While large commercial laboratories and academic medical center laboratories have been conducting testing for clinical trials for years, mid-size regional laboratories are more recently getting into the clinical trials business, partly as a way of diversifying their revenue streams.
Large labs lead the way
ARUP Laboratories (Salt Lake City) has performed laboratory testing for clinical trials for more than 15 years through its Clinical Trials and PharmaDx groups, according to medical director Jay Patel, MD. “Clinical trials testing represents a small but growing component of ARUP’s clinical operations,” he says. “In a typical year, ARUP supports laboratory testing for over 1,200 clinical trials. These trials span a wide range of disciplines and reflect ARUP’s broad clinical expertise.”
A few years ago, ARUP Pharma Services partnered with an international pharmaceutical company to create two FDA-approved diagnostic tests that help patients with mastocytosis and myelodysplastic syndromes find out which medications work best for them. Breakthrough therapies based on the targeting of the D816V KIT mutation are now being used to treat mast cell disorder, a diverse group of conditions characterized by inappropriate mast cell activation.1
LabCorp (Burlington, VT) entered into the clinical trial business in 2014 with its acquisition of Covance, a drug development company. At the time, LabCorp said the acquisition of Covance would create new sources of revenue for the laboratory and broaden the company’s customer base. In 2019, Covance’s revenues of $4.58 billion represented almost 40 percent of LabCorp’s total revenues of $11.55 billion.1
Quest Diagnostics (Secaucus, NJ) followed shortly after with the 2015 launch of Q2 Solutions, a global clinical trials laboratory services organization, formed as a joint venture with IQVIA (formerly Quintiles). Q2 Solutions supports studies in multiple therapeutic areas, the largest of which is oncology and hematology, which makes up 44 percent of its clinical trial business. Q2 Solutions revenues are not public.
BioReference Laboratories, which was purchased by OPKO Health in 2015, has performed testing for myriad clinical trials, including one to determine the efficacy of certain cancer therapeutics that target a patient’s genetic alterations, regardless of cancer type. BioReference’s GenPath Oncology Diagnostics division used its OnkoSight next-generation sequencing assay to test patients enrolled in a National Cancer Institute Phase II clinical trial, Molecular Analysis for Therapy Choice (MATCH).1 Through the collaboration, which began in 2018, GenPath notified treating oncologists at one of the 1,100 sites that participated when a genomic alteration was detected by OnkoSight that was a match to an NCI-MATCH treatment arm. That study ultimately showed that treatment with dabrafenib (DAB) and trametinib (TRM), a drug combination developed to treat cancers that have a specific BRAF-gene-mutation, was effective in treating a group of patients representing 17 distinct tumor types.1
Regional labs get in the game
But the big commercial laboratories are not the only ones finding the clinical trials business beneficial. Wisconsin Diagnostic Laboratories (WDL; Milwaukee, WI), in partnership with the Medical College of Wisconsin and other commercial partners, participates in 40 to 50 active trials each year, about 10 percent of which yield clinically relevant results, says president Steve Serota. WDL is a regional laboratory serving more than 30 hospitals, 700 long-term care facilities, and 250 outreach practices in Wisconsin and the Chicago area.
The trials for which WDL provides testing range from routine testing to specialized protocols in anatomic pathology, clinical chemistry, and cytogenetics. WDL charges investigators a standard rate for the testing; investigators in turn typically receive grant funding to cover costs of the trials.
The clinical trials business represents less than six percent of WDL’s total revenue, but Serota says the benefits go beyond dollars. “Diversification of revenue is one of the reasons we continue to do it, but the business also aligns with our mission,” he says. “There are direct benefits to our community. If new treatments become available as a result of a trial, we build into our contract that we get early access. Employees also get access to cutting-edge technology.”
WDL develops, implements, and maintains highly reliable, specific protocols for clinical studies, which eliminates deviation and improves the validity of the study, says Serota, noting that there is an entire team focused on working with primary investigators to identify appropriate testing methodologies and to ensure quality and documentation necessary to fortify the research study.
Serota explains that many of the opportunities for research testing come from existing relationships. For example, WDL provides reference laboratory services to a health system for cytogenetics and was asked to provide testing for cytogenetics research.
Research testing may not be feasible for all laboratories as it requires a substantial amount of administrative work, notes Serota. “Most of these clinical trials require very specific protocols,” he says. “The development and implementation of those protocols outside our normal laboratory operations does present some challenges, but we’ve become very good at creating these policies and procedures.
Marshfield Laboratories, a regional lab in Marshfield, WI, serving Wisconsin, Eastern Michigan, and Eastern Minnesota, performs research testing for a number of clinical trials being conducted by Marshfield Clinic Research Institute. The institute, founded in 1959, is one of the largest research facilities embedded within a regional, integrated health care system. In 2018, the institute conducted more than 800 research projects, including 180 clinical trials.1 The focus of the research ranged from how early infections can predict the age distribution of seasonal influenza A cases to the effect of Setmelanotide on obesity in Bardet-Biedl Syndrome.
In July 2020, Marshfield’s Integrated Research and Development Laboratory received a $22.5 million grant to partner with the Centers for Disease Control and Prevention (CDC) as the sole central reference lab in the nation for COVID-19 studies. The lab will assist the CDC in designing and implementing several studies, as well as collecting data from labs across the nation. This is not the first time the lab has partnered with CDC. They previously worked together in 2009 during the H1N1 pandemic.1
Jennifer Meece, director of the laboratory, said it would double the number of scientists as it prepares to conduct COVID-19 tests on samples received from study subjects across the US. These studies will help define what we know about the new virus and help shape the scientific response to it.
“It’s going to teach us a lot about the transmission dynamics, who’s at risk, who are the ‘super shedders’ [of the virus] or asymptomatic shedders, as opposed to people who get the virus and get really sick,” she said in an interview with Wisconsin Public Radio.1
With almost 350,000 research studies currently underway in the world1 , the need for accurate, comprehensive, and well-documented testing by clinical laboratories is clear and potentially provides a source of revenue-diversification and access to cutting-edge technology for mid-sized laboratories.