with the necessary infrastructure and systems, takes time and effort. State-level au-
thorities are required to ensure that NEDL is efficiently regulated and widely available. A colossal initiative, such as NEDL, would require regulation and coordination at both national and state-level,” adds Brar.
Good governance and investment need Furthermore, implementation will need to be backed by a
strong monitoring system. If there is very little or no evaluation and monitoring done, there is certainty of a huge failure. Therefore, a robust monitoring system is crucial and only then can the NEDL become the standard for benchmarking access. A white paper in Dr Sulaiman Al Habib Medical Journal and written by Dr Madhukar Pai, Prof, McGill International TB
Centre, McGill University, Montreal, Canada recently reviewed India’s draft NEDL. The report states that for a successful implementation of the NEDL, India will have to invest in strengthening public laboratories, contract private laboratories as required and make sure quality-assured testing services are freely available at all facilities. To address the weak laboratory capacity, four key barriers must be tackled: insufficient human resources or workforce capacity, inadequate education and training, inadequate infrastructure, insufficient quality, standards, and accreditation. Apart from this, a strong supply chain system will also be crucial. In the future, there is immense scope for NEDL to be a key in streamlining diagnostics supply chain in the country. NEDL also has the potential to be this great source of healthcare data that reflects the nation’s healthcare needs and disease burden. raelene.kambli@expressindia.com
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EXPRESS DIAGNOSTICS
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October 2019
LEADER'S CORNER I N T E R V I E W
Make in India holds the key to ensuring affordable diagnostic services India's diagnostics business scenario is changing tremendously. This change is driven by government intervention, digital transformations and increased business collaborations. In an freewheeling chat, Suresh Vazirani, MD and CEO, Transasia Bio-Medicals shares his perspective on the ever-changing business environment in Indian diagnostics with Raelene Kambli How do you see the Indian diagnostic sector shaping? Diagnostics as we all know is at the core of any medical treatment. The industry is expected to steadily grow at a CAGR of 15-16 per cent accounting to approximately $12.3 bn in 2020. The pathology segment is expected to contribute approximately 58 per cent to the total market, by revenue. If we consider the medical device market as a whole, India ranks 4th largest in Asia and among the top 20 globally. So you see, the medical device industry is on a growth trajectory. With regards to manufacturing, India has about 750-800 medical device manufacturers in the country, with an average turnover of Rs 450-500 million. Over the years, the industry has seen a transformational shift. Manufacturers and service providers are adopting automation and digital technologies, in order to serve their customers better. In fact, there is a growing trend in the use of digitisation and Artificial Intelligence in clinical labs whereby manufacturers are providing
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instruments with remote services for seamless operations. On the other hand, service providers are adopting the use of web-based platforms for electronic records. Secondly, there is a rising focus on preventive healthcare, as a result of high literacy levels and growing awareness. An increasing number of citizens are opting for proactive health check-ups with a comprehensive number of tests. This is further driven by customised packages offered by diagnostic chain labs that include improvement in collection logistics and affordability of testing. Another interesting trend is the emphasis on quality accreditations. It is good to see how the industry has woken up to quality compliance in manufacturing. Likewise, accreditation of laboratories ensures standardised services. Having said that, access to affordable diagnostics still remains the pain point of 70 per cent of our population, who have never had their blood tested. Providing cost-effective solutions is still a big challenge and as a country, we are still dependent on imported med-
