2019 / Vol.8/ Issue-1
www.insightscare.com
The
BEST
MEDICAL&
CLINICAL
LABORATORIES To Watch For 2019
Techadvancements Gearing the Future of Laboratories
S
ince many decades, medical devices have been growing smaller, inexpensive, and more portable. The point-ofcare tests that are tested external to the traditional laboratory are extensively used for monitoring blood glucose in diabetes, pregnancy testing, and for many other applications.
Today, medical testing is experiencing another altering phase where recent technological advances are enabling the development of tests that make medical screening, diagnosis, and monitoring less confined, more low-cost, and patient-focused. Few of these devices are next-generation point-of-care devices while others provide individuals with unprecedented genetic information. New and emerging medical tests have the potential to deliver the kind of patient-centered as well as evidence-based medicine that consumers and healthcare professionals have been expecting. One of those examples can be the situation for the people having diabetes. Pricking their fingers to draw blood and then test the blood in a glucose monitoring machine can be a tedious process. Sometimes it means that diabetics don’t test their glucose as frequent as they should. Plus, the method doesn’t provide the big picture of how an individual’s glucose levels change throughout the day and night. However, continuous glucose monitoring (CGM) offers a solution for substituting the finger prick method and these systems rely on a small sensor placed under the skin and a data receiver. Further progresses showcases that concept a step further by providing efficient CGM that is compatible with a smart watch. A prime benefit of the device is that people can track their glucose data and this is how parents can make a precise record of their loved ones health from far. Truly, this is an exciting time for medical testing, but there are various considerations for these evolving technologies. Also, data privacy is a primary concern as consumers and their healthcare providers become more flooded in personal medical information. New testing devices are best used along with professional consultation to ensure you aren’t making decisions that could compromise their health. Advanced testing technologies are still complimentary to traditional laboratory testing. While many of the tests are in their early days, they promises us of moving closer to a complete individualized, less confined, and patient-centric medicine.
Ashwini S. Deshpande, Editor
Bes t
1 T H E
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
The Backbone of the Healthcare Industry
H
ealth is one of the major concerns in a person’s life. A person rushes to the hospital or a clinic when there is any kind of health issue and he is assured that he will be treated there and will return home healthy. But, a doctor cannot give confirmation of what a patient is suffering through, unless he gets the clinical reports of the specimens of the patients. Hence, medical and clinical laboratories play a vital role in accurately diagnosing a disease the patient is suffering from. With the advancements in technology, new methodologies and high-end types of equipment are emerging that are aiding for better and error-free diagnosis. This has impacted the healthcare industry like never before. Various companies are now using this as an opportunity for the betterment of the people. In this edition of “The 10 Best Medical & Clinical Laboratories to watch for 2019” we are showcasing the companies that have paved their way innovation through uniqueness. In this issue of Insightscare, we have featured Aspenti HealthTM, a diagnostic and digital health company designed to address population health for substance use management; Diamond Medical Laboratory, a prominent laboratory that delivers high quality and cost-effective care through its highly trained professional staff; DNAfit, a renowned customized health and wellness company using genetic science to improve health outlook for millions of people; San Diego Reference Laboratory (SDRL), a full service, client-focused analytical biomedical testing laboratory that delivers comprehensive clinical and drug testing toxicology services; Covance; Northeast Laboratory Services; MedLabs; PGD Labs; Proficiency Healthcare Diagnostics; and Serosep Diagnostic. Additionally, we have also highlighted the story of SCL Healthcare Central Laboratory in an exclusive interview with its CEO, Kyoung Ryul Lee. We have also incorporated an interesting article from our in-house editor. So, flip the pages and enjoy a good read!
Editor-in-Chief Pooja M. Bansal Senior Editor Anish Miller Managing Editor Ashwini S. Deshpande Executive Editor Aishwarya Nawandhar Visualiser David King Art & Design Head Amol Kamble Art & Design Assistant Poonam Mahajan Co-designer Paul Belin Art & Picture Editor Shweta Ambilwade Business Development Manager Peter Collins Marketing Manager Marry D'Souza Business Development Executive Mark williams Sales Executives Amy, John, Bill, Sarah Technical Head Jacob Smile Assistant Technical Head Pratiksha Patil Technical Consultants David, Robert Digital Marketing Manager Alina Sege Assistant Digital Marketing Manager Prashant Chevale SME-SMO Executives Manoj, Gemson, Uma Research Analyst Eric Smith Circulation Manager Tanaji
sales@insightscare.com
August, 2019 Corporate Ofces: Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - (614)-602-1754 Email: info@insightscare.com For Subscription: www.insightscare.com
Insights Success Media and Technology Pvt. Ltd. Ofce No. 22 & 510, Rainbow Plaza, Shivar Chowk, Pimple Saudagar, Pune, Maharashtra 411017 Phone - India: 7410033802, 74100058552 Email: info@insightscare.com For Subscription: www.insightscare.com
Copyright © 2019 Insights Success, All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights Success. Reprint rights remain solely with Insights Success.
