By Deepa Narwani, Informa Life Sciences, Dubai, UAE , 19 December 2016

Medlab Magazine spoke to Dave King, CEO, LabCorp about their partnership with National Reference Laboratory in Abu Dhabi and the latest advancements in the lab

In 2008, LabCorp entered into a long-term strategic partnership with Mubadala to create and manage National Reference Laboratory (NRL). Laboratory Corporation of America Holdings, a S&P 500 company with roots going back more than 100 years, is headquartered in Burlington, North Carolina.

The partnership between LabCorp, Mubadala and NRL is unique in the region, says Dave King, CEO, LabCorp.

He highlights, “Our objective was to create a diagnostic laboratory in the UAE to serve the region with the same standards as the world’s leading clinical laboratory. To accomplish that, LabCorp actively participated in laying the foundation of NRL’s systems and procedures by openly sharing our expertise, including sending LabCorp employees to NRL for extended periods of time and sending LabCorp experts on regular visits to NRL. Those initiatives have allowed LabCorp’s significant operational and scientific expertise to be brought to UAE patients, delivering sustainable and long-term benefits to the UAE health system and the patients it serves. Additionally, LabCorp’s support has allowed NRL to quickly become a UAE and regional leader and to establish a strong reputation as a quality-driven and patient-centered laboratory.”

LabCorp continues to support NRL in various ways, such as:

• Helping to establish NRL’s Centers of Excellence, in order to bring more specialized tests in-country. NRL is working to establish Centers of Excellence for molecular genetics, anatomic pathology, special coagulation, flow cytometry, protein studies and tuberculosis testing.
• Supporting the continuous medical education of the region’s laboratory professionals. NRL in cooperation with LabCorp is organising a workshop on special coagulation during the MedLab conference in February 2017. Mike Tyler, LabCorp’s Esoterix Coagulation Lab Manager, will lead the workshop.
• Supporting NRL’s laboratory automation projects.
• Providing highly sophisticated reference testing to the region.
• On-going consultative support for managing hospital-laboratory networks.

He adds, “Quality healthcare is so fundamental to a person’s quality of life, so the UAE is a rewarding place to have established a partnership that is making people’s lives better in tangible ways. We’re thrilled to see that this collaboration has allowed NRL to quickly become a UAE and regional leader and to establish a strong reputation as a quality-driven and patient-centered laboratory.Most importantly, we are glad to see that through this partnership, LabCorp and NRL are able to deliver sustainable and long-term benefits to the UAE health system.”

LabCorp’s mission, says King, is to improve health and improve lives by delivering world-class diagnostic solutions, bringing innovative medicines to patients faster and developing technology-enabled solutions to change the way care is provided.

Focus on Accreditation

LabCorp participates in numerous externally administered quality-surveillance programmes, including the College of American Pathology (CAP) program, an independent non-governmental organisation of board-certified pathologists that offers an accreditation program to which laboratories voluntarily subscribe. LabCorp supports CAP accreditation because it provides guidelines that offer greater quality, compliance and consistency, all of which are critical to clinical laboratory testing.

King highlights, “The CAP programme involves both on-site inspections of the laboratory and participation in CAP's proficiency-testing programme for all categories in which the laboratory is accredited. All of LabCorp's major diagnostic laboratories and Covance Drug Development Phase I clinical-research units in Evansville, Indiana, and Dallas, Texas, are accredited by CAP.”

Spotlight on Automation

King stresses that LabCorp is continually focused on improving patient outcomes by focusing on quality and productivity while lowering costs throughout all phases of its operations supported by LabCorp Diagnostics’ technology, automation and facility rationalization initiatives.

He says, “One example of automation that has been implemented in several of LabCorp’s primary labs is Propel, a proprietary technology developed by LabCorp that improves efficiency and quality throughout our entire supply-chain process. The front-end automation revolutionises how we process serums, resulting in improved specimen quality, process streamlining and improved customer service.

“Additionally, we recently became the first U.S. laboratory to deploy Roche’s new Cobas 8800 molecular testing system, which completely automates the entire testing process for certain tests. The system is in use at our Center for Esoteric Testing lab in Burlington, North Carolina, and is initially being used for Hepatitis C testing. Over time, we plan to also move testing for Hepatitis B and HIV onto the system, and we hope to introduce the system into additional laboratories. The system improves test quality, consistency and efficiency, and allows for lab space and staff to focus on other testing.”

LabCorp continually extends its expertise and experience in laboratory automation to NRL’s project for full automation of its laboratories, which is currently underway at NRL.

Role of Big Data and Personalised Medicine

LabCorp’s global presence and end-to-end approach give the company a major advantage in terms of the ability to utilize Big Data, says King. LabCorp performs roughly 100 million tests per year, and Covance Drug Development generates more safety and efficacy data to support drug approvals than any other company. That data can be leveraged to bring innovative medicines to patients faster. Through LabCorp’s proprietary patient portal, the company is able to leverage diagnostic data to identify and potentially speed patient recruiting for drug trials – one of the biggest challenges drug companies face in bringing new drugs to market.

“Personalized medicine is not just the wave of the future. In many ways, it is already here,” says King. “And as a leader in genomics and companion diagnostics, LabCorp is poised to be on the front end of this evolution in changing the way care is provided. Our acquisition of Covance was driven in part by our recognition that the future of healthcare will require closer integration between diagnostics, drugs and devices, and a shift – which is already underway - from treating the general symptoms of disease to understanding the specific patient and how diagnostics can determine the right treatment for that particular patient.”