ical devices. I reiterate that ‘Make in India’ holds the key to ensuring that affordable diagnostic services reach even the remotest areas. What is your opinion on the fragmented nature of diagnostics business in India? What about the increased number of illegal labs? A known fact is that the Indian medical device manufacturing sector is fragmented, both in its scale and geography. The various device manufacturing clusters in the country, along with medical device parks and medtech parks in the vicinity of these clusters, have the potential to create a large ecosystem of manufacturers, suppliers and developers. As a manufacturer we are implementing a niche differentiation strategy by focussing on customisation of products, commitment to after-sales services and quality. The fragmented nature of diagnostics, has led to the mushrooming of a large number of small labs, especially in remote areas. Moreover, setting up a pathology laboratory doesn’t require a skilled pathologist, as licenses can be easily obtained. Unfortunately, the number of diagnostic labs outnumber certified pathologists in the country. In such a scenario, misdiagnosis is not uncommon and most of the medical errors are triggered due to lack of skills and proper training. As a direct result of this skill gap, most laboratories are functioning illegally and are the ones responsible for the misdiagnosis and wrong treatment. Another important point to note is that less than five per cent of the laboratories in India are authorised by the National Accreditation Board for Testing and Calibration Laboratories (NABL), which is a very insignificant percentage of the total percentage of labs in India. Most labs rely on their internal processes to monitor quality. Only having a pathologist associated with the lab will not ensure reliable re-
The Government needs to devise stringent policies to prohibit path labs managed by unqualified professionals and noncalibrated or non-validated equipment sults. The Government needs to devise stringent policies to prohibit path labs managed by unqualified professionals and non-calibrated or non-validated equipment. What opportunities should diagnostic companies tap in the digital era? Internet of Things (IoT) has brought in a new wave of digital transformation. IoT refers to the network of devices embedded with software, sensors and connectivity that enables them to collect and exchange data. IoT offers a host of solutions for a win-win scenario for both the lab and the manufacturer. With an increasing focus on offering value-added services, manufacturers can now adopt IoT to resolve problems faster and effectively. Healthcare organisations are moving more towards cloud-based IT infrastructure, to better automate processes. In fact, IoT enabled medical devices can now be remotely monitored to predict possible problems and proactively resolve them thereby improving the uptime. IoT is most critical to the medical device industry as a precursor to enhanced patient care. The entire ecosystem caregivers, patients, and manufacturers, is experiencing a new level of engagement; that arises from the need to increase operational efficiency (through predictive maintenance and remote access), to enhance patient outcomes (through predictive healthcare). Transasia has integrated
IoT sensors to its fully automated systems. With its remote diagnosis technology, Transasia is able to provide an altogether different level of service to its customers and partner with them in improving lab efficiencies and benefitting the patients at large. What are the core values that diagnostic companies need to imbibe in order to build sustainable business models? Build you business model on quality. Strive for excellence and continue innovating your strategies, products and services. It is important to have a customer-centric approach for long-term business relations. What are the values that Transasia follows and how it contributed to the company's success? We believe in honest business. We believe in giving the customer their due- in terms of quality and value of products and the after-sales services that we provide. We also believe in paying taxes on time. Transasia Bio-Medicals recently recieved the ZED Diamond Quality rating. What is its significance? And how important is this rating to medical device manufacturers? The ZED Quality Certification is an initiative by the Government to encourage ‘Make in India’ and export of Indian products, through manufacturing practices, aligned towards providing products aimed at Zero Defect (for customers) and
Zero Effect (on the environment). The initiative is meant to raise quality levels in the manufacturing sector and is seen as the cornerstone of the Make in India programme. The diagnostic sector in India, is still highly dependent on imports of medical devices. Manufacturing our medical devices indigenously holds the key to meet India’s need for quality, accessible and affordable diagnostic services. The ZED certification further puts the spotlight on quality compliance for Indian device manufacturers. A pathology laboratory can be assured of standardised products and services from a ZED qualified manufacturer thereby ensuring standardised test results for the patients. What does this achievement mean to Transasia? For over four decades Transasia has been at the forefront of ensuring equitable diagnostic solutions across the length and breadth of the country. Early on, we recognised the huge gap in the demand and supply of the medical devices in the country and started manufacturing in India in the 1990s. Our focus has always been on quality, affordability and accessibility. Last year, Transasia became the first IVD Company in India to receive ICMED 13485 certification, the country’s first indigenous quality assurance system for India manufactured medical devices. And this year, Transasia has become the first IVD Company in India to be awarded ZED Diamond Qual-