Interview with insights success
10
SCL Healthcare Central Laboratory The Forefront of Research and Clinical Trial Studies in Korea
Article
16
Industry Trends Recent Advancements in Diagnostic Industry
Aspenti Health ™ Offering Diagnostic and Digital Health Solutions for Substance Use and Pain Management
20 Diamond Medical Laboratory Providing Unmatched Mobile Healthcare Services
24
DNAď€ t Personalizing Wellness with Cutting-edge DNA Tests
28 San Diego Reference Laboratory Committed to Better Living through Chemistry
32
SCL Healthcare
Central Laboratory The Forefront of Research and Clinical Trial Studies in Korea
H
ealthcare is moving from volume-based care to valuebased and with it, we can expect the clinical standards to rise and improve quality of life. Research and development of various medicines, therapeutics, and methodologies are not only taking us closer to achieving new milestones in healthcare, but also in revamping the efficiency and reliability of already existing techniques. A leading Korean company, that has been instrumental in carrying out research and development for various healthcare providers is SCL Healthcare Central Laboratory (SHC C-LAB). With three core values- Service, Quality and Research, SHC C-LAB has developed into the largest nationwide clinical laboratory and has acquired the reputation of best reference laboratory in Korea. SCL Healthcare Group is led by its CEO, Kyoung Ryul Lee, M.D., Ph.D. To understand more about the laboratory, its services, its journey through all these years, we bring to you an exclusive interview with Mr. Lee. He discusses, in detail, about the company, their future plans, and various other
10
/ August 2019 /
interesting aspects of the SHC C-LAB and the industry. 1. Kindly share in brief about SCL Healthcare Central Laboratory. Also, tell us about your vision and mission. SCL Healthcare Central Laboratory (SHC C-LAB) is the Korea’s first central Laboratory dedicated to clinical studies. We started central Laboratory business since 2006 as the first and largest central laboratory in Korea. We have been dedicating and carrying out our works in developing new drugs and clinical trials (phase I, II, III, IV), Investigator Initiated Trials (IIT), Sponsor Initiated Trials (SIT), and experiments for research papers. Our experts on clinical trials and experiments help researchers in all process from consultation to result reporting. We promote healthcare that will continue onto future generation by harmonizing the physical, mental and environmental states through consideration and respect
Kyoung Ryul Lee M.D., Ph.D, CEO
/ August 2019 /
11
2. Tell us something about the CEO/Founder/Director/MD of the laboratory. A CEO of SCL Healthcare Group, Kyoung Ryul Lee M.D., Ph.D is a medical doctor specialized in Laboratory Medicine. He graduated Yonsei University College of Medicine. He was a professor at Yonsei University. He became a CEO of SCL Healthcare Group in 2007. He emphasizes to maintain our three key values which are quality, service and R&D. He received the “Order of the Polar Star” from Mongolian government for the first time in field of medicine in 2009, because SCL Healthcare Group founded MOBIO diagnostic Medical Laboratory in Ulan Bator, Mongolia. He also received Global Leader Award from Global Community in 2017. He highlight that the SCL Healthcare Group will double our efforts to satisfy our clients, therefore we will be dedicated to becoming a truly patient-centered Central Laboratory that focuses on evidence-based medicine. 3. What influenced you to start a healthcare laboratory? Share with us your journey so far. As the advancement in new drugs development progresses more globally, the importance of a central laboratory business is being increasingly emphasized in Korea as it is in the United States and Europe. In order to meet these growing demands, SCL Healthcare, a pioneer in clinical diagnostics, established the Korea’s first central laboratory. 4. What was the turning point for SCL Healthcare Central Laboratory, according to you? As clinical trials have increased and customer’s needs have been
12
/ August 2019 /
diversified, I founded SCL Healthcare in 2010 by separating from SCL (Seoul Clinical Laboratories). In addition to the Central Laboratory, we have expanded our business to the Companion Bio-marker Center, Medical Diagnosis, and Bio Logistics. Since then, our clients have high satisfaction and we have currently the highest market share in the domestic Central Laboratory field. Through both quantitative and qualitative improvements, SHC CLAB will grow into a key global company. 5. What are the unique points/specialties of the laboratory? Tests performed in SHC C-LAB maintain continuity using validated methods. Test results are generally kept in storage until the application for new drug approval and for a longer period of time as requested by our customers. Since the process of developing new drugs takes long, it is usually desired that the same index is used during a clinical study. In order to meet the strict demands, we perform tests continuously with the same validated-test methods. By unifying reference ranges and eliminating deviations that may occur during the analysis of each site, we produces test results that are more easily interpreted and have continuity. In addition, SHC C-LAB reports test results with a data management process specialized for clinical studies and that allows fast and convenient bio-statistical analysis. 6. Apart from technology and applications, what are the other services and solutions that your lab provides?
SHC C-LAB puts unsurpassed resources, knowledge and experience in laboratory management to work for customers on each clinical study.