In terms of how personalized medicine will affect the lab industry, doctors, patients and their families have found great value in laboratory tests that help predict, diagnose and treat disease. By examining the molecules in an individual patient’s organs, tissues and bodily fluids, the science of molecular pathology helps predict whether and how a disease might spread, and how a specific person might respond to a specific treatment. This is the essence of what personalised medicine is all about, and it can create better outcomes for patients and drive down healthcare costs by identifying treatments with the greatest likelihood of success for a specific patient. Through NRL, these highly specialized tests are available in the UAE and the region.

Evolution of Point-of-Care Testing

While point-of-care testing has been around for decades, it seems to be accelerating as a trend to watch. Over the years, it has proven its value in niche applications, especially in hospital settings where having test results within minutes can have a meaningful impact on clinical decision making.

King says “LabCorp has experience deploying point-of-care testing in the field for some of its customers, and we continue to position ourselves to lead in this area as it develops. However, the industry has seen that cost and quality considerations have slowed wide-scale adoption to date. Tests suitable for point-of-care -- either due to the technology constraints or those that would be reasonably necessary at point-of-care -- may be relatively limited for the foreseeable future. In the long term, technology advances may overcome these barriers, at which time having robust point-of-care capabilities may become a requirement of operating as a modern laboratory. In the meantime, we continue to see a significant role in healthcare for high-quality, standardized testing done in high-through-put, technology-enabled labs with thorough analysis done by an experienced, trained professional, all of which LabCorp offers today.”

Future Trends

In the U.S., like many other countries, says King, the conversation about healthcare will increasingly revolve around cost. Budget reductions and new payment models are beginning to force structural change. Hospitals are consolidating and purchasing physician practices. Payors are consolidating in response. Labs and all other sectors of healthcare will increasingly face reimbursement pressures and utilization-management scrutiny. There is increasingly new and changing government regulation, as well.

He adds, “However, in each case, we believe that LabCorp is well positioned to respond positively and thrive despite, and in some cases because of, those challenges,” says King. “It will be important to continue to leverage technology to improve efficiency. Also, given that lab testing influences 70% of medical decisions but only accounts for 2-3% of costs, there are opportunities to create new clinical-decision-support capabilities to help physicians more efficiently manage disease states.

“In the UAE region, it is at times challenging to source qualified, experienced medical technologists and other laboratory personnel. In addition, there is a limited availability of esoteric and genetic testing locally, and, therefore, there is still a significant dependence on send outs. LabCorp is helping NRL to bridge that gap by establishng a number of centers of excellence that will provide comprehensive testing in several areas.”

Today, patients play an increasingly larger role in the healthcare decision-making process as they bear greater financial burden, according to King. 

He says, “We are working on several new tools and offerings to enable more convenient consumer-initiated interactions and engagement when it comes to lab testing. In the long term, we see technology enabling more convenient specimen collection for some types of testing. For example, with the rise of consumer-genetics companies such as 23andMe and Ancestry, a large portion of genetic testing performed in the United States is now performed using saliva as a specimen. This is not clinical testing, but it is only a matter of time before things move there.

“On the topic of genetics more broadly, we anticipate long-term change as the cost of sequencing continues to decline. The lines between consumer-, research-, and clinical-testing applications will become very blurry, and in the future, we believe it will become common for everyone to have their whole genome or whole exome sequenced. This, however, will take time.”

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Significant Developments

The last few years have been important ones for LabCorp in establishing the company as the world’s leading healthcare diagnostics company, providing comprehensive clinical-laboratory and end-to-end drug-development services. Below are a few highlights.

Covance - In February 2015, LabCorp completed its acquisition of Covance Inc., a global leader in drug-development services, which significantly expanded the company’s offering to the biopharmaceutical industry, increased the company’s international presence and enhanced the company’s financial-growth opportunities.
Sequenom - This year LabCorp acquired Sequenom, Inc., a pioneer in non-invasive prenatal testing (NIPT) for reproductive health. LabCorp already provided the most comprehensive genetic-testing menu in the industry, and Sequenom’s market-leading NIPT and genetic-testing capabilities advance LabCorp’s strategy to deliver world-class diagnostic solutions.

New Tests – LabCorp currently offers more than 4,700 clinical, anatomic-pathology, genetic and genomic tests. Over the past year, LabCorp introduced more than 75 new assays and continues to introduce new and novel tests, including the following:

• In May, they announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved for clinical use.
• In June, LabCorp announced the availability of a new application for the companion diagnostic associated with the use of Tarceva® for the treatment of certain patients with non-small cell lung cancer (NSCLC). The Roche cobas® EGFR Mutation Test v2 is the first blood-based test approved for clinical use in the U.S. to detect certain epidermal growth factor receptor (EGFR) gene mutations in NSCLC patients.
• In August, they announced the nationwide availability of testing for Zika virus using the Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) developed by the Centers for Disease Control and Prevention (CDC).

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NRL at Medlab 2017

• Dr Basel Altrabulsi, Clinical and Anatomic Pathologist, Medical Director, NRL will be speaking on ‘Managing the anatomic pathology laboratory’, on Feb 6 at 1.30pm
• Dr Frank Ryan, Technical Director, NRL, will be speaking on ‘Laboratory screening and diagnosis of Gestational Diabetes Mellitus’, on Feb 8 at 11am
• Gagan Goel, IT Director, NRL, will be speaking on ‘Standardisation of Lab compendium and its management to obtain Computable Semantic Interoperability’, on Feb 9 at 11.30am

Dr Shereen Atef, Consultant Clinical Pathologist, NRL will be speaking on ‘The evolving use of serum free light chain assays in clinical laboratory’, on Feb 9 at 12.30pm.