ity rating. This milestone is a testimony that we employ GMP, Kaizen, Lean and other innovative processes to develop technologically advanced products that are also environmentally sustainable. It gives the doctors the confidence of quality and our focus on customer-centric approach. What were the quality measures taken by your company to achieve this certification? We follow stringent manufacturing processes and protocols to ensure that our instruments are in the same league as the international products. All our manufacturing sites are subjected to regular, periodical inspections for maintaining quality standards and to ensure compliance to local manufacturing guidelines and environment safety. We encourage improvisation in our systems by implementing feedback from our customers. Not to forget, we lay equal emphasis on the safety of our employees at the workplace. How does one go about getting this certification for medical device manufacturing? What are the pre-requisites? The pre-requisites for the medical device sector are no different from the other manufacturing sectors. An MSME applying to be evaluated on the ZED Maturity Assessment Model shall demonstrate and will be assessed and rated on the following parameters at the operational level: ◗ Enablers for Product Quality ◗ Enablers For Emission, Effluent and Waste Disposal Activities ◗ Enablers For Resource Management ◗ Outcomes ◗ The process flow encompasses the following steps: ◗ Online registration and self assessment ◗ Desktop assessment ◗ Site Assessment ◗ ZED rating and certification raelene.kambli@expressindia.com
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October 2019
LAB IN FOCUS
Suraksha Diagnostics: Betting big on automation The Kolkata-based diagnostics chain believes that success is not only in terms of generating the highest revenue rather in being successful to achieve a permanent place in the hearts of thousands of its customers by offering the latest technologies and world class services in a most affordable and customer-friendly way By Sanjiv Das
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utomation has helped diagnostics chains to improve operational efficiencies, maintain quality standards and minimise error. Kolkata-based Suraksha Diagnostics with the help of AI has been able to optimise its operations and make its tests more precise, safer and faster. The lab offers both diagnostic and polyclinic services to its clients and customers. In diagnostics, it offers services in pathology and radiology. Scope of pathology service extends to clinical biochemistry, haematology and immunohaematology, clinical pathology, histopathology and cytopathology, microbiology and serology, molecular pathology, molecular cytogenetics and LC-MS/MS. The radiology units have almost all modern and latest technologies like digital X-ray, USG, CT scan (16 slice), MRI (1.5 Tesla), mammography etc. and services are provided from SIEMENS, PHILIPS, GE Healthcare etc. The lab also offers cardiology (ECG, Echo, TMT, Holter monitoring), gastroenterology (endoscopy, colonoscopy etc.), neurology (EMG, EEG, NCV) and dia-
betes-related management of patients through more than 500 physicians. According to Dr Abhik Banerjee, Director- Quality Assurance and Senior Consultant- Pathology, Suraksha Di-
SPREAD ACROSS 40000 SQ FT AREA IN NEW TOWN, KOLKATA, THE LAB HAS TAKEN THE FULL ADVANTAGE OF AI AND AUTOMATION TO IMPROVE VOLUMES
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agnostics, has a centralised process for collection of blood samples to a single location. The lab provides for quick access to samples with specimen tracking, easy retrieval of requested samples, which are some of the features that truly transforms it into a smart, modern, clinical laboratory. Says Dr Banerjee, “We cater to a work load of approximately 7000 samples on a daily basis only in our reference lab, Kolkata. The Suraksha family consists of more than 1200 employees, 500 empanelled physicians, 50 inhouse radiologists, 20 laboratory consultants and an enviable number of supporting staffs.� Spread across 40000 sq ft area in New Town, Kolkata, the lab has taken the full advantage of AI and automation to improve volumes. It has recently incorporated 'Aptio' automation, the robotic track (track-based automation solution). So, how does the newly installed automation system benefit the lab?
THE JOURNEY SO FAR Having started as a single diagnostic centre at Phoolbagan in Kolkata in 1992, Suraksha Diagnostics, a CAP (College of American Pathologists) and NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratory (Suraksha Central Lab, Kolkata), have its centres and peripheral labs in West Bengal, Delhi and NCR and in Bihar. Even the satellite labs in Siliguri, Patna and Noida are NABL accredited.The chain is in the process of renewing its NABH (National Accreditation Board for Hospitals and Healthcare Providers) accreditation for all its centres.The diagnostic chain has also recently introduced robotic track-based automation (APTIO Automation), which effectively combines different clinical disciplines, test methodologies and analysers.