• • • • • • •
We provide experienced project management staff to support the high test level of quality. National and international communications Clinical study knowledge resources Risk management focus with a customer service Support for kits Remnant specimen storage Study data management Quality assurance
7. How advanced are your lab equipment? SCL Healthcare has state-of-the art equipment including the largest Laboratory Automation System (LAS) in Asia. We have optimal environment for central laboratory testing such as automatic ventilation, automatic temperature and humidity control system for all kinds of esoteric test items. 8. What critical measures do you take to ensure the safety of your employees in the lab? All employees wear a gown, gloves, and a mask when tests are performed and we have safety equipment such as eye wash station and emergency shower station. We also conduct safety management training once a month. 9. Being the key person of the company, one of the main responsibilities is to ensure that the needs of the clients are being met properly. How do you coordinate with your team members to guarantee client satisfaction? SCL Healthcare pursues field
Interview with Insights care management, speed management, and quality management as its management policy. In order to perform accurate test quickly and correctly, employees have ample opportunity and complete the necessary training. The company respects all employees and is committed to maintaining a good and safe working environment. In addition, in order to communicate with clients, staff members regularly visit clients and we develop and provide various tests for the diagnosis and research of diseases through professional academic activities. 10. Share with us the most spectacular client experiences? When we attended an international conference, one of the biggest CROs (Clinical Research Organizations) visited our booth and had a meeting. The company was interested in expanding its business in Asia including Korea, and was an opportunity to introduce our company and talk about possible areas for cooperation. The CRO’s executives then visited our laboratory in Korea, toured the facilities, and discussed specific partnerships. Currently, we are working collaboratively in many parts of domestic and overseas clinical trials, and SHC C-LAB are participating in the field of new drug development with pride as Korea’s representative Central Laboratory. 11. What are the awards and accolades your company has received so far? Certifications: • Acquired CAP (College of
•
•
•
•
•
•
•
•
•
•
American Pathologists) Certification in 1998 as Korea’s first Laboratory participated in CAP Certified NGSP (National Glycohemoglobin Standardization Program) Level 1 Laboratory every year Received ISBER (International Society for Biological and Environmental Repositories, USA) Acquired QMEQAS (CTQ/INSPQ external quality assessment scheme) Acquired CDC LSP (Centers for Disease Control and Prevention for Lipid Standardization Program) Acquired CDC Newborn (Centers for Disease Control and Prevention for Newborn Screening and Molecular Biology) Acquired CDC LAMP (Centers for Disease Control and Prevention for Lead and MultiElement Proficiency) Received CDC VDSCLP (CDC Vitamin D StandardizationCertification Program) as Asia first laboratory in 2015 Received G-EQUAS (German External Quality Assessment Scheme) Received ISO9001 quality management certification in Clinical Laboratory Acquired GCLP (Good Clinical Laboratory Practice) in 2019
12. What are your future goals? Also, tell us about the ongoing or upcoming projects your company could launch. Our long-term vision is to leap forward as a “Global Medical Company”. We plan to implement the strategy step by step such as establishing new business processes and expanding our global market share. With new paradigm of the medical environment in time of needs, SHC C-LAB will continue to present new business models for
AWARDS • 2017 Global Leader Award from Global Community • 2015 Grand Prize in Medical Asia 2015 • 2015 Ministry of Health and Welfare Award • 2014 Mongolia Ulaanbaatar Railway Service Medal • 2012 Seoul Mayor Award • 2011 Mongolian Ministry of Health, Mongolian Medical Pioneer Medal • 2009 Mongolian President, Arctic Medal • 2009 American Biographical Institute, Top 500 Influential People in the World • 2009 Korea Minister of Health, Welfare and Family Award • 2007 Stevie Award Iba Chief Executive Officer Finalist
customer satisfaction and patientcentered healthcare. 13. What advice would you give to the budding entrepreneurs in the industry? As clinical trials market is expanding and become more complex, the role of the central laboratory is becoming increasingly important. Only laboratories those are well aware of the trends of trials and can work with customer’s needs will be able to grow into a key player in the clinical trial market.
/ August 2019 /
13
16
/ August 2019 /
Industry Trends
T
he healthcare sector is moving from reactive care to preventive care. Preventive care helps the patient take necessary precautions to avoid certain conditions and also helps them in identifying the root of a disease before it becomes serious. Additionally, the cost of preventive care is much less than that of reactive care. Diagnostics is a major part of preventive care. All the conventional treatment methods mostly follow the trial and error method, where the illness is guessed based on the symptoms the patient shows. It is necessary to move ahead from this method to personalized care to improve the outcomes of healthcare. Optimum diagnosis is the first step towards this. The diagnostics industry is witnessing immense transformation and there are various new developments that are helping it move towards personalized care. Let's look at the recent devices transforming diagnostics.
