CONTENTS NEWS
STRATEGY
Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty
5
INCIDENCE OF POORLY CONTROLLED DIABETES HIGHEST IN AGE GROUP OF 50-60: METROPOLIS’ STUDY
7
TRANSASIA BIOMEDICALS TO FORAY INTO RS 300 CRORE INDIAN MOLECULAR DIAGNOSTICS SPACE
Editor Viveka Roychowdhury* BUREAUS Mumbai Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Prabhat Prakash, Tarannum Rana Delhi Akanki Sharma Bengaluru Usha Sharma Design Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht
8
TRANSASIA BIO -MEDICALS UNVEILS ‘LISA XL’, A SIX PLATE ELISA PROCESSOR
9
METROPOLIS HEALTHCARE RELEASES FINANCIAL RESULTS FOR Q2
Digital Team Viraj Mehta (Head of Internet) 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
Aster DM Healthcare has taken another winning leap by introducing Aster Labs.With this new venture,Aster aims to create a consortium of care for India and earn maximum market share in healthcare | P-20
POST EVENTS
Graphics Designer Gauri Deorukhkar Artists Rakesh Sharma
ASTER LABS: THE NEW BABY ON THE BLOCK
10
MOREPEN LABS REPORTS 24 PER CENT RISE IN NET SALES IN FIRST HALF OF FY 2019-20
11
SRL DR AVINASH PHADKE LABS UNVEILS ‘MUMBAI’S ANTIMICROBIAL RESISTANCE REPORT, 2019’
12
CANCER CARE
AACC INDIA SECTION CME ON CLINICAL CHEMISTRY AND IMMUNOASSAY HELD IN MUMBAI
LAB IN FOCUS
22
DR DANGS LAB: 'CREATING VALUE NOT VOLUMES'
24
VANQUISHING CANCER WITH GENOMICS
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.
EXPRESS DIAGNOSTICS
3
November 2019
EDITOR’S NOTE
How POC diagnostics are as essential as life saving medicines
A
ccording to WHO statistics, across the world, Antimicrobial Resistance (AMR) kills an estimated 700 000 people annually, including 230000 from multi-drug resistant tuberculosis. As we put one more World Antibiotic Awareness Week behind us, will we lose sight of the dire situation in India? Imagine the scene in a doctor’s clinic in Mumbai or any one of India’s metros. Crowded, children crying, people coughing. The lone doctor struggles to cope with the load, especially during monsoons, when infections spread easily. She gets just a few minutes per patient, to decide the course of treatment. The doctor‘s decision in those crucial moments is crucial to the AMR crisis. Because if the doctor misdiagnoses a viral infection for a bacterial one, and prescribes an antibiotic, the patient might just be one step closer to creating antibiotic-resistant microbes. Because antibiotics don't work against viral infections so not only did the patient pay for medicines she did not need, but she also runs the risk that the bugs will be resistant to these antibiotics the next time she really needs them. Even if the doctor doesn’t prescribe antibiotics, many patients will either pester the doctor to prescribe an antibiotic or self medicate. What if the doctor could prescribe a quick blood test to get a more definite idea of the patient’s illness? Rather than relying solely on symptoms reported by the patient, the doctor now has evidence to base her decision on. The next step is, if its a bacterial infection, can the test also identify the drug resistance profile and extent of the infection? Therefore, without POC AMR diagnostic tests, doctors are really just shooting in the dark. The hallmarks for such a diagnostic test are that it should be easily administered at the point of care (PoC), which is either the doctor’s clinic, a primary health centre or a patient’s home. Mindful of the doctor’s time and an impatient patient, the test results need to be delivered quickly as well. Many tests, therefore, aim for same-day results. And of course, the test needs to be low-priced. The need for AMR related diagnostics has spurred the POC diagnostics market and there are reportedly quite a few innovative tests in the pipeline. Most tests call for genome sequencing, specific DNA probe detection (e.g. using PCR) and quantitation; and proteomic mass spectrometry. Policymakers too have started various schemes to encourage research in AMR diagnostics. For instance, the Indian governments' BIRAC has awarded grant funding to many startups developing POC tests, especially in this segment. Startups have stepped into the fray as bigger diagnostics majors have been traditionally averse to invest in low priced tests, preferring high-end lab-based tests. But the
4
EXPRESS DIAGNOSTICS
November 2019
Without POC AMR diagnostic tests, doctors are literally shooting in the dark
size of the POC market is seeing renewed interest from the diagnostic majors as well. Private organisations have started competitions in AMR diagnostics to spur researchers. A good example is the Longitude Prize, a challenge with a prize fund of £10million, and an £8m pay-out to the winner, which was launched in 2014. Most of India’s leading diagnostics chains do have tests along these lines and are closely watching this space to add more such tests to their bouquet. Some diagnostic labs have started initiatives to collect data and look for trends in infections reported, as well as antibiotic resistance. For instance, SRL Dr Avinash Phadke Labs recently unveiled a report on Mumbai’s antimicrobial resistance, based on the study of 40500 selected samples received over nine months (January to September 2019) from Mumbai. Top findings of the report include a list of bacterial organisms affecting Mumbaikars, the top infections caused by these organisms, the antibiotics Mumbaikars are most resistant to and those that could be possibly used against drug-resistant bacteria cases. The sample size is small and confined to just one city, but the key insights from this report should convince more diagnostics labs to conduct such studies, with larger sample sizes and across more cities. These studies could then become a rich source of epidemiological data to track AMR. Policymakers and private funders in healthcare care should heed the warning in Longitude Prize Patent Report 2018. Given that large companies would rather invest in laboratory-based testing than POC kits, thanks to the larger ticket size, the writers suggest that policymakers will need to ring-fence funds to assure that products are purchased and new norms are created, whereby, biological testing before antibiotic prescribing becomes the norm. The report also forecasts that for low and middle-income countries (LMICs), there will likely be a need to prime the market, as was done with diagnostics for AIDS, tuberculosis and malaria. Lastly, the WHO statistics have some sobering facts for India. By 2050, unless urgent action is taken, AMR is expected to kill 10 million annually, of which two million will be Indians. Therefore, it is imperative that researchers, investors, policymakers and doctors step up efforts to develop quicker, more easy-to-use POC tests which can be used by doctors before they start treatment. The good news is that some promising startups are doing good work in this segment. Let's hope they find the ecosystem to scale up and launch as early as possible.
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
NEWS
Incidence of poorly controlled diabetes highest in age group of 50-60: Metropolis’study About 25 per cent of samples tested for HbA1c reported levels greater than 8 per cent, which means that their blood glucose levels are not controlled
T
he incidence of poorly controlled diabetes was found to be the highest in the age group of 50-60 years (about 32 per cent), followed by 60-70 years (about 29 per cent) and
40-50 years (27.6 per cent). The incidence was the lowest in the age group of 20-30 years (10 per cent) but increased steadily to peak in the age group of 50-60 years. It thereafter showed a
steady decline in the older age groups. Interestingly, 22.7 per cent of all females tested were found to suffer from poorly controlled diabetes, compared to 28 per cent for
males. Out of more than half a million samples tested at the company’s global reference laboratory in Mumbai, almost 23 per cent were found to be in pre-diabetic stage,
about 29 per cent were found to be diabetic, while 22.6 per cent tested non-diabetic. About 25 per cent of samples tested for HbA1c reported levels greater than 8 per cent, which means that
EXPRESS DIAGNOSTICS
5
November 2019
NEWS ANALYSIS OF 532182 SAMPLES TESTED FOR HBA1C IN MUMBAI Age Group
Normal
Pre-Diabetic
Diabetic
Poorly controlled diabetes
20 to 30
65.07
17.49
7.41
10.03
30 to 40
42.33
23.92
16.00
17.75
40 to 50
21.68
24.36
26.33
27.63
50 to 60
11.33
22.60
34.05
32.02
60 to 70
8.82
22.08
39.85
29.25
70 to 80
9.35
24.78
42.17
23.70
Above 80
13.05
29.61
39.51
17.84
Average
22.67
23.02
28.95
25.36
Gender
Normal
Pre-Diabetic
Diabetic
Diabetic with Poor Control
Female
26.64
24.11
26.52
22.73
Male
18.54
21.89
31.48
28.09
their blood glucose levels are not controlled. Prolonged high blood glucose levels put diabetic patients under risk to develop diabetes-related complications. (Please see figures in the table above) Commenting on the study, Dr Mayur Nigalye, Deputy Chief of Lab, Metropolis Healthcare said, “Diabetes is a growing challenge in India with estimated 8.7 per cent diabetic population in the age group of 20 and 70 years. The rising prevalence of diabetes and other non-communicable diseases is driven by a combination of factors – rapid urbanisation, sedentary lifestyles, unhealthy diets, uncontrolled use of alcohol and tobacco. Lifestyle interventions (sleep, exercise and diet modifications) along with regular monitoring is a must for diabetes management.”