IT-enabled quality control mechanism
Automation-enabled smart lab APTIO Automation allows direct front-loading of urgent and low-volume samples to meet the most critical deadlines. The 26-metre long AIenabled robotic track comes with a complete range of pre and post-analytical sampleprocessing modules and the most advanced automated haematology, immunoassay and clinical chemistry analysers. Its automated sample loading and handling (tube sorting, offloading) feature helps laboratory staff from time-consuming, low-value tasks. The track-based automation solution, which effectively combines different clinical disciplines, test methodologies and analysers. APTIO automation also assists the staff to segregate different types of samples (EDTA whole blood, serum, urine), one from each other. The track also reduces pre-
its own molecular cytogenetics department. Apart from analytical area, digital token management system (Queue management), prefixed barcoding of vaccutainers, robust laboratory information management system (LIMS), dedicated CRM (customer relationship management) team, lab co-ordinator desk, SMS alert, mobile application, are some of the few of the numerous facilities offered by Suraksha. While the lab thrives on automation, it has also put in place a QA/QC mechanism that maintains high quality standards.
analytical errors by detecting any mismatch between test request and tube type, identifies problem samples (e.g., misread bar code, missing work order) and draws attention of the operator. It has established interfaces to analysers enabling faster routine
and specialty testing. Simultaneous STAT and routine testing on a single track with optional front-loading for urgent or low volume samples to instruments enables laboratory supervisors to deal with critical deadlines in a very user-friendly way.
Claiming to have introduced its LC-MS/MS (Liquid chromatography tandem mass spectrometry) for the first time in Eastern India for detection of inborn error of metabolism by newborn screening and 25 OH Vitamin D analysis, Suraksha also has
Suraksha Diagnostics has an experienced and qualified team of 'Laboratory Operations' and 'Central Quality cell' headed by Laboratory Director who is responsible for day-to-day lab activity, designing and preparing SOPs, quality policies, implementation of quality management system (QMS), internal audits, accreditation of the laboratory, selection and requirement of staffs including lab doctors and technicians, selection of equipment required, liasoning with the equipment vendors, selection of tests need to be outsourced, tie up with the other referral labs, introducing new tests, staff training, competency assessment and technical support to satellite labs. It has a dedicated IT cell which ensures seamless performance of the information systems during operations, server management, round the clock networking / connectivity, hardware and software maintenance, automation process, data security, retrieval of data and records management.
Managing the logistics While they maintain QA/QC mechanism, the lab also has a strong logistics system. At Suraksha, sample transporta-
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LAB IN FOCUS tion is one of the key areas which directly influence preanalytical quality of laboratory service and Suraksha is committed to ensure the best performance in this segment. The logistics service is outsourced to various agencies which are reputed and competent in handling biological samples. The logistic boys carry the sample from all centres to the laboratory where actual sample testing takes place. Dedicated supervisors/logistic officer from the agency coordinate with the courier boys and despatch officers of the centres. The supervisors report to the Sample Receiving In charge of the laboratory. Suraksha Diagnostics provides sample transportation bags (with Biohazard symbols) to all logistic personnel which carry sufficient gel packs, Ziplock bags, spillage kit etc. The logistic service is available from 7 am to 7 pm. Laboratory accession department can track the sample movement at any point of time from MICROSOFT DYNAMIC AXAPTA, the resource planning and management software. The despatch officer at centre and accession officer in lab are responsible to check and monitor the temperature of the samples during hand over (from centre to logistic boy and from logistic boy to lab accession department respectively) with the help of digital thermometer available inside each bag during each transport. Laboratory also maintains an error log system for monitoring the quality of submitted specimens and correcting problems, if any during sample transportation.
Partnerships and investments To improve and expand its services further, Suraksha Diagnostics has recently partnered with San Franciscobased biotech company which will focus on making translational genomics technologies
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accessible globally to enable quick detection of diseases at scale. Led by Dr Joydeep Mukherjee, a researcher in oncology and infectious diseases genomics in Toronto and UCSF, Cluegenix will make available to Suraksha the latest developments in molecular biology. The diagnostics chain has also partnered with several hospitals, corporate and government agencies to meet the needs of affordable and reliable diagnostic services. It also offers services for the beneficiaries under Central Government Health Scheme (CGHS) under Ministry of Health and Family Welfare, Government of India. Suraksha Diagnostics' APTIO automation itself costs in crores. Cutting-edge technologies like LC-MS/MS, NGS have incurred huge investments by the diagnostic chain since the last two years and there are plans to extend the services in other states including North East India.