Better Detection of Ebola Virus with a Microfluid Device Ebola is a highly contagious and deadly virus and once infected, it leaves limited treatment options for the patient. Moreover, it can spread easily and start an epidemic. To combat the dangers it brings to the human lives, scientists at the Rochester Institute of Technology (RIT) have developed the prototype of a novel micro device. This device helps diagnose the infection caused by Ebola early, which results in better treatment outcomes as well as reduces the spread of infections. The developed microfluid device has biosensors attached to it. It is a small, automated chip that has fluorescence sensors attached to it. The device detects the Ebola RNA when the patient's sample is added to it by activating the CRISPR mechanism. The researchers are further trying to find a way to generate this device at affordable costs. / August 2019 /
17
KidneyIntelXA Breakthrough Device
Q-POC – A Revolutionary Diagnostics Kit
18
/ August 2019 /
KidneyIntelX is the main diagnostic test for kidney diseases devised by Renalytix AI plc. It exhibits promise to improve the clinical management of patients with fast-growing kidney diseases and type-2 diabetes. It helps in better diagnosis and well as treatment of these. KidneyIntelX uses machine learning algorithms to examine the combination of predictive bloodbased biomarkers. These include sTNFR1, sTNFR2, and KIM1 along with the electronic health record data. The device is designed to identify the progressive kidney disease. It was designated as a Breakthrough Device by FDA.
KidneyIntelX is the main diagnostic test for kidney diseases devised by Renalytix AI plc. It exhibits promise to improve the clinical management of patients with fast-growing kidney diseases and type-2 diabetes. It helps in better diagnosis and well as treatment of these. KidneyIntelX uses machine learning algorithms to examine the combination of predictive bloodbased biomarkers. These include sTNFR1, sTNFR2, and KIM1 along with the electronic health record data. The device is designed to identify the progressive kidney disease. It was designated as a Breakthrough Device by FDA.
A Remarkable DNA Sequencing Device- MinION
MinION, a new DNA sequencing device by Oxford Nanopore, can detect the Huntington's disease a lot faster than the traditional ways. It could therefore drastically reduce the waiting time for number of critical cases of Huntington's disease, as well as other genetic disorders in the future. Moreover, it meets the strict international quality standards for laboratory use. MinION is a small device which decodes every DNA strand separately in real-time. This handheld device can then identify the changes in any DNA sequence to detect the genetic disorder. Being able to do all of this in real-time, the device cuts down the wait time for the results.
Mass SpecPromise of a Better Tomorrow
MinION, a new DNA sequencing device by Oxford Nanopore, can detect the Huntington's disease a lot faster than the traditional ways. It could therefore drastically reduce the waiting time for number of critical cases of Huntington's disease, as well as other genetic disorders in the future. Moreover, it meets the strict international quality standards for laboratory use. MinION is a small device which decodes every DNA strand separately in real-time. This handheld device can then identify the changes in any DNA sequence to detect the genetic disorder. Being able to do all of this in real-time, the device cuts down the wait time for the results.
The medical diagnostics industry is advancing at a fast-paced. The new innovations come with a promise to enhance the accuracy of detecting diseases in a human body in real-time. Moreover, the ease of use, simplicity in manufacturing as well as the affordability of the latest devices is improved. -Aishwarya / August 2019 /
19
Aspenti Health ™ Offering Diagnostic and Digital Health Solutions for Substance Use and Pain Management
A
spenti Health was established by a group of seasoned healthcare leaders who made a commitment to acquire a struggling toxicology lab in Burlington Vermont, three years ago. From the initial days, their vision was to leverage crucial lab data and supplement this vital information in addiction and care recovery with value services including software, health analytics, and leadingedge education. This paradigm shift for a lab, fueled by the opioid crisis and the broader impact that substance use disorder has on communities, families and personal friends, motivated them to innovate continuously and act differently than any other toxicology lab. Aspenti Health ™ is the first lab designed to address population health for substance use and pain management patient through diagnostic and digital health solutions. The Dedicated Duo Aspenti’s CEO, Chris Powell, is a dynamic personality who has over 30 years of enriched experience in healthcare. He started his career with IBM as field sales professional before moving to IDX Systems Corporation, which was acquired by GE Healthcare in 2006. There, Chris worked as the Vice President and General Manager of
20
/ August 2019 /
GE Healthcare Americas Commercial Healthcare IT business, including the United States, Canada, and Central and South America. Chris left GE in 2011 and went on to become CEO at Precyse, a Health Information management (HIM) company that led the healthcare transition to the ICD-10 coding set. Under Chris’ leadership and growth, Precyse was acquired to form nThrive, a healthcare revenue cycle and service company, before coming to Aspenti Health. Jill Warrington MD, PhD, is the Chief Medical Officer of the company has more than two decades of experience in the medical field with a focus on laboratory medicine and substance use care. She is passionate about the role that laboratories can play in optimizing clinical decision making and supporting clinical workflows. Her key areas of interest include driving appropriate utilization of testing services, integrating health analytics to inform care, and reducing administrative burden through automatization of unnecessary operational steps. Distinctive Services and Solutions Aspenti Health is a unique healthcare company in the substance use disorder (SUD) space. Being specifically designed to promote population health