For the purpose of this data analysis: ◗ Data for samples tested for HbA1c was collated for over
6
EXPRESS DIAGNOSTICS
November 2019
a period of five years ◗ Sample data of repetitive patients were removed and only one single reading from a patient was used for the study ◗ Sample was analysed by applying the reference range from 2019 ADA Guidelines
ADA 2019 Reference Range for HbA1c ◗ Result ranges below 5.7 per cent – Normal ◗ Result ranges between 5.7 per cent and 6.5 per cent – Prediabetes ◗ Result ranges greater than 6.5 per cent and below 8 per cent – Diabetes ◗ Result ranges above 8 per cent – Poorly controlled diabetes ◗ A1C Testing – Recommendations Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control). Perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals. Point-of-care testing for
A1C provides the opportunity for more timely treatment changes. 1. United Kingdom Prospective Diabetes Study Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352: 837–853, 1998 2. Nutrition and lifestyle intervention in type 2 diabetes: pilot study in the Netherlands showing improved glucose control and reduction in glucose lowering medication (Pot GK, et al. bmjnph 2019;0:1–8.). British Medical Journal, Prevention and Health Research has shown that people with type 2 diabetes who reduce their HbA1c level by 1 per cent are: ◗ 19 per cent less likely to develop cataracts ◗ 16 per cent less likely to have a heart condition ◗ 43 per cent less likely to undergo amputation or death due to peripheral vascular disease
Transasia Bio-Medicals to foray into Rs 300 crore Indian molecular diagnostics space Developed by Erba Molecular, MX 16 is a fully automated nucleic acid extractor, which was unveiled at 50th Union World Conference on Lung Health and TB in Hyderabad
T
ransasia Bio-Medicals recently announced that it will soon be foraying into the Rs 300 crore Indian molecular diagnostics space. It unveiled the MX 16, a fully automated nucleic acid extractor, at the 50th Union World Conference on Lung Health and TB in Hyderabad. The MX 16 has been developed by Erba Molecular, a UK subsidiary of the TransasiaErba Group. The new system will offer an easy-to-use and lower priced molecular TB test in India, with the goal of replacing traditional smear microscopy. The system will be particularly beneficial to India, which has the highest burden of TB and drug-resistant TB: One in four TB patients globally are in India. Also, 89 per cent of affected individuals in India are in the productive age group 15-69, which makes it a critical national health issue to be addressed. Though TB incidence in India has been declining at 1.7 per cent annually since 2016, it is estimated that it needs to fall by 10 per cent annually to reach the Government’s 2025 goal of ending TB in the country. Currently a significant number of TB patients remain undiagnosed for long and out of those diagnosed, only 65 per cent of cases in India are treated. According to the Tuberculosis India Report 2019, there has been a 16 per cent increase in cases compared to 2017, further raising the need for early, simple and accurate diagnostics, which is a crucial element of any successful strategy to address TB in India. To this effect, Molecular testing has been included in first ever Essential Diagnostics List announced in 2018 by the WHO,
THE NEW SYSTEM WILL OFFER AN EASY-TO-USE AND LOWER PRICED MOLECULAR TB TEST IN INDIA, WITH THE GOAL OF REPLACING TRADITIONAL SMEAR MICROSCOPY
further stressing the need for timely diagnosis of TB. Announcing the foray, Suresh Vazirani, Chairman and Managing Director, Transasia-Erba International Group said, “Erba Molecular in UK is among a handful of companies in the
world having state-of-the-art, proprietary molecular diagnostic technology. The unveiling of MX 16 and our upcoming entry into the molecular diagnostics segment in India, is part of our commitment to bringing the best in IVD globally to benefit the In-
dian public. We have also been careful to ensure the forthcoming MX 16 system offers better sensitivity compared to others in the space, with a target price which is significantly lower, to ensure access to early, accurate TB diagnosis. With 21.5 lakh cases reported in 2018 and many more that remain undiagnosed, I personally think it is the right time for us to introduce our molecular range and we look forward to partnering with the health ministry for a TB- free India.” In his comments, Dr Laurence Tisi, President, Erba Molecular, said, “Our technology makes molecular diagnostics less complex and replaces the age-old smear microscopy method for TB detection. With 75 per cent reduction in processing time and the ability to run 16
samples concurrently, MX 16 allows for faster turnaround time (TAT). It is fully automated, with a protocol incorporating a unique kill step that enhances lab worker safety during sample preparation. The new solution from Erba will help deliver easy and faster diagnosis, a big benefit in densely populated countries like India.” He further added “We are also planning to bring in NexGen sequencing and other advanced technologies which extracts genetic information from patients and helps to plan treatment needs. The presence of large patient pools suffering from infectious diseases like TB and HIV has created an immense unmet need for superior diagnostic technologies. With current tests prone to delivering false results because of lack of sensitivity, we are working on a comprehensive suite of molecular testing products for other infectious diseases and cancer markers which will use the same MX 16 platform.” Vazirani further added, “Emerging markets like India are the main focus of TransasiaErba Group as they face a higher burden of TB and the challenge of drug resistance. MX 16 being a flexible molecular platform, we plan to add more menus in the future to make it a comprehensive molecular solution. Our ambitious goal is to offer TB test automation at under $10. The initial response has been highly promising. The team at Transasia-Erba Group is truly proud of developing a solution that directs the power of molecular testing to the increasingly important battle of a TB-free future.”
EXPRESS DIAGNOSTICS
7
November 2019
NEWS
Transasia Bio -Medicals unveils ‘Lisa XL’, a six plate ELISAprocessor Lisa XL can perform up to 576 tests at one go, making it a preferred choice for laboratories and blood banks with high workload
T
he Transasia-Erba group recently unveiled Lisa XL, a six plate ELISA processor at the 15th Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicine Congress (APFCB) being held in Jaipur. The device was formally unveiled by Prof Praveen Sharma, Chairman, Organising Committee, APFCB Congress, in the presence of Ravi Kaushik, CEO, Transasia Bio-Medicals, Anil Jotwani, Sr President, Transasia Bio-Medicals and Louis Villar, Commercial Manager, South-East Asia, Erba Group. Designed at Transasia-Erba’s European subsidiary, Lisa XL can perform up to 576 tests at one go, making it a preferred choice for laboratories and blood banks with high workload. Transasia also displayed its entire suite of products in Biochemistry, Urinalysis and Haematology at the conference. The new instrument is already registered with the Government e-Marketing (GeM) a government digital emarket platform to sell Lisa XL. Commenting on the new equipment, Jotwani said, “Today blood banks have to ensure stringent screening with quality instruments and reagent kits. Considering the high volume of testing in India, there is a need to equip blood banks here with the latest technology that enable faster diagnosis without compromising on quality. Also shorter turnaround time also leads to lower cost per test which is important consider-
8
EXPRESS DIAGNOSTICS
November 2019
ing pricing is a major factor in India. Microplate processors in India are one, two or four plates. By introducing a six plate processor, the first in the country, we are targeting large blood banks. The new Lisa XL is part of our commitment to making healthcare affordable in India through delivery of world-class diagnostics at competitive prices.” A complete walk-away system, Lisa XL offers a host of features to maximise the efficiency of ELISA processing.
Dual probes with powerful robotic engineering allow simultaneous and sequential dispensing of samples in less than 14 minutes and reagents in less than five minutes in 96 wells. Lisa XL processes serum and whole blood simultaneously. For greater accuracy, each microplate has a dedicated temperature controlled incubator with orbital shaking at variable speed. Further, multiple aspiration and Super Sweep Mode ensures superior washing with
minimal residual volume. The new Lisa XL will be highly beneficial in high workload settings for the accurate detection of transfusion transmitted infections like HIV, hepatitis B, hepatitis C, malaria and syphilis among others which are transmitted through blood. Not just the TTIs, Lisa XL is beneficial to evaluate a wide range of other biochemical markers for diabetes, steroid, inflammatory, autoimmune disorders, bone metabolism, tumour, cardiac
and anaemia markers which can be performed by ELISA in high workload settings. Villar speaking about Erba’s plan for the SouthEast Asian market he added, “We are very excited to be able to serve our customers across South-East Asia and support our channel partners from within Vietnam. We have a dedicated team ready to support our customers with application and service expertise as well as sales and marketing.”
Metropolis Healthcare releases financial results for Q2 In focussed cities B2C revenues have grown to Rs 131 cr registering growth of 17 per cent on YoY basis
M
etropolis Healthcare recently announced its un-audited consolidated financial results for the quarter ended September 30, 2019.