The way forward In the years to come, Suraksha Diagnostics plans to come up with 10-15 new centres and four to six satellite labs in different parts of India. The cost of investment is projected to be Rs 70-100 crores. As they plan to expand their services, the only concern will be in maintaining the quality standards across all lab centres. As volumes grow, the diagnostic chain will require to balance between cost, quality and quantity in order to sustain the business in the long run. The question is that can the diagnostic chain afford to automate all its labs or will it continue to build on a centralised lab model and expand its collection centres. What strategy will the diagnostic chain adopt to thrive in the future? Will this Kolkata lab still remain the focal point of Suraksha’s success story? We will have to wait and watch! sanjiv.das@expressindia.com
ON THE EDGE
Changing healthcare landscape: The role of digital tools Dr Prashant Kumar Dash, Director-Medical Services, Medlife.com, states how digital technology, Internet access and innovation is transforming the health sector, making it more accessible and improving the quality of healthcare
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he life-expectancy of human beings has increased all over the world. At the same time, we are also witnessing a rapid increase in the burden of various health conditions, especially non-communicable diseases (NCDs). Each year, millions of people die of these diseases and tens of billions of dollars are lost. The limitations in the capability and coverage of the conventional healthcare system further aggravates the situation. However, in recent years, thanks to rapid advancement of digital technology, internet access and the emphasis on innovation, we are also witnessing a potential transformation in the health sector, more so in countries like India, where majority of the public is deprived of easy and timely access to quality healthcare. There is a realisation among healthcare providers, public and private authorities and diagnostic service providers alike that they must enhance their service offerings to meet this burgeoning demand for quality healthcare. Another change that has come about is with regards to an increased awareness about diseases and various treatment procedures among the common public. Patients today are not only seeking quality and effective care but are also aware of the latest practices and medicines. There is a growing preference for hassle-free digital interaction with medical service providers. In a recent survey, about 80 per cent of the doctors indicated that new age patients are
sonalisation and accuracy of services compared to conventional processes. Whether it be fixing appointments through an AI-based platform or making payments online, digital tools are not only more accurate but also make way for seamless customer experience.
Capacity enhancement
digital savvy and informed about their disease. The survey also found that about 31 per cent of patients use digital tools to search and schedule and another 27 per cent use online booking for diagnostic services. These numbers are expected to go up to 50 per cent in the next five years.1 For healthcare providers, the adoption of digital technology is no longer about having a website in place or importing advanced diagnostic devices. They also need to provide high-quality, impactful, easily available and economical services by integrating various digital tools.
rapidly making an impact in the healthcare industry by seamlessly integrating functions, making front-end management and diagnostic services easier and more economical, and improving customer experience. Some of their benefits include the following:
Digital tools have democratised the access to healthcare. Be it smart remote monitoring, wearable gadgets, or internetenabled diagnostic devices, these tools are making quality healthcare more accessible.
Digital healthcare tools are mass-service devices with a much-reduced human resources’ consumption. Hence, they enable providers to offer more efficient, expedited and economical services to their patients.
Digital tools in healthcare sector
Convenience
Accuracy
Digital technology has taken over front-end operations at
Digital technology-based tools offer a superior level of per-
most healthcare facilities all over the world. Self-service tools powered by internet and mobile apps take care of various services like appointment booking, report generation, telemedicine and online discussions with doctors and diagnostic experts.
Economy Access
While a front-desk executive would be able to manage one customer call or query at a given time, digital tools can simultaneously cater to a large number of people. For instance, a booking engine at a diagnostic lab would be able to provide personalised and seamless experience to over 1000 people at the same time and with absolute accuracy. Digital tools are rapidly expanding their footprint in the Indian healthcare market. There are various high-impact and affordable services like online diagnostic test bookings, home delivery of medicine, online doctor consultations and health-tech enabled home healthcare which are becoming increasingly popular. Innovations have made diagnostic and monitoring tools less intrusive and cumbersome. Given the current rate of innovation and improvement, the day is not far when digital tools will potentially and positively alter the healthcare landscape around the world.