for substance use and pain management patients, Aspenti is a state-of the art laboratory that leverages innovative methods for urine drug screening and confirmation testing with wrap-around technology and services. The company is changing the standard of care for SUD patients through Care Coordination, Population-specific Health Analytics, and Education. Aspenti’s Care Coordination tool, Aspenti Navigator a random testing engine schedules and notifies patients for random tested based on the frequency assigned. The company’s software solution alleviates the administrative strain of managing random testing. Aspenti Insights, powered by its advanced business analytics software and data analysts provides real time health analytics to help control costs and improve outcomes. Identifying the ability of population health analytics to support community partners and directly impact patient care, Aspenti has an internal health analytics team and a versatile custom business analytic tool. Using laboratory data, it has deep insights on emerging drug trends, treatment adherence, and the frequency of unexpected findings. Aspenti leverages
Bes t
1 T H E
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
Chris Powell, CEO
Two of its unique analytics offerings are Patient Population Metrics Report, a quarterly report for providers presenting insights into ordering patterns and emerging drug trends. Another offering is Geospatial Mapping, which is designed to give visibility to community partners on county-level drug use demonstrating marked variability in buprenorphine adherence as well as in fentanyl and heroin use. Aspenti IQ: A Trailblazing e-Learning Facility Aspenti Health’s innovative eLearning offering, Aspenti IQ, leverages the superlative digital learning functionality with its unique subject matter expertise. It delivers CME/CNE accredited courses in clinical best practice, protocol, compliance, patient communication, and many more mission-critical subject areas. Of all the tools available to drive better care
and prevent addiction before it starts, education is the company’s most powerful factor that transcends the entire spectrum of care touching not only patients and providers, but also families and friends. All Aspenti IQ courses are mobile-friendly and CME/CNE accredited. Each represents modern learning theory by utilizing micro-learning, scenarios-based concepts and video. Aspenti was chosen as a national partner by HealthStream, the largest Healthcare learning management platform in the country, reaching more than 4,000 healthcare organizations and hosting 4.8 million users. Aspenti will be deploying education to the front lines of care, reinforcing the quality and impact of Aspenti’s eLearning solutions with content such as “Responsible Opioid Care and Pain Management Certification”. It is a 16 course micro-certification track featuring the subject matter such as foundations, compliance, opioid misuse, and pain management. Outstanding Client Experience Aspenti strives hard to maintain loyalty
‘‘
Our vision is to create a world where we enrich every life through diagnostic science and compassionate care. Together we can end the human suffering and costs associated with substance use disorder
‘‘
strategic partnerships to gain insights into social determinants of health and align those with emerging drug trends in a meaningful way to deliver the most impactful data.
/ August 2019 /
21
Jill Warrington, CMO and satisfy its customers at every level. While talking about the same, the company shares one of its memorable client experiences. “The strength of the partnership between Aspenti Health and the University of Vermont Health Network (UVMHN) lies in the alignment of our goals to improve people’s lives. Aspenti Health’s approach is broader than just performing drug testing, by asking what it really takes on a population level to reduce the impact of substance use disorder on people’s lives. The UVMHN Department of Pathology and Laboratory Medicine is working closely with Aspenti Health, sharing the expertise each of brings to solve this national crisis in new ways; using the UVMHN as a place to pilot innovative solutions with new testing methods, education for providers, patients and families, and data analytics to clarify barriers to individuals’ success. This is a novel addition to Vermont’s already successful hub and spoke model of care for substance use disorder.”- Debra Leonard, MD, PHD Chair, Pathology and Laboratory Medicine at University of Vermont Medical Center Abiding Core Values Integrity is one of four core values of
22
/ August 2019 /
Aspenti along with innovation, inspiration, and inclusion. The company believes that it is the foundation of the quality and compliance programs that shapes the company. The role of integrity in the company’s operations enters into every aspect of the business model right from conducting its specimen collections and process testing for its patients and providers, to ensuring sound financial processes and compliance standards and interacting within organization and clients. Apart from its core values, Aspenti considers the safety of its colleagues as a critical factor. Along with meeting the standards of key regulatory bodies including the New York State Department of Health, CLIA, and the College of American Pathologists (CAP), the company also invites state and local regulatory organizations to voluntarily inspect its lab. Also, in direct patient interactions, the company has well-trained its colleagues on aggression de-escalation and traumainformed care to support a safe, nonconfrontational environment. Advanced and Secured Lab Equipment Aspenti has a state-of-the lab art laboratory designed with a LEAN,
linear workflow and reliant upon sophisticated Liquid ChromatographyTandem Mass Spectrometry (LCMS/MS) technology. This technology has been cited as a future of laboratory chemistries and requires highly specialized technical expertise to perform. The team of Aspenti has learned from related-disciplines of environmental toxicology, sports medicine, and forensic toxicology to build this focused clinical laboratory.