Key Highlights H1FY20 Overall revenue from B2C stood at 44.4 per cent in H1FY20 as compared to 43.6 per cent in H1FY19. In focussed cities B2C revenues have grown to Rs 131 cr registering a growth of 17 per cent on YoY basis. B2C share in focussed cities was higher at 56 per cent as compared to 52 per cent in H1FY19. Acquisition of four front end labs in Surat has helped us ex-
pand our market share in this focus city.
Our Delhi Regional Reference Lab has been relocated
and expanded to 15,000 sq ft from 8,000 sq ft earlier which
allows us for test menu expansion, faster turn around time. A total of 14 new tests (in areas of Genomics, Onco-pathology, new-born screening and transplant pathology) have been validated and added to the test menu in H1FY20 thus expanding our capabilities to do more specialis ed tests. A few technology and digital initiatives have gone live in H1FY20 that enables better control, data security, business continuity, business revenue generation capabilities, improved operational efficiency, efficiencies in productivity and an improved customer experience.
CONTRIBUTOR’S CHECKLIST ●
●
●
●
●
Express Diagnostics accepts editorial material for the regular columns and from preapproved contributors/ columnists. Express Diagnosticcs has a strict non-tolerance policy towards plagiarism and will blacklist all authors found to have used/referred to previously published material in any form, without giving due credit in the industry-accepted format. As per our organisation’s guidelines, we need to keep on record a signed and dated declaration from the author that the article is authored by him/her/them, that it is his/her/their original work, and that all references have been quoted in full where necessary or due acknowledgement has been given. The declaration also needs to state that the article has not been published before and there exist no impediment to our publication. Without this declaration we cannot proceed. If the article/column is not an original piece of work, the author/s will bear the onus of taking permission for re-publishing in Express Diagnostics. The final decision to carry such republished articles rests with the Editor. Express Diagnostics’s prime audience is senior
● ●
●
●
●
●
● ●
management and professionals in the hospital industry. Editorial material addressing this audience would be given preference. The articles should cover technology and policy trends and business related discussions. Articles by columnists should talk about concepts or trends without being too company or product specific. Article length for regular columns: Between 1300 - 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant. We welcome information on new products and services introduced by your organisation for our Products sections. Related photographs and brochures must accompany the information. Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. You may write to the Editor for more details of the schedule. In e-mail communications, avoid large document attachments (above 1MB) as far as possible. Articles may be edited for brevity, style, relevance. Do specify name, designation, company name, department and e-mail address for
●
feedback, in the article. We encourage authors to send a short profile of professional achievements and a recent photograph, preferably in colour, high resolution with a good contrast. Email your contribution to: viveka.r@expressindia.com Editor, Express Diagnostics
EXPRESS DIAGNOSTICS
9
November 2019
NEWS
Morepen Labs reports 24 per cent rise in net sales in first half of FY 2019-20 In the first half of FY 2019-20, the company witnessed 34 per cent rise in its net profit
M
orepen Laboratories has reported a net sales revenue (standalone) of Rs 383.30 crore in the half year ended September 30th, 2019, registering a growth of 24.2 per cent as compared to the net sales revenue of Rs 308.56 crore in the corresponding first half of the previous fiscal. Total revenue (standalone) in first half stood at Rs 392.44 crore (Rs 313.06 crore) registering a jump of 25.4 per cent. EBIDTA was up by 31.8 per cent in H1’ FY 2019-20 at Rs 37.44 crore (Rs 28.40 crore) and cash profit during the same period was up by around 32.4 per cent at Rs 36.63 crore (Rs 27.67 crore). The net profit before tax (standalone) almost doubled in the first half at Rs 18.10 crore compared to Rs 9.65 crore in the corresponding first half of previous fiscal. The net profit after tax (standalone) during the period stood at Rs 12.95 crore, up by 34.1 per cent from Rs 9.65 crore net profit registered in the corresponding period of FY’2018-19. The half yearly net profit has increased by a good 34 per cent despite a one-time hit of Rs 5.15 crore taken by the company by writing off MAT credit entitlement in line with the new Taxation Laws (Amendment) Ordinance 2019 in Q2 FY 2019-20. The overall home diagnostic segment recorded total sales of Rs 85.55 crore in H1 FY 2019-20, registering a rise of 23 per cent vis-a-vis corresponding period of the previ-
10
EXPRESS DIAGNOSTICS
November 2019
ous fiscal. Blood glucose monitors and nebulisers recorded the highest growth in the half year at 33 per cent and 60 per cent, respectively. The combined sales revenue of the two devices in the half year increased to Rs 78.01 crore as compared to Rs 61.19 crore in the corresponding period of previous fiscal, registering a growth of 27 per cent. Looking at increasing incidence of diabetic cases in India, the blood glucose monitors and blood pressure monitors segment offers great opportunity for growth in the coming years. In all, around 360 mil-
lion glucometer strips have been sold by the company till date and blood glucose monitors installations have crossed 3.2 million target. OTC business has recorded growth of 11 per cent in its sales revenue in H1 FY 2019-20. Isabgol and other small base brands grew by 36 per cent and 105 per cent respectively. OTC Business witnessed launch of many new products to its health basket including Active Smile, Dr Morepen Daily, MTP Kit, VCALCI, Clean & Pure, Liv Healthy, Head-X, Dr Morepen Aid, Dr Morepen Buds,
COLD-EX, Paachan-Arishta and Adult Nasal Spray in various new product categories. New products are expected to add significantly to the company’s topline in the coming quarters. The company has reported a net sales revenue (standalone) of Rs 196.60 crore in Q2’FY 2019-20, registering a growth of 23 per cent vis-a-vis net sales revenue of Rs 159.73 crore in Q2 FY 2018-19. Its EBIDTA in Q2 FY 2019-20 increased by seven per cent at Rs 17.71 crore and cash profit increased by 6.4 per cent at Rs 17.32 crore as against Rs 16.59
crore and Rs 16.28 crore, respectively, in the corresponding quarter of the previous fiscal. The net profit before tax (standalone) for Q2 FY 201920 stood at Rs 9.69 crore, registering a rise of 36.4 per cent. However, as aforesaid, on account of the one-time hit of Rs 5.15 crore taken by the company during the quarter by writing off its MAT credit entitlement, the net profit after tax (PAT) decreased by 38 per cent at Rs 4.54 crore compared to Rs 7.29 crore in the corresponding quarter of the previous fiscal.
SRL Dr Avinash Phadke Labs unveils ‘Mumbai’s Antimicrobial Resistance Report,2019’ AMR differs regionally, it is important for stakeholders to be aware of trends impacting the city, so that precautionary, corrective measures can be taken to limit spread of antibiotic resistance
S
RL Dr Avinash Phadke Labs, recently unveiled ‘Mumbai’s Antimicrobial Resistance Report, 2019’ highlighting the patterns observed in bacterial infections and antibiotic resistance affecting Mumbaikars. The objective of the report is to contribute to the reduction of Antimicrobial Resistance (AMR) that is impacting people world over. AMR differs regionally and it is important for all stakeholders to be aware of the trends impacting the city, so that precautionary and corrective measures can be taken to limit the spread of antibiotic resistance. The report is based on the study of 40500 selected samples received over nine months (January to September 2019) from Mumbai. Top findings of the report are as follows: Top bacterial organisms affecting Mumbaikars: Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Acinetobacter baumannii, Salmonella typhi. Top infections caused by these organisms are: urinary tract infections (UTIs), soft tissue/wound infections, respiratory tract infections, typhoid and sepsis. Antibiotics Mumbaikars are most resistant to: Penicillin, Cephalosporin (up to 2nd generation) and Fluoroquinolones (up to 2nd generation) The report also highlights antibiotics that could be possibly used in drug resistant bacteria cases. Commenting on the cause, Dr Ajay Phadke, Centre Head, SRL Dr Avinash Phadke Labs, said, “Antimicrobial resistance
About a third of clinically suspected samples showed bacterial growth. This emphasises the importance of sending samples before initiation of antibiotic. A PCR based method can still detect organisms after the first few doses of antibiotics. The primary data indicates a need of laboratory surveillance for Antimicrobial Resistance (AMR). Building on local epidemiology data is important to rationalise antibiotic usage.
For General Public
has become a global concern and the onus of reducing its spread lies on each one of us. Efforts need to be made right from infection control to judicious use of antibiotics. A shift in the way diagnosis of bacterial infections is ordered and antibiotics are administered is critical. Even the general public needs to be made aware about the ill effects of irrational and rampant antibiotic usage. On a broader level, regional monitoring of AMR and improvement of local antimicrobial stewardship is required. Technology backed platforms can be used to integrate information on antimicrobials and resistance from different localities so that clinicians are aided in offering better patient care and fighting AMR through a connected approach.”