Reference: Digital healthcare tools are
1.A Bain Capital-Confederation of Indian Industries (CII) 'India Doctor Survey'
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October 2019
TIMEOUT
Balance of mind improves productivity Zoya Brar, Founder and CEO, CORE Diagnostics shares what drives her, how she handles work and what are the changes she has incorporated into her life to make it better than it already is By Prabhat Prakash
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imes have changed and life has become more demanding with every passing day. Gone are the days where one would take time off from work and not worry about it. Today with advancements in technology, all our work is integrated into our personal lives and with the devices that make our work easier. Even during leisure time, we subconsciously take time out for work. Zoya Brar, Founder and CEO, CORE Diagnostics is a firm believer of leisure time being a myth. Brar is a very proactive individual with a vision. She has a degree in Sociology and has even worked for Google. But corporate life wasn’t for her and in 2012 she founded CORE Diagnostics and hasn’t looked back since. Her business in the last seven years has almost grown 100 per cent on a monthly basis. Brar has achieved all of this at a very young age but she still isn't done yet. Brar exclaims, “Personally, my current journey feels more like a life transformation and less like a career. Almost like I am on a mission to help people feel safe, feel free. Most things I do these days are motivated by that.” Being an entrepreneur, Brar doesn’t want to establish her business and make millions but wants to help those that are in need. She wants to be a difference maker and is striving to achieve that. Brar is mostly busy with work but that doesn’t deter her in taking out time for doing things she really loves.
Work life balance Brar is very practical in her approach towards her work life. She states, “Balance comes from knowing what gives you happiness and optimising for
24 EXPRESS DIAGNOSTICS October 2019
MAKING AN IMPACT IS ALWAYS CHALLENGING BUT IT IS ACHIEVABLE IF ONE TAKES OUT TIME FOR ONESELF TO INTROSPECT AND REJUVENATE
that and often it comes from surrounding yourself with people that love you for what you are passionate about.” She believes that people are the same and not divided. It is the same individual that goes to work and the same person returns home. The difference is that individuals are performing different duties at home and at
work, they aren’t two different identities. This makes it very important to be around people that are supportive, helpful and encouraging. Otherwise, it becomes a difficult task to achieve one’s goals and potentials. Making an impact is always challenging but it is achievable if one takes out time for oneself to introspect and rejuvenate.
Learning other art forms Well this isn’t very difficult for Brar to speak about. She doesn’t mince her words here when asked about learning other forms of art. Brar says, “Given that I am a self-described poet and sociologist, this question is kind of moot.” In her spare time she pens down poetry and is also working on her book which is a work of fiction. She is an avid reader and about her choice of books Brar states, “I have an eccentric choice. Anything from books that help me think about the tough questions (The Road Less Travelled by M Scott Peck), to those
that help me just lose myself for a bit, to those that help me wonder and marvel at life (usually poetry).” She also coaches people to become a better version of themselves. And whenever time permits, she indulges in travelling. She loves visiting places that are by the ocean, the water in many ways liberates her.
Time off from technology Technology today is integrated into our cores, we cannot do
without technology. Our lives are incomplete without the involvement of technology in some form or the other. The same cannot be said for Zoya as she enjoys disconnecting from gadgets. She was active on various social media platforms but has now quit most of them. She has even gone to the extent of muting notifications on her phone. Brar states, “I have all my notifications off and have quit most social me-
dia platforms. The peace of no interruption is what I would wish for all my peers.” This makes life simple for her, no worries of a world that doesn’t exist, living in the moment and taking life as it comes.