Diamond Medical Laboratory Providing Unmatched Mobile Healthcare Services
Andrew Diamond CEO
24
/ August 2019 /
Bes t
1 T H E
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
“Our goal is to ensure customers and patients are serviced in a compassionate and ethical manner to continuously expand our presence in nursing homes, assisted livings, and the homes of seniors
”
A
market leader spearheading with its unique approach and methodology in the medical space is Diamond Medical Laboratory. The lab delivers high quality, appropriate, and cost-effective care through its diverse, energetic, and highly trained professional staff. The prime goal of the laboratory is to ensure that customers and patients are serviced in a compassionate and ethical manner in an effort to continuously expand its presence in nursing homes, assisted livings and the homes of seniors. DML works closely with various providers that serve the same population with the goal of keeping their patients healthier and most importantly, keeping them out of the hospital. Why DML? The DML is an expert in providing quality living, nursing homes, and individual homes for seniors to provide services at their location. It provides a phlebotomist and serves the patients in their “Homes”. The lab currently processes over 90% of the specimens in its lab in Owings Mills, MD. Besides, DML is a partner with other local laboratories to run testing to benefit the patients.
DML’s owners and office staff are always available to assist its clients. It offers customized services that meet the clients’ unique needs. The laboratory is committed to personal service where one can have the comfort of speaking to a familiar voice every time they call. The team at DML gives equal importance to the commitment for the serving community. DML and its owners donate to many local charities and organizations as a way to give back to the community. Safety and Customer Satisfaction at its Highest Priority On the safety front, SOP’s have been approved by DML’s Medical Director and Lab Manager assuring that the lab complies with all state and medical regulations. The lab also provides OSHA training and regular safety trainings to make sure its staff is always using proper measures to stay safe in the lab. The management staff of DML coordinates through a collaboration portal to resolve client issues permanently and in a timely manner. They also send quarterly reports to the company’s clients containing the information about the test performed, the number of patients they have seen, along with the number of critical results they
/ August 2019 /
25
imaging company and increased the revenue by over 400% in just the span of 2 years. Andrew was approached by a representative from a skilled nursing facility about opening a medical laboratory to serve their residents in October 2016. That is when the decision to open Diamond Medical Laboratories was made. Mike Kluttz, the CEO of DML is a graduate of UMBC with an undergraduate degree in business management and biology. He has over 35 years of experience with various laboratories and for last 24 years he has been in a management position. Mike has been the acting CEO of the clinical laboratory for approximately 4 years.
have come across. The team also attends their quarterly meetings to exchange information and resolve problems related to client satisfaction. “We take client satisfactions very seriously. I provide my cell phone number to all clients as a way to expedite a resolution. We review all client concerns monthly and ensure that the time frame we respond in is as timely as possible,” says Andrew. The Vibrant Trio at the Laboratory The Founder of Diamond Medical Laboratory is Andrew Diamond. He received an undergraduate degree in Criminology from the University of Maryland College Park. After graduation, Andrew managed a branch of a Nationwide Mortgage Company for 5 years. He eventually sold the business to his partners and created Marvel Title and Escrow. In 2014, he purchased ownership in Mobile Medical Imaging, a portable
26
/ August 2019 /
Another important persona at DML is David Robinson, the Chief Laboratory Officer of the lab. He is an army veteran having 27 years of enriching experience in clinical and research laboratories. He has handled diverse positions in the field, right from Phlebotomist to Laboratory Supervisor and even as a Clinical Research Coordinator. He has also worked in small laboratories, field hospitals, and even large medical centre laboratories. For the past 4 years, he has worked as the Laboratory Service Manager at DML. Future Goals Diamond Medical Laboratory wishes to serve 100 skilled nursing facilities along with 30 assisted livings and 100 home bound patients a day. The laboratory will be putting together an antibiotic or anti-microbial stewardship program to assist its Skilled Nursing Facilities in compliance with Federal mandates. Besides, it is also looking forward to initiating more molecular testing to provide its clients with faster results, which would avoid re-administer to the hospital.
DNAfit Personalizing Wellness with Cutting-edge DNA Tests
A
n award-winning and renowned market leader that has a big vision for UK healthcare is DNAfit, part of the Prenetics Group. The company is eager to put power in people’s hands to take charge of their health using their bodies as the best source of intelligence. DNAfit is helping people reach their wellness goals faster, as well as playing its role in reducing pressure on the NHS. In 2018, DNAfit were acquired by Prenetics, giving it a depth into the range of available genetic tests. Prenetics is a leading genetic testing and digital health company headquartered in Hong Kong and London and has offices in 10 countries globally. Prenetics owns laboratories, conduct and publish their scientific research. It has over US $50m in strategic investments from Alibaba and Ping An, making them one of the fastest-growing genetic testing and digital health groups globally. Later this year, DNAfit has plans to get behind various preventive diseases that can help people make preventative lifestyle changes. Why DNAfit? DNAfit has a mission to use genetics to transform the health and wellness outlook for millions of people. The
28
/ August 2019 /
Avi Lasarow Founder & CEO
Bes t
1 T H E
MEDICAL & CLINICAL
LABORATORIES
‘‘
‘‘
TO WATCH FOR 2019
We're Eager To Put More Power In People’s Hands To Take Charge Of Their Health, Using The Best Possible Source Of Intelligence- Their Bodies
company strives to reduce and prevent lifestyle-related health conditions, making everyone live longer, healthier, and happier lives. It has a vision to not only make people aware of what their bodies need to be healthy, but also to motivate them to be proactive in making positive changes to benefit their health. DNAfit has published the world’s first genetically guided exercise intervention study, alongside many other studies looking at gene x environment interaction. Its products provide a lab report along with the personal one to one health coaching, online exercise, and meal planning platforms and at-home blood testing.