Key Insights Most organisms identified are
spread through water and food contamination. Transmission can occur via infectious persons or environmental surfaces. Antimicrobial resistance bacterial strains are hospitalacquired as well as communityacquired community. These drug resistant strains are circulating among humans, animals and environment in healthcare as well as nonhealthcare settings, emphasising on the need of infection control in both settings. Increasing antibiotic pressure with age and exposure: Fluoroquinolones (Up to the 2nd gen): The resistance increases across age groups. Adults have more resistance than children. This could be due to irrational use of antibiotics. Older antibiotics such as Aminoglycosides were prescribed less due to prior resist-
ance. This could explain a rise in their sensitivity. Judicious use of Aminoglycosides can be considered.
Key takeaways for clinicians The use of minimum inhibitory concentrations (MIC) is essential. This helps clinicians to choose the right antibiotic with the optimal dose. Pseudomonas strains are resistant to most antibiotics. Strict infection control practices are crucial in all OPD and IPD settings. Given the unpredictable resistance patterns of different bacteria, use of a culture/PCR based assay should be encouraged in all hospital settings. This will help in modifying empirical treatment based on susceptibility obtained. Many PCR assays now provide drug resistance along with identification.
Maintaining hand hygiene is critical for reducing the spread of organisms and thus prevention of AMR. Maintaining better water quality and sanitation can significantly help the cause. Fever is not necessarily a sign of a bacterial infection. They can be viral infections which recover without antibiotics. Always seek advice/ prescription of a qualified medical professional before taking antibiotics. Antibiotics prescribed to you should only be taken by you. The same antibiotics shouldn’t be taken by your friends or family without consulting a qualified medical professional. Do not insist on antibiotics if your doctor says you don’t need them. Adhere to the antibiotic dosage prescribed by your doctor. Do not modify its quantity or consumption duration on your own. Always ensure that the medicines you are buying directly from pharmacies, without a prescription, are not antibiotics.
EXPRESS DIAGNOSTICS
11
November 2019
POST EVENT
AACC India Section’s CME on clinical chemistry and immunoassay held in Mumbai Experts present at the CME spoke about different tools that can be instrumental in overcoming a range of challenges in the lab
R
ecently in Mumbai, the AACC India Section organised a CME on Clinical Chemistry and Immunoassays: From bench to bedside at Kokilaben Dhirubhai Ambani Hospital. The CME attracted some of the top-notch leaders and researchers from India and abroad. This gathering fo-
12
EXPRESS DIAGNOSTICS
November 2019
cussed on discussing the recent developments in clinical chemistry laboratory testing, lab automation, standardisation of assays and method validations as well as aimed at addressing challenges and interferences in immunoassay. Experts present at the CME spoke about different
tools that can be instrumental in overcoming a range of challenges in the lab. Students present at the CME had the opportunity to learn new strategies from experts for approaching standardisation and validation issues. Additionally, this programme was designed to boost the confidence of stu-
dents and honing their ability to collaborate as well as guide them to resolve laboratoryrelated issues with their colleagues. Experts present at the event included Dr Sushil Shah, Founder Chairman and Executive Director, Metropolis Healthcare; Dr Carman Wiley,
President, American Association of Clinical Chemistry (AACC); Dr Qing Meng, Director, Clinical Chemistry, University of Texas and MD, Anderson Cancer Center, Houston, TX; Dr Lakshmi Ramanathan, Chief Clinical Chemistry Service, Memorial Sloan- Kethering Cancer Center, New York;
Dr Ravender Singh, Co-Director of Endocrine Laboratory, Mayo Clinic, Rochester, MN; Dr Arnab Pal, Additional Professor, Biochemistry, PGI, Chandigarh; Dr Robert Rej, Associate Professor, Biomedical Sciences, School of Public Health, State University of New York, Albany; Dr Santosh Shetty, CEO & Executive Director, Kokilaben Hospital, Mumbai and more. The event began with Dr Barnali Das, Organising Secretary and Chair, AACC India section speaking about the vision of this CME. She informed that the AACC has been working towards improving education among biochemistry students and aims to further enhance clinical diagnostics. The experts present at the meeting pointed out that lab medicine has transformed from being restricted to clinical reports to becoming partners in decision making for healthcare provision. Diagnostics has truly evolved from the bench to the bedside. They informed that labs have to be in constant communication with the clinicians in order to provide quality diagnostics. Moreover, clinical biologists have become an important link in the entire healthcare provision system. Experts also shared insights on how total lab automation can reduce operating and labour costs and ensure a decent ROIs. However, they also highlighted that total lab automation needs constant monitoring as small failures or technical glitches can be detrimental to outcomes. Also, not all labs require automation. Only those with high volumes should resort to total automation. Dr Ramanathan advised some labs to avoid resorting to total lab automation as it is always better to have some human intervention in the process. She emphasised that some human control is a must. Additionally, experts deliberated on the significance of eliminating immunoassay interferences and address chal-
ABOUTAACC INDIA AACC India Section was established as a first international pilot project of American Association of Clinical Chemistry (AACC), in the year 2018. Its objective is to connect with global leaders in clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, laboratory management and other frontier areas of laboratory medicine. lenges associated with improving quality. Dr Reg highlighted the role of proficiency testing
and urged laboratories to opt for External Quality Assessment ( EQA )schemes. In re-
sponse to that, many Indian lab clinicians expressed the challenges associated with the ef-
fectiveness of lab quality management systems that are a hindrance to opting for EQA schemes. Nevertheless, most labs in India have opted for EQA schemes on a quarterly and half yearly basis, experts informed. At the end, all the experts were unanimous in expressing their dedication towards continuous improvement of lab practices to build a strong healthcare system in the country.
EXPRESS DIAGNOSTICS
13
November 2019
COVER STORY
14
EXPRESS DIAGNOSTICS
November 2019
The concept of big data, which has risen manifolds in recent years, is going to be a turning point for the diagnostics sector By Sanjiv Das
EXPRESS DIAGNOSTICS
15
November 2019
COVER STORY
W
orldover, diagnostics has been instrumental in generating huge data that can be analysed for clinical research and drug discoveries. As the sector continues to increase its focus on generating genetics and genetic mutation data, protein therapeutics data and designing personalised medicines, more and more of this information will be harvested to improve daily healthcare processes and solve complex health problems. Therefore, in the future, diagnostics is poised to become the biggest source for big data analystics. In this article, we examine how big data has been utilised in the Indian diagnostic sector and what impact can be expected in the future.
The role of big data in Indian diangostics In India, the diagnostics sector sees immense promise in big data to fuel growth for industry and gain actionable insights for clinical use. Experts believe that big data will be extensively utilised in the field of molecular diagnostics and genomic testing, finding new pathways to treat complex medical conditions and in furthering new drug discoveries in India. Opines Dr Ravi Gaur, COO, Oncquest Labs, “Whenever we visit a doctor, generally he/she prescribes a series of diagnostic tests to figure out what is going on. Also, many times we undergo those tests without even getting conclusive results. Given that medical diagnostics is not an exact science, and often a diagnostic test is one result in a list of many such similar tests, the medical field is turning to big data for help. The concept of big data is based on the premise of mining a large database of similar data and comparing trends in that data to a case at hand. This can often assist the analysis of one patient’s case. Big data has been used for numerous studies but rarely for diagnostics. Of late, innovative thinking in
16
EXPRESS DIAGNOSTICS
November 2019
DR VAIDEHI JOBANPUTRA
DR RAVI GAUR
Chairperson, Advanced Genomics Institute and Laboratory Medicine
COO, Oncquest Labs
We need advanced computing and smarter approaches to derive meaningful and actionable insights
the signal processing and data mining field aims to change that. If medical diagnostics could achieve that same efficiency using big data, the treatment of a variety of illnesses and maladies would change dramatically.” According to Sanjeev Vashishta, MD and CEO, Pathkind Diagnostics, big data has huge relevance in diagnostics. It has changed the way we manage, analyse and leverage patients’ data to help them monitor their health, predict
untoward incidents related to health and also to improve the quality of life. Huge volume and variety of data cannot be handled by conventional methods. Data mining at times has proven to predict diagnostics in a better way. It reduces clinical and economic burden of healthcare. Various studies highlight that more than 400,000 applications are available to facilitate self-health monitoring and the number of apps are going only northwards. Needless to mention,
Systematic and integrative analysis of omics data in conjugation with healthcare analytics can help design better treatment strategies
these applications have to bank on big data to churn out useful information. Vashishta further explains that the ability to transform big data into actionable knowledge will disrupt at least three areas of medicineFirstly, machine learning will drastically improve the ability of healthcare professionals to establish a diagnosis and make prognostics predictions based on thousands of risks predictive variable rather than at present prognostic
modals based on a handful of variables like Acute Physiology and Chronic Health Evaluation (APACHE) score and Sequential Organ Failure Assessment (SOFA) score in the Intensive Care Unit. Better prediction would transform advanced care planning including optimum utilisation of costly ICU stay. Secondly, machine learning would also display much of the routine work that a radiologist or Histo-pathologist does at present, as they focus on
analysing patterns. Algorithms would make pattern recognition more accurate and faster besides being available 24*7 available rather than an eight hour shift and being as vigilant at 3 am as at 11 am and being available in here to inaccessible areas. Thirdly, algorithms will soon generate differential diagnostics, suggest high value test and reduce the over use of unnecessary tests. Further, experts speak about various segments of diagnostics that have potential to propel growth of big data.