Message to peers It is very important to be mentally stable no matter what an individual is doing. Being mentally stable not only makes an individual more productive but
also helps elevates the mood and works of co-workers. “Work-life balance is a myth. Balance of mind and being aware of what holds you back and what drives you is what one should strive for,” states Brar. Life is a work in progress and one should always strive to be the best that they can be at work or at home. Life is beautiful and one should cherish every moment of it. prabhat.prakash@expressindia.com
EXPRESS DIAGNOSTICS
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October 2019
TRADE AND TRENDS
'HaematologyAutomation' must follow 'Manual Techniques' but when? What research says? Dr Rajeev Gautam, President, HORIBA India elaborates on the importance to observe a blood film under a microscope in case of doubt or discrepancy in routine results shown by haematology analysers
A
round half-a-century ago, automated haematology analysers were introduced, which are now evolving and becoming more sophisticated with every passing year. Manual techniques, especially to prepare a stained blood film and observe under a microscope is becoming a complementary activity of a laboratory in case there is a doubt or discrepancy in routine results shown by haematology analysers on a particular patient’s blood sample. According to Bains, Blood smear Reviews (BSRs) and Manual Differential Leukocyte Count(MDLCs) are laborious and expensive too thus they are not affordable for many samples and with every work-load scenario. As the technical capability and analytical performance of an analyser is getting more refined, the utility of automated analyser and subsequent complementary slide review is changing based on multiple factors that may influence results. These may include age, gender, demography, laboratory, geography and level of automation as well, which makes the utility of manual review a subjective one. A good practice of manual review done by one lab in a particular geography maybe a sheer wastage of time for another laboratory with different factors mentioned above. Across countries, there is little uniformity on criteria-foraction to the following dilemma, of when to complement the automation results with microscopic evaluation of
26 EXPRESS DIAGNOSTICS October 2019
manually stain blood film.
Rules Of Review Criteria In 2002, General Accepted Guidelines were developed by Dr Berend Houwen, where he called 20 experts on subject to discuss and determine the most appropriate criteria that can be uniformly applicable throughout laboratories across the world. This group is known as an “International Consensus Group for Haematology Review.” This group meticulously considered all possible conditions that may affect the results of automation and contemplated upon the issue of when to complement the results of automation with stained blood film examination. Total of 83 Rules were formulated in the first draft and then further subjected to 15 well-reputed laboratories for testing on a total of around 13,298 routine blood samples. Following detailed clinical considerations and statistical analysis, rules were further refined and consolidated
and only 41 rules were considered to be included in the final version. These were published in 2005 by Dr Berend Houwen. These rules consider age, gender, first time samples, repeat samples based on delta rules, screening thresholds and presence or absence of specific suspect flags and alarms given by the automated haematology analyser. These rules were prepared as a comprehensive assistance to all hematology laboratories across the world. However, before implementing them in any laboratory’s routine operations, they need to be validated and a protocol has been suggested by the consensus group for the same.
Rules And Their Application By Haematology Laboratories ◗ Cost Reduction ◗ Reduce Turn-Around-Time (TAT) of Results (without sacrificing quality) ◗ Justify performance and skills of automated multi-para-
metric haematology analysers. These rules also help in distinguishing samples with a high probability of containing relevant morphological alterations for the better and timely diagnosis and treatment of patients. All haematology laboratories are encouraged to establish their own locally valid protocols indicating when should they review the smear and when to perform manual differential. These guidelines developed by the International Consensus Froup of Haematology review may act as a starting point, however, they must be interpreted in consideration with experience of the laboratory staff, sophistication of the haematology analyser, electronic recording system, estimated incidences of abnormalities and variations in population reference values being tested. The use of review criteria which would allow the release of automated counts without a BSR, is neither a widespread, well-accepted or standardised procedure. Some of the laboratories even use these published rules without any local customisation or validation and without any empirical evidence available for the same. Many of the healthcare laboratories and hospitals have conducted validation studies on these established rules, whether these are applicable or not to their particular laboratory. Study by Comar SR, from Brazil, unearthed that amendments are required especially
in ‘Delta Check’ rules. Delta limits are found to be established by each laboratory taking into account the physiopathological aspects and technical characteristics of the automated analyser used. The delta check rules play an important role in the efficiency and reliability of the CBC results but many clinical laboratories are incapable of implementing them in their electronic records because of high software development costs. Another reason is that most of the laboratory professionals are not very familiar with these rules, which make their understanding, dissemination and implementation further difficult. The ISLH does not suggest any specific ‘Delta Check limits’ leaving them to the discretion of the laboratory. The consensus group only suggests specific actions for situations in which Delta limits exceeded from the established ones by each individual laboratory.
Summary Current literature categorically says that the criteria established by the International Consensus group, must be further evaluated considering local peculiarities, demography, technology usage, climatic conditions, pathological and physiological considerations. However, studies are further going on across countries to check the utility and scope of establishing new criteria or better adaptation protocols for the existing one.
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