After selling his previous company, Lasarow started to focus on getting fit and healthy. At that point, he began looking at the role that genetics plays in how we respond to different kinds of exercise and nutrition. Lasarow noticed that, although genetics was becoming increasingly popular for ancestry, nobody was concerned with using their genetic profile to inform their health and wellbeing choices. He saw this as an opportunity to help people put their genetic data into action and began applying this personalized approach to his own nutrition and workouts. Achieving great results and seeing the amazing impact genetic insight can have led Lasarow to create DNAfit as a way to help others reach their health goals.
The Influential Leader Avi Lasarow, the Founder and CEO of DNAfit has dedicated over a quarter of his life in the relentless pursuit of science and technological innovation. He is driven to pioneer and humanize science that was unreachable, unexplainable and unaffordable for so long, His sheer commitment to making DNA results more accessible has meant that thousands of people across the world can live happier & healthier. The Inception Story Having worked in the life sciences industry for several years, Lasarow was much aware of the life-changing potential of health technology, but it was his personal experience that made him realize the important role of personalization in getting people to make healthier choices.
Assuring Safety and Quality with Cutting-edge Technology DNAfit uses advanced technologies in all of its laboratories and uses small targeted PCR analysis, custom Illumina SNP array analysis and Whole Exome Sequencing for all parts of its services. The company applies gold-standard Agile project management methodologies across its whole business and client communications following Prince2 & PMP protocols. Also, each client of DNAfit is assigned a ‘partner implementation manager’, who liaises directly with the client. The partner implementation manager looks after their needs and timelines are communicated accordingly. This provides a single, consolidated voice to the client, along with providing the power of the wider team to move quickly and deliver a quality service.
/ August 2019 /
29
Salient Client Experience DNAfit has been working immaculately to provide its clients with innovative services and its happy customers bring the same reflection with their valuable feedbacks. One of its clients shares the experience and delivers“If you genuinely care about your health and well-being, this is for you! I signed up for this through my company’s perks and I am so glad! The results of the DNA test was very much on par with my personal medical history and experience. I have found the resources available to you invaluable and I use the fitness portal and also created some meal plans. The consultation with the sports scientist was spot on, comprehensive and yet broken down to basics to help you understand your report. The whole experience has created a real buzz in the office and boosted overall morale on my pod.” - Sheila Bynoe Cert CII (Health and Protection), Client Relationship Manager at Chase de Vere Independent Financial Advisers Limited (a Swiss Life company) Awards and Accolades In 2015, DNAfit was awarded the ‘Lloyds Bank National Business Award for Innovation’ and was named in ‘The Fast Company’s Top 10 Most Innovative Businesses in the Data Science sectors’ which had alongside names such as Netflix, Spotify and NASA. DNAfit were also presented with the Board of Trade Award in audience of a UK Prime Minister. Most recently, DNAfit is honoured to have been awarded ‘The Queen’s Award’ in two categories namely the highest official UK Awards for British businesses, and another for the Innovation and International Trade.
30
/ August 2019 /
Committed to Better Living through Chemistry
S
an Diego Reference Laboratory (SDRL) is a fullservice, client-focused analytical biomedical testing laboratory first licensed in January of 1989 as a commercial clinical laboratory. The founding purpose of the laboratory was to provide clinical and toxicological laboratory services to the law enforcement community, private industry for pre-employment testing, and drug treatment clinics. SDRL has been a leader in the toxicology and clinical laboratory testing field for over twenty-five years and has been a pioneer in methadone drug testing since 1993. The laboratory’s core mission is to provide the highest quality of testing, superior customer service, and competitive pricing to a broad range of clients throughout the United States. It is dedicated to meeting the needs of its customers by delivering comprehensive clinical and drug testing toxicology services with a commitment to accuracy, expediency, and accessibility. Distinctiveness of the Lab At SDRL, the team takes pride in the
32
/ August 2019 /
technical expertise and assistance they can offer clients. The team communicates daily with their clients, learns about new trends in the addiction community, and continually expands the testing menu accordingly. They support these expanded tests with Technical Briefs, which are informative bulletins sent to the clients that explain the test and its interpretation. In 2011, SDRL initiated writing The Toxicology Times (toxtimes.com), a monthly publication for clinicians and counsellors. This monthly publication reviews various topics surrounding the interpretation of clinical results, drugs, metabolism, elimination and impact on the patients’ health. With this depth of technical expertise, the lab is recently certified to provide Continuing Education Units (CEU’s) to its client’s technical staff. SDRL’s client service phone lines are always answered by a live customer executive. The lab’s senior management, including the CEO, is also available for more in depth and technical explanations.