Molecular diagnostics and genetics: A great source Dr Vaidehi Jobanputra, Chairperson, Advanced Genomics Institute and Laboratory Medicine says, “Big data is a core part of molecular and genomic technologies because each assay generates a massive amount of data. Often, we are looking for changes and patterns in a huge volume of data which is akin to 'searching a needle in a haystack'. So we need advanced computing and smarter approaches to derive meaningful and actionable insights. This is where the role of big data comes in.” Experts also point out that big data is furthering scope for disease management and precision medicine as well. Hinting that big data analytics becomes a major source for disease management too, Dr Abhik Banerjee, Lab Director, Chief of Quality & Senior Consultant- Pathology, Suraksha Diagnostic adds, “Laboratory data should assist the clinician in providing better care for patients. In cases of insulin dependent diabetes mellitus (IDDM), retrospective review of huge lab data may potentially guide the physician to take decisions about appropriate doses of insulin which will ensure best intended effect. Similarly “big data” of laboratories will give more power to clinicians to choose appropriate doses of anticancer drugs
DR ABHIK BANERJEE
DR RAVI GUPTA
Lab Director, Chief of Quality & Senior Consultant- Pathology, Suraksha Diagnostic
Chief Scientist Bioinformatics R&D, MedGenome Labs
High cost,possibility of unauthorised access and breach of confidentiality of patients’data,adequate training of supervisors are some of the areas of concern
for their patients with minimum side effects. Availability of big data with its rational management will definitely have a far reaching impact in the field of personalised medicine.”
More scope to precision medicine The availability of patient data through multiple platforms has presented an opportunity to combine and consolidate data for devising personalised treatments. Says Amit Ray, Manag-
ing Director, Data Analytics, Protiviti Member Firm for India, “The emergence of valuebased care has encouraged all healthcare stakeholders to work together towards eradicating certain high impact diseases such as diabetes and CVDs by using more and more data to drive better patient care at the lowest cost possible.” According to Dr Banerjee, In the era of targeted therapy and precision medicine, availability of big data with laborato-
While migrating from physical to a cloud infrastructure, it is crucial to use the right tools to reduce security breaches
ries will definitely give a momentum to researchers and scientists towards finding effective disease-specific and disease-modifying treatments. Hence big data will definitely be an integral part for research and innovation in therapeutic arenas in the near future.” Dr Jobanputra emphasises, “Big data and genomics provide great opportunity and mechanism to look at each patient uniquely instead of broadly or forcibly categoris-
ing them to the nearest disorder or syndrome. Thus, seemingly unrelated clinical conditions and phenotypes can be studied and correlated with their genotypes. Such correlations open new avenues for precision medicine.” The diagnostic industry has seen a shift from trial-and-error to targeted therapy for illnesses. According to Dr Ravi Gupta, Chief Scientist Bioinformatics R&D, MedGenome Labs, clinicians will have significantly more time to
EXPRESS DIAGNOSTICS
17
November 2019
COVER STORY spend treating patients and counselling them, than diagnosing a certain illness and coming to a conclusion. “With the help of big data ,we can understand how a person’s genetics, environment, and lifestyle can help determine the best approach to prevent or treat disease. This has specifically helped in medical oncology. Increasing use of NGS in diagnostic centres has greatly simplified sequencing and decreased the costs for generating whole genome sequence data. The cost of complete genome sequencing has come down substantially. NGS technology has resulted in an increased volume of biomedical data that comes from genomic and transcriptomic studies. Combining the genomic and transcriptomic data with proteomic and metabolomic data can greatly enhance our knowledge about the individual profile of a patient—an approach often ascribed as “individual, personalised or precision healthcare” says Dr Gaur. Systematic and integrative analysis of omics data in conjugation with healthcare analytics can help design better treatment strategies towards precision and personalised medicine. This might turn out to be a gamechanger in future medicine and health.” Adds Vashishta, “Today, huge quantum of patient data is generated and using advanced predictive analyses, this information has the potential to enable diagnosis, treatment, and prevention of disease at a highly personalised level.”
Big business opportunity Now from a business perspective also, the scope for big data in diagnostics is certainly wide. Many multinational tech gaints have already developing technologies backed by big data to tap the market and further invest in research. Vashista informs that Google has established a number of new businesses that
18
EXPRESS DIAGNOSTICS
November 2019
AMITRAY
SANJEEVVASHISHTA
Managing Director, Data Analytics, Protiviti Member Firm for India
MD and CEO, Pathkind Diagnostics
The biggest challenge to the optimal use of data is the lack of integration between the different systems that produce or compile data in a healthcare system
combine its big data capabilities with medical applications. The Google X research lab part of Google X Life Sciences is creating the baseline study with the goal to build a genomics database to facilitate early diagnosis and disease prevention. Google anticipates that this may become the world's biggest data base, to include all sorts of medical information and laboratory test data. Major IVD companies such as Beckman Coulter Diagnos-
tics, Qiagen, Roche, Illumina, and PerkinElmer are gung ho about big data. “Data is being shared and gene targets have been validated and included in either targeted tests or panels. Now laboratory professionals and clinicians need tools to make sense of the continuous stream of tests and targets. IVD companies in collaboration with established and new IT companies are responding to this need with a massive wave of IT tool acquisitions, alliances and collaborations.
Increased vigilance, security best practices, and the right technology can help healthcare organisations secure patient data
These IT tools are offered as standalone services and also integrated into test platforms”, informs Vashishta.
Roadblocks to future growth While industry leaders see a lot of scope for big data utilisation in diagnsotics, the biggest challenge at hand is integration and the lack of understanding among providers. The other challenges lie in the interpretation of astronomical data in a rapid, cost-
effective and meaningful manner. Unfortunately, all the data used to construct the image is not necessarily helpful in a diagnosis, reveal experts. A lot of it is useless to the task of diagnosing the patient’s condition. One of the major obstacles is that a large amount of data remains stored in various decentralised data servers that are inaccessible to researchers due to data protection laws. Dr Gaur mentions, “Heterogeneity of data is a big challenge in data analysis. The
huge size and highly heterogeneous nature of big data in healthcare renders it relatively less informative using conventional technologies. Advanced algorithms are required to implement machine learning and artificial intelligence approach for data analysis. A good knowledge of biology and IT is required to handle big data from biomedical research. Methods for big data management and analysis are being continuously developed. Storage, accuracy, correctness, consistency, relevancy, unified formats and security are some of the growing challenges. New technologies like blockchain can probably help in addressing cyber security issues and making patient data more secure.” Ray mentions, “The biggest challenge to the optimal use of data is the lack of integration between different systems that produce or compile data in a healthcare system. This usually produces different sets of data for the same patient and discrepancy is usually found.”
Mitigating roadblocks Despite considerable advancements on the data analytics side, there are huge challenges, says Vashishta. Nevertheless, these roadblocks came be overcomed with smarter technologies and right strategies. Vashishta further explains, “In the Indian context, we still don’t have a common repository for patient data. In view of the fact that healthcare is still managed substantially by the unorganised sector, not many service providers are able to maintain patient records electronically. As a first step, we need to start registering patient data and then gradually link the same with a centralised repository system, access to which should be given to the service providers in the private, philanthropic and government space. This would help in better outcomes.” Dr Gupta adds, “While migrating from physical to a cloud infrastructure, it is cru-
WELL DEFINED ALGORITHMS WILL BE DRIVEN BY SCIENTIFIC DATA PRODUCED BY THE DIAGNSOTICS SECTOR. ARTIFICIAL INTELLIGENCE AND AUGMENTED INTELLIGENCE WILL HELP IN ARRIVING AT FINER AND PRECISE DIAGNOSIS. THEREFORE, BIG DATA ANALYTICS WILL CONTINUE TO AID IN THERAPY MONITORING, DISEASE PROGNOSIS, HEREDITARY RISK ASSESSMENT AND DISEASE SURVEILLANCE
cial to use the right tools to reduce security breaches. Limiting network access and controlling physical access and developing strategies to ensure safety can help protect sensitive patient data. However, there is a need for more enhanced patient data security and privacy guidelines in the Indian sub-continent as well.” Dr Banerjee, warns, “Unauthorised access to patient data might be detrimental. Unique ID, password-enabled LIMS, certified cloud based applications, document control, face recognition or finger imprint
capture facility of user are some of the security measures used by reputed laboratories in and outside India.”
