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LabCorp's Covance Sees Place for Itself in New Drug-Dx Codevelopment Landscape

NEW YORK (GenomeWeb) – In May, news broke that the US Food and Drug Administration had approved Merck's Keytruda as the first drug ever okayed on the basis of genomic features in cancer patients' tumors, instead of where the tumor occurs in their bodies. While the new drug indication didn't come with an FDA-approved companion test, it did highlight the need for such a diagnostic, and prompting companies like Promega to plan to seek FDA clearance for an assay based on microsatellite instability technology for the detection of colorectal cancer.

As personalized medicines based on genomic features become more prevalent in the clinic, the need for companion diagnostics to test for those features will increase. As such, Laboratory Corporation of America's Covance Drug Development subsidiary recently announced that it would open a dedicated companion diagnostics laboratory in Morrisville, North Carolina. The new lab is part of a multi-use facility that also includes a genomics and molecular pathology laboratory to support clinical trials and diagnostic assay development, and a nuclear magnetic resonance lab, the company said.

"Covance has many laboratories that support drug development, from preclinical to central lab services, and those are spread out globally. But this is the first lab that is dedicated to the development of assays that help fulfill the promise of precision medicine and companion diagnostics," Covance CSO Steven Anderson said in an interview.

"The other aspect is that Covance and LabCorp have a long history in this space and we've been involved in developing about 75 percent of the companion diagnostics that are in the marketplace today," Anderson added. "So, I think the better understanding of biology that leads to precision medicine supports a more targeted approach to drug development, and with that targeted approach comes a need for assays like companion diagnostics that guide those approaches."

Covance also noted that it participated in more than 60 companion diagnostic programs supporting 145 clinical protocols in 2016.

The mission for this new facility, Anderson said, will be to develop assays that are based on genomics molecular pathology, and to support clinical trials that are done globally in the pursuit of new therapeutics. "We have the capability to develop assays and to support them all the way through trials," he noted. "Also, where appropriate, [we can support] the regulatory submission of those assays and even the commercialization of those assays, once they're approved as companion diagnostics in the LabCorp diagnostic laboratories."

Further, through this lab, Covance will be able to continue its work running assays that have been developed through partnerships between pharmaceutical and biotechnology companies and in vitro diagnostics developers. However, the firm is also hoping to provide its customers with specialized assay development and scientific expertise through this lab. And though he declined to give specific details, Anderson said the lab has some projects with other companies in the development phase.

Because the lab is dedicated to companion diagnostics, he said, the staff can focus its considerable expertise on using the various tools it has available for one purpose, and to not only evolve with the technology, but to be able to do some innovating its own. "We have a toolbox now at this location, [and] staff that are skilled at using that toolbox," according