By Turna Ray
If a factory is where raw components are manufactured and assembled into commercial products, then why not take a similar approach to developing diagnostics to predict disease predisposition and response to drugs?
Duke University and the Laboratory Corporation of America have put their collective expertise together to create just such an enterprise, which they've dubbed the Biomarker Factory. The project, announced earlier this month, enjoins Duke University Medical Center's expertise in biomarker discovery and LabCorp's capacity to develop laboratory-developed tests from validated biomarkers.
"The Biomarker Factory will make decisions to develop potential biomarkers on the basis of preliminary signal, feasibility, market considerations, and other factors relevant to the likely commercial value of new diagnostic technology," a Duke spokesperson told Pharmacogenomics Reporter this week. "LabCorp will evaluate the strategic and commercial value of Biomarker Factory discoveries and exercise options using its judgment and customary business processes."
According to LabCorp CEO David King, the Biomarker Factory positions Duke and LabCorp on an "end-to-end pathway from the research bench to the physician office." The partners did not say which disease area they will focus on or how many samples in total they will collect.
The two most oft-cited bottlenecks to personalized medicine are the lack of clinically validated and clinically useful biomarkers, and reimbursement. To close the latter end of the missing link, payor groups are joining forces with companies like DNADirect and Generation Health that can educate physicians and doctors and manage genetic test utilization to make more efficient use of health care dollars. LabCorp's collaboration with Duke presents a step toward filling the gap at the other end of the spectrum by developing biomarkers that can be clinically meaningful and have a greater chance of being adopted.
There are similar efforts underway elsewhere. The Foundation for the National Institutes of Health manages the Biomarkers Consortium, a public-private biomedical research partnership to develop, validate, and qualify biomarkers and speed the development of healthcare products to detect and prevent diseases.
The US Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare & Medicaid Services have also formed the Oncology Biomarker Qualification Initiative to develop personalized treatments and diagnostic testing in cancer.
Through the formation of LabCorp and Duke's Biomarker Factory, the partners expect to develop "deep knowledge about appropriate use of biomarkers in clinical practice and how to provide this information so that patients and doctors can make better decisions," Andrew Conrad, LabCorp's chief scientific officer, said in a statement.
Duke will contribute “hundreds of thousands of biological samples” to the factory. The university already has the basic infrastructure in place for a biomarker repository and sample collection capacity from conducting an epidemiology study called MURDOCK (Measurement to Understand the Reclassification of Disease of Cabarrus/Kannapolis), for which it is currently recruiting 50,000 people into a registry.
LabCorp in turn has its own biorepository in Kannapolis, NC, which Duke helped LabCorp build. The resources in LabCorp's existing repository will be part of the Biomarker Factory.
"The Biomarker Factory will leverage existing assets in both founding organizations and focus them in a new way to rigorously demonstrate the utility of biomarkers to stratify disease, conserve healthcare resources, and optimize health outcomes," Victoria Christian, chief operating officer of the Duke Translational Research Institute, said in a statement. Christian spearheaded the enterprise.
The collaboration between Duke and LabCorp grew out of the recognition that in order to translate biomarkers from the discovery phase to patients' bedsides, there needed to be a way to sift through the noise of early research and identify robust, commercializable targets.
Although Duke had experience in the collection and analysis of samples for biomarker signals through the MURDOCK study, the university “recognized the value of having a partner with expertise sorting between signals that have potential as diagnostic products from those that are interesting (and potentially hypothesis-generating) but less informative or commercially feasible,” a Duke spokesperson said in an e-mail.
The agreement between Duke and LabCorp focuses on the operation of the facility, as well as the management of samples deposited by Duke and its clients and collaborators, including samples from the MURDOCK study. “Although the biorepository itself doesn’t focus or specialize in any particular disease state or research topic, the centralized storage of high volumes of clinically significant samples provides a rich resource for research and development, including the research that will fuel the Biomarker Factory,” the Duke spokesperson said.
LabCorp’s existing biorepository stores biological samples for academic centers, research organizations, and biotech firms. As such, when it comes time to commercialize a validated biomarker, LabCorp will already have relationships with entities that could provide resources in that regard.
“There is an appropriate level of flexibility and complexity in the Biomarker Factory agreement to allow Rx/Dx collaboration both within and without the Biomarker Factory, including the possibility of multiple-party collaboration,” the Duke spokesperson said.
In the development of commercial laboratory-developed tests, however, the partners are open to exploring new and emerging technologies, and aren't married to any one technological platform. In fact, the partners may use one kind of platform in biomarker discovery and validation, but go with another platform for the marketed version of the test.
“The Biomarker Factory is agnostic as to technology platforms. We believe this will encourage a broad range of explorations that are linked to different platforms based on sample type, patient population, competitive landscape, intellectual property, etc.,” the spokesperson said.
“Platforms used to make initial discoveries may not be exactly identical to the platforms deployed as assays are optimized or introduced commercially,” the spokesperson added. “We believe this will provide maximum flexibility and will permit incorporation of appropriate translational and technical steps along the discovery and commercialization path.”