What the future beholds? In future, digital transformation holds the key to success. Well defined algorithms will be driven by scientific data produced by the diagnsotics sector. Artificial intelligence and augmented intelligence will help in arriving at finer and precise diagnosis. Therefore, big data analytics will continue to aid in therapy monitoring, disease prognosis, hereditary
risk assessment and disease surveillance. Dr Gupta mentions, “We feel that there are enough opportunities for diagnostic players to collaborate with the government and private companies on causes that will ease the burden on the healthcare ecosystem of the country. Aggregating, integrating patient data and applying big data analytical techniques will help in developing better models which will enable the doctors in making better clinical decisions. Further, analysing big data from patients will
enable diagnostics service providers in developing newer solutions including developing screening programmes for various diseases that will benefit the masses.” Dr Jobanputra states, “Diagnostic organisations need to define their area of focus and expertise. A lot of technology is available off the shelf, but technology should not be confused with expertise.” Dr Vashishta sums up, “Big data could play a pivotal role in building scenarios that would help standardising protocols to handle some of the basic protocols and also help paramedics to take informed calls in remote areas where there is dearth of doctors/ specialists.” As rightly pointed out by experts, big data does hold the key to success for the diagnsotic sector in India. It has tremendous potential to improve healthcare. But the question of appropriate intregration still remains unanswered. The industry must work on educating healthcare providers on the proper intepretation and integration of big data. Also, the industry will need to address challenges associated with data privacy, security, ownership, and governance in future. sanjiv.das@expressindia.com
EXPRESS DIAGNOSTICS
19
November 2019
STRATEGY
Aster Labs: The new baby on the block Aster DM Healthcare has taken another winning leap by introducing Aster Labs. With this new venture, Aster aims to create a consortium of care for India and earn maximum market share in Indian healthcare By Raelene Kambli
F
ew international hospital groups have been able to dominate the India healthcare market so far. While most international groups have been expanding services by way of mergers and acquisitions, they have yet not made the right impact on the Indian population. However, Aster DM Healthcare has been an exception. The group saw the potential of the healthcare market in India and devised the right strategy to penetrate and expand its services. Today, it is one among the top 10 healthcare conglomerates in the country. Aster DM Healthcare, starting from a single clinic in Bur Dubai in 1987, is now recognised as one of the largest private healthcare providers operating in multiple Gulf Cooperation Council (GCC ) states, Jordan, Philippines and India through its network of 25 hospitals, 116 clinics and 238 pharmacies. The group currently has 4794 beds (majority in India with 3693 beds) across 13 hospitals in India and 12 hospitals in the Middle East. It is planning to add 600 beds in Bengaluru, 500 in Chennai and 60 in Kolhapur. Besides this, there are plans to set up a new 600-bedded multi-speciality hospital in Thiruvananthapuram. Aster also went IPO last year and got a decent response from the market. Now taking another winning leap, the group is all set to introduce Aster Labs based on the hub and spoke model. Aster has earmarked Rs 40 crore as a part of the initial outlay and seems bullish on this new vertical.
20 EXPRESS DIAGNOSTICS November 2019
They would be setting up their centralised pathology lab processing facility in Bengaluru, along with a satellite lab in the initial stages. By the end of 2020, Aster is aiming to launch one reference lab, eight satellite labs and 13 patient experience centres – mainly in the states of Karnataka and Kerala. The whole idea is to launch the centre where they have a stronger presence through local hospitals. By 2021, the hub and spoke model will be extended to other Southern states — Andhra
Pradesh, Telangana, Tamil Nadu and also in Western India - Maharashtra.
The value of diagnostics for Aster “India has around 100,000 diagnostic laboratories with an estimated Rs 60,000 croreplus revenues generated annually, which includes pathology laboratories and radiology centres. Also, diagnostics industry has a significant part to play in the overall healthcare sector. With an aim to cater to some of the service gaps in
healthcare delivery in India, we would be expanding our range of services. Our focus is to bring quality healthcare closer to the people. Also, today people have become more aware and conscious about their health and fitness. Continuous monitoring of BP, pulse reading, online health reports and predictions, maintaining a good lifestyle etc., have come in, thus giving diagnostics industry a boost. Lifestyle diseases in India are growing at a rapid pace and preventive healthcare is the only solution to it. Having said that, the industry is quite unorganised in India and the new entrant in this space has to be quite different from the rest and offer standardised services,” says Dr Azad Moopen, Founder CMD, Aster DM Healthcare while speaking about the positive outlook he has for the diagnostics sector. Dr Moopen has a point here. India's diagnostics sector is fragmented and traditional business models have started to stagnate. In such a scenerio, how will Aster prove themselves to be different? And, how will this new business add value to Aster's existing business in healthcare? “Unlike the traditional ‘just screening’ model, we would be focusing more on preventive healthcare and extending the service to the homes of our customers through proper logistic arrangements. With only five per cent organised businesses in the area of diagnostics in India, we think there is a significant opportunity for consolidation. We want to build an efficient clinical testing network through a refer-
ence laboratory and hub and spoke model to ensure specimen integrity and quick turnaround times from the satellite laboratory and patient experience centres. With significant investment for the next two years, we will have a centralised pathology lab processing facility in Bengaluru by 2020,” informs Dr Moopen. While the group has invariably focussed on accessibility of healthcare in regions where access is meagre, this new business vertical is a step to reinforce the same vision. “We are moving one step closer to people by extending our healthcare services to the homes of our customers, in terms of diagnostics through logistic arrangement. We have been consistent in our mission to provide quality healthcare and ensure accessibility. With Aster Laboratories, we want to set a benchmark for strict control measures and errorfree and highest quality results with lesser turn-around time,” Dr Moopen imparts. Aster is in the process of rolling its homecare as well as online consultation in a big way in India and GCC. The setting up of the laboratory vertical with home pick up services will add value to their businesses making them much more efficient and patient friendly. “The requirement of patients to come to clinics for even a primary consultation can be avoided if there is a robust telemedicine service where our large number of qualified doctors can provide benefit of consultation sitting at their homes. This will reduce the cost of healthcare
and will be less time consuming. Also, as a responsible healthcare player, we want preventive healthcare to be at the forefront. This is a global phenomenon where healthcare players are moving towards prevention of diseases rather than just treatment. This would only be possible by giving diagnostics the required push,� he conveys.
How will this boost the company's profitability? According to Dr Moopen, Aster Laboratories will be able to provide holistic range of services through hospitals, clinics, pharmacies and now diagnostics. He feels that this would be more of an evolved healthcare model offering preventive and curative healthcare. “State-of-the-art technology at our centres and the timely diagnosis will help address the critical healthcare challenges of the country. Unlike standalone pathology services, we have the advantage of
having a large number of hospitals and clinics where a lab is already functional. We send out many samples for advance testing to external laboratories which can be directed to our own referral lab. Moreover, the consolidation of the back-end will provide significant savings in consumables as well as manpower. These are likely to improve our existing margins,� Dr Moopen sanguinely states. Dr Moopen further has some investment plans for Aster Labs in future. He informs that the company will require more capital as they plan to add 20 centres every year covering more geographies. Additionally, the company will be looking at acquiring local pathlabs and its chains as a part of their strategic growth plan. So far, Aster's growth strategy seems to be clearly defined, however, the market is very competitive. With increasing demand for diagnostics services, the competition will get tougher. The group has
LAB DIAGNOSTIC'S POTENTIAL IN INDIA L
ab diagnostics is increasingly becoming a prominent and profitable business segment in India. According to a research report, 'Indian Diagnostic Services Market Outlook 2020,' the diagnostics services market is expected to grow at a CAGR of 27.5 per cent for the next five years. As per data released by the Department of Industrial Policy and Promotion (DIPP), hospitals and diagnostics centres have already attracted Foreign Direct Investment (FDI) worth $6.09 billion between April 2000 and March 2019. In keeping with this,various industry analysts and research experts inform that the lab diagnostics sector in particular will see more funds flowing in. Growth in this sector will be mainly driven by improved healthcare facilities in the country, heightened volumes of medical diagnosis and increased number of pathological laboratories, private-public projects and the health insurance sector. Moreover, with increased public health awareness and the rising burden of chronic diseases, this market will swell to approximately Rs 860 billion by 2020.