In order to maintain certain licenses and certifications, SDRL participates in several proficiency programs including California Methadone Drug Analysis Laboratory Proficiency program, Pennsylvania Proficiency Testing, as well as the College of American Pathologists Forensic Drug Testing (CAP FDT). How was SDRL Established? The lab was started in 1989 in response to the change in the testing marketplace. There was a developing need in the opiate treatment clinics for reliable and cost-effective toxicology testing that was performed quickly and accurately. The California laboratory license requirements to provide services to these treatment organizations are very rigorous and quite exacting. The license is built around definitive drug testing procedures and blind proficiency testing. With “blind” proficiency testing, the proficiency samples are sent to the clients of the testing laboratory. They are then repackaged and relabelled with pseudo patient names and submitted to the laboratory. The
Bes t
1 T H E
MEDICAL & CLINICAL
LABORATORIES
laboratory performs the tests and reports the results to the clinic. These results are then sent to the regulatory agency by the client. Proficiency testing is done on a monthly basis with a variable number of samples and the laboratory must maintain a score of 90% or greater to maintain licensure.
TO WATCH FOR 2019
There was also a need to offer clinical and wellness testing to the patients in the programs, which was not being offered at that time. Today, SDRL supports the physicians with functional testing in serology, hematology, and immunology as well as liver function tests. This testing supports the clinical maladies that result from drug addiction. Avant-garde Lab Equipment SDRL utilizes the latest cutting-edge laboratory technology where all specimens are barcoded with a unique number and are tracked throughout the laboratory testing process with an exact chain-of-custody. The initial analysis of the specimen is performed by high-speed analytical instruments for reliable and quick identification of various levels of substances by drug class. At the lab, the specimens are stored in a secure facility to make them available for further testing. All reporting is done same day; results are available on the clinic’s web portal in a secure fashion and are available for review anytime. Furthermore, confirmations can be performed on abnormal results to identify the specific analyte of the drug class by state of the art HPLC/MS/MS or GC/MS methodology. With its up-to-date quality control, SDRL makes QC results available to its clients as further assurance of their work.
Dr. Joseph Graas Lab Director
/ August 2019 /
33
‘
We Are Dedicated To Meeting The Needs Of Our Customers By Delivering Comprehensive Clinical And Drug Testing Toxicology Services
With regards to safety, SDRL is a drug-free workplace and has a strict drug testing policy and enforcement of such requirements. All employees are trained, and follow, Standard Operating Procedures (SOP’s) as required by each department. The lab maintains proper training checklists for all employees to ensure proper procedures are being followed. In conjunction with training, they have safety meetings with all employees, maintain a safety monitor in each section, and provide appropriate Personal Protective Equipment (PPE).
About the Leading Light Dr. Joseph Graas, the founding member of SDRL, is the Laboratory Director. Dr. Graas holds a PhD in clinical chemistry and toxicology and has an extensive background in the field. Having participated in laboratory operations for nearly fifty years, he is considered as an expert in the field of toxicology and has been retained to testify in court in many state and federal cases. He is a member of the American Chemical Society, American Association for Clinical Chemistry, California Association of Toxicologists, and a Fellow of the American Institute of Chemists and National Academy of Clinical Biochemistry. Dr. Graas has many technical publications and patents in the field of Chemistry.
Bringing in Quality The team of SDRL works with clients to solve any issues they might experience and help explain results both verbally and with supported documentation, such as the Toxicology Times. They attend and present at various conferences to learn new information in the field, have added new testing techniques, and have expanded their test menu to assist their clients keep up with new trends in drug abuse. SDRL has taken special projects for clients to help them further understand what’s going on with their patients,
34
/ August 2019 /
specifically pregnant females taking methadone, medication interactions, and dosage compliance. Happy Clients of SDRL SDRL shares some of the memorable feedbacks from its clients. • “We are so pleased with our decision to change labs. Every aspect of SDRL’s service is superior to what we were receiving. SDRL continues to surpass our expectations. Real people answer the phone, and everyone is helpful and knowledgeable.”- J. F. – Owner/Executive Director, California” • “The level of service I receive from SDRL is unmatched – they make me feel like I’m the only customer they have. I would highly recommend SDRL to anyone searching for a supportive, trustworthy and responsive laboratory!”- D.M. – Owner, Illinois Other Services SDRL has implemented a 2D barcode system that allows for efficient and error free receipt of the patient samples and tracking throughout the testing and storage process. Its clinical testing is geared towards the treatment of the patients. The lab also streamlines the process from the clinic to the laboratory and customizes services for each client. So, it’s not a ‘one size fits all’. Future Goals SDRL wishes to expand the clinical laboratory testing and to launch Therapeutic Drug Monitoring for all medications offered by client physicians in the treatment of their patients. The laboratory is also planning to monitor the spread of fentanyl and fentanyl analogues in its patient population and to expand its clinical testing menu to include health and wellness testing. Additionally, SDRL will continue to focus on maintaining and improving customer care and enhancing quality management.