a strong base in southern India and is slowly venturing into the western region. Aster Labs will certainly have the advantage of a brand equity earned by the parent company in the southern states. But the challenge may lie in northern and western region where the market already has a strong network of regional and multistate players such as Dr Lal Pathlabs, SRL and Dr Dangs in Delhi and NCR and Metropolis
Healthcare and Suburban Diagnostics in Maharashtra and Gujarat. Here Aster will need to offer a great value proposition for their customers to penetrate the market and create brand loyalty. All of this also reflects that the diagnostics sector is set to see some exciting developments. More organised players entering the market will discipline the sector and create more access for quality diag-
nostic services. But the question of cost and affordability will still continue to haunt patients and providers both. Will these organised players manage to balance cost, quality and patient experience in future? Will affordable pricing, high quality services and good experience be part of Aster Labs value proposition for its customers? raelene.kambli@expressindia.com
EXPRESS DIAGNOSTICS
21
November 2019
LAB IN FOCUS
Dr Dangs Lab: 'Creating Value not Volumes' The lab strives for best patient care through efficient, effective and robust quality systems as the building block to a successful business is a happy and satisfied customer Prabhat Prakash
D
r Dangs Lab is revered as the go to lab for all diagnostics needs for patients as well as hospitals in the Delhi NCR region. The lab started operations in 1983 by founding members Prof (Dr) Navin Dang and Dr Manju Dang. The journey began with a small financial investment and a 400 sq ft area and today the facility stands at 30,000 sq ft specialised laboratory that doyens in the healthcare field swear by. Currently, the lab is run by the Dang family. The core members being Prof (Dr) Navin Dang, Dr Manju Dang, Dr Manavi Dang and Dr Arjun Dang. So whats the secret behind their success? Dr Navin proudly says, “Our focus on quality over quantity.” Being a NABL accredited lab, it follows the highest degrees of quality as well as services. The lab strives to provide best patient care and offers a large array of tests as per the needs of patients and hospitals alike. The lab tirelessly provides accurate test results, with shorter turnaround time to help patients as well as empower physicians to take informed decisions on clinical aspects, and directing them to provide effective treatment.
Services offered The lab offers a wide menu of tests in biochemistry, haematology including flowcytometry, microbiology, molecular biology, immunology, histopathology, and cytology. Along with its wide array of tests, the lab’s molecular laboratory routinely performs a wide array of infectious disease testing on the Roche
22
EXPRESS DIAGNOSTICS
November 2019
thermo cycler, Cobas taqman, Genxprt, and Hybribio. At Dr Dangs Lab, extensive leukaemia and MRD related testing is performed on the BD FACS flow cytometer in the department of specialised haematology. In an endeavour to make MRD assay feasible and available to children suffering from Acute lymphoblastic leukaemia (ALL ), Dr Dangs Lab along with Cankids offers the MRD assay to clinicians across the country. As a part of this project, the lab has performed close to 1000 MRD cases over the past one and half years. In view of the overwhelming response from the clinicians, the lab hopes to make the assay available for every patient suffering from ALL and thus facilitate treatment of
international standards. The lab plays an integral role in all lab processes including phlebotomy and other pre and post-analytical processes. It is a paediatric sensitised lab with special paediatric phlebotomists and pathologists trained in paediatric sample reporting along with the best doctors with specialist pathologists for MRD and haematoonco pathology. Preservation of integrity of samples from external centres and home collections is maintained by the lab’s elite home collection services, where samples are exclusively transported post centrifugation and bar-coding in air conditioned cars with provisions of monitoring and maintaining the cold chain with temperature data loggers.
In the words of Dr Navin Dang, “Today, Dr Dangs Lab is the only lab in India that has a mix of unparalleled report quality, personalised attention to patients, ethical work ideals and the highest repute in the doctor community.”
Automation enhancing productivity and quality Automation is a crucial part of a diagnostics lab in today's day and age as it reduces Turnaround Time (TAT), is precise and accurate, and eliminates the chances of human errors.
Dr Dang's lab too has opted for automation to ensure better efficiency in operations and higher quality outcomes. From sample life cycle to collection to dispatch of reports everything is automated in the lab. There are robust checks incorporated in the automated workflow to ensure the highest diagnostic accuracy and reliability of services that are provided. Some of the automation tools include the use of pneumatic chutes for timely transfer of biological specimens to the lab for analysis, FDA approved/CE marked automated platforms and use of a robust Laboratory Information Management System (LIMS) to effectively manage samples and associated data. The lab has high throughput, integrated and modular clinical chemistry, and immunochemistry analysers that are interphased to LIMS for direct electronic transcription of test results, eliminating even the slightest chance of errors due to manual intervention. Samples are bi-directionally barcoded through LIMS, which a major component of automation, which enables the barcoded information on the collection tubes to be accurately read by analysers. The barcodes which are generated at the time of registration or sample collection itself where in tests are punched along with demographic details. The lab puts in a lot of effort to improve patient care through accuracy and consistency in laboratory analyses. Dr Arjun Dang is of the opinion that the future will be strongly backed by automation and digital technologies that will enable pathology into becoming more efficient and more scalable field in medical sciences.
Quality control and quality assurance The lab takes great pride in providing the highest degrees of service and quality results. The laboratory is known for consistent quality driven operations through the systematic
implementation of effective quality management systems (QMS) that assures clients (patients pan India and hospitals like HAHC Hospital, SGT medical college & Hospital, SITARAM Bhartiya Hospital, Aashlok Hospital etc.) of accurate, reliable and timely reporting of test results. The lab strives for best patient care through efficient, effective and robust quality systems. The laboratory subjects itself to continuous and rigorous voluntary accreditation compliant to global ISO 15189 standards applicable to clinical laboratories through demonstrated competence to achieve quality goals. A dedicated QAU (Quality Assurance Unit) is setup to help design, implement and continually improve on the laboratory’s performance and services. Dr Arjun Dang states, “We understand that discrepant laboratory results may pose considerable risk to patients and hence, make all possible structured efforts including multiple internal and external laboratory quality control and quality assurance (qc/qa) measures, participation in proficiency testing (pt). Proficiency testing determines the performance of individual laboratories for specific tests or measurements and is used to monitor laboratories continuing performance. Proficiency testing involves a group of laboratories or analysts performing the same analysis on the same samples and comparing results. The key requirements of such comparisons are that the samples are homogeneous and stable and also that the set of samples analysed are appropriate to test and display similarities and differences in results. The lab is committed to performing proficiency testing on a regular basis to ensure the best quality of our services. The lab also ensures that a triple quality check, involving the sample being seen by a MD pathologist, quality manger and one from the lab as well. “We have managed to main-
tain our above par quality standards by always having a significant number of doctors (MD pathology) in our manpower count as well as employing a unique Triple Quality Check which ensures a no error patient report,” mentions Dr Arjun Dang. “Maintaining and surpassing quality is an ongoing process and we at Dr Dangs Lab are never satisfied with the status quo .We continuously strive towards increasing our test menu, ensuring that our equipment is at any time the best in class as per global standards, hiring newer talent and holding rigorous trainings as well as improving on the customer interface experience, whilst never deviating from our core goal of providing the most accurate test results” adds Dr Arjun Dang.
Biomedical waste management According to Dr Dang, their lab is one of the first labs across India to adhere Biomedical waste Management Guidelines 2016 completely, in terms of barcoding of waste at the point of generation that allows live tracking of waste generated daily, through automated system.
Measuring success The success of this lab is mainly measured in terms of the goodwill it has earned in so many years. Although the lab chain has been performing well in the northern states, Dr Dang and his team is overwhelmed with the trust his laboratories have earned. Dr Arjun Dang states, ''Our motto has always being, 'Creating Value not Volumes'. This has led to an unparalleled ethos with the Dr Dangs family at the helm of affairs who strongly believe that every sample is a patient and deserves the best attention and care. A satisfied patient is what has been and will be the cornerstone of measuring success for this lab. prabhat.prakash@expressindia.com
EXPRESS DIAGNOSTICS
23
November 2019
CANCER CARE
Vanquishing cancer with genomics Dr Siddharth Srivastava, Chief Scientist (Molecular Oncology), Neuberg Center of Genomic Medicine elaborates on how genomics has changed the way cancer diagnosis and treatment is perceived
P
recision medicine, personalised medicine, targeted drugs, next-generation sequencing and many more words are used frequently when people talk about cancer treatment. What exactly they mean and how DNA analysis of tumour is changing the way cancer is perceived and treated. To understand the whole story, let’s imagine a normal cell about to
become cancerous. A normal cell multiples from one to two when it gets a growth signal usually from adjacent cells. These growth signals are small proteins that bind to the receptors on the surface of this particular cell. Upon binding to the receptor, the receptor protein changes its conformation and relays the signal to a specific signalling protein nearby. Let’s name it as sig-
Following are some of the examples in brief: Colorectal cancer (CRC) RAS and BRAF mutations are of prognostic and predictive value in metastatic CRC. Pathogenic mutations in KRAS at amino acid positions 12 and 13 are involved in 12-75 per cent of CRC tumours. These mutations are also associated with worse prognosis in CRC (1). BRAF V600E mutation is detected in less than 10 per cent cases of CRCs and it is strongly negative prognostic marker for metastatic CRCs (2). However, the negative affect of BRAF V600E isn’t significant if the tumour is microsatellite instable (MSIhigh). Thus a comprehensive assessment of KRAS, NRAS, BRAF and MSI becomes crucial to understand prognosis and treatment options for CRC patients. A diagram of the decision tree is depicted alongside.
24 EXPRESS DIAGNOSTICS November 2019
nalling protein one. Signalling protein one triggers signalling protein two, which may trigger signalling protein three. The last signalling protein in the chain enters nucleus and sits over specific and marked portions of the DNA inside. This act allows specific genes in the nucleus to transcribe and translate new proteins which tell our cells to divide. Thus, an external growth signal trig-
gers a relay race of signalling proteins leading to growth and multiplication of cells. Off course this process must be tightly regulated else the cells would keep on dividing and end up in a large mass called tumour. Each of these signalling proteins are coded by genes. Genes are coded by four letters, A, T, G and C. Let’s imagine signalling protein two is coded by a ten letter long
gene ATGCGATGCT. Unfortunately, our cell was residing in the lungs of a person who was a chain smoker. Through mechanisms unknown, the fourth letter of the gene changed from 'C' to a 'T'. While this difference may seem very small, it made a big difference in the way signalling protein two behaved. Earlier signalling protein two needed a signal from signalling protein one to in turn trigger signalling protein three. However, with a change in the 4th letter, even without a signal from upstream, signalling protein two can trigger the protein downstream of it and that too, continuously. Of course, the cell is constantly stimulated and it keeps dividing. In effect the cell has lost regulation over its own growth that leads to tumour formation. When a signalling protein gets mutated and causes cancer, they are called oncoprotein and the genes that were mutated are termed oncogenes. EGFR and KRAS are few such oncogenes and pathogenic mutations in those lead to NSCLC type of lung cancer. On the other hand, a group of proteins act as guards to the process that allows the cell to proceed for cell cycle and eventually multiply from one cell into two. P53 is one such example. If a mutation occurs in the gene TP53 that codes for protein P53 such that now P53 is rendered useless, the cell will continuously go into cell cycle and multiply into a tumour. Such genes are called tumour suppressor genes. We have stated the mechanism or oncogenes and tumour suppressor genes in a simplistic fashion. More molecular mechanisms that may make a cell cancerous, exists. For e.g. aberrations in DNA repair. The knowledge that cancer is caused by specific mutations in genes led to large efforts to catalogue such mutations. The Cancer Genome Atlas https://cancergenome.nih.gov/, International Cancer Genome Consor-
Agent
Target(s)
FDA-approved indication(s)
Afatinib (Gilotrif)
EGFR (HER1/ERBB1), HER2 (ERBB2/neu)
▲ Non-small cell lung cancer (with EGFR exon 19 deletions or exon 21 substitution (L858R) mutations)
Alectinib (Alecensa)
ALK
▲ Non-small cell lung cancer (with ALK fusion)
Atezolizumab (Tecentriq)
PD-L1
▲ Non-small cell lung cancer
Brigatinib (Alunbrig)
ALK
▲ Non-small cell lung cancer (ALK+)
Ceritinib (Zykadia)
ALK
▲ Non-small cell lung cancer (with ALK fusion)
Crizotinib (Xalkori)
ALK, MET, ROS1
▲ Non-small cell lung cancer (with ALK fusion or ROS1 gene alteration)
Dabrafenib (Tafinlar)
BRAF
▲ Non-small cell lung cancer (with BRAFV600E mutations)
Erlotinib (Tarceva)
EGFR (HER1/ERBB1)
▲ Non-small cell lung cancer (with EGFR exon 19 deletions or exon 21 substitution (L858R) mutation)
Gefitinib (Iressa)
EGFR (HER1/ERBB1)
▲ Non-small cell lung cancer (with EGFR exon 19 deletions or exon 21 substitution (L858R) mutations)
Necitumumab (Portrazza)
EGFR (HER1/ERBB1)
▲ Squamous non-small cell lung cancer
Osimertinib (Tagrisso)
EGFR
▲ Non-small cell lung cancer (with EGFR T790M mutation)
Trametinib (Mekinist)
MEK
▲ Non-small cell lung cancer (with BRAFV600E mutation)
NON SMALL CELL LUNG CARCINOMA (NSCLC) There are two main classifications of lung cancer: small cell lung cancer and non-small cell lung cancer (NSCLC). Both types of cancers are treated differently. NSCLC begins in the epithelial cells. Adenocarcinoma starts in cells that produce mucus. Many receptor tyrosine kinases such as EGFR, ERBB2 are classified as oncogenes for NSCLC adenocarcinoma. Also, proteins of MAPkinase pathway such as KRAS and BRAF act as oncogenes for NSCLC adenocarcinoma. Many targeted therapies are already US FDA approved for patients identified with one of the pathogenic mutations in these oncogenes.A diagram of the decision tree and current list of approved targeted therapies are depicted in
tium http://icgc.org/ are few examples. Such international efforts are describing landscape of mutations across the entire human genome and correlate them to specific cancer types. This knowledge also triggered efforts from biotechnology and pharmaceutical companies which are devising new molecules every month that targets oncoproteins. These drugs are popularly called targeted therapies as the drugs target very specific protein molecules. Gefitinib (Iressa), Imatinib, Alectinib,
Crizotinib are few examples. Let’s say if signalling protein two was mutated and caused continuous relaying to growth signal to cause cancer, oncologist would use a targeted therapy that specifically attacked and neutralise signalling protein two. However, such targeted therapy would not affect any other protein. Thus, to choose a targeted therapy, it is imperative to understand which protein is causing cancer and to do that, one needs to know which gene is mutated. Thus, unlike chemother-
TO CHOOSE A TARGETED THERAPY, IT IS IMPERATIVE TO UNDERSTAND WHICH PROTEIN IS CAUSING CANCER AND TO DO THAT, ONE NEEDS TO KNOW WHICH GENE IS MUTATED
EXPRESS DIAGNOSTICS
25
November 2019
CANCER CARE apy where much of the choice and regimen of treatment relied upon the clinical presentation and histopathology of the patient, targeted therapy could be chosen only if the oncologist knew which protein is causing cancer. This opened entirely new disciplines of molecular diagnostics and molecular pathology. Molecular diagnostics deal with a gamut of technology focussed on extracting tumour DNA and reading it. Since the tissue samples are limiting, laboratories use PCR to amplify tiny DNA signals. These amplified DNA are then read using Sanger method, Next Generation Sequencing method or by droplet digital PCRs. Final goal of molecular diagnostics is to read the tumour DNA and compare it with healthy tissue. The differences reveal critical characteristics of the cancer which is exploited by an oncologist to determine treatment and prognosis of the patient. The advent of molecular biology in cancer diagnosis and treatment has opened up requirement of molecular pathologists. Currently PhDs researching in pathology at molecular level, understand cancer pathology, cell biology and molecular biology. Based on molecular (DNA, RNA and proteins) differences between tumour cells and normal cells, molecular pathologists make recommendations to an oncologist in a fashion similar to a histo-pathologist.
References: 1. Porru M, Pompili L, Caruso C, Biroccio A, Leonetti C. Targeting KRAS in metastatic colorectal cancer: current strategies and emerging opportunities. J Exp Clin Cancer Res. 2018;37(1):57. Published 2018 Mar 13. doi:10.1186/s13046-018-0719-1 2. Ursem C, Atreya CE, Van Loon K. Emerging treatment options for BRAF-mutant colorectal cancer. Gastrointest Cancer. 2018;8:13–23. doi:10.2147/GICTT.S125940
26 EXPRESS DIAGNOSTICS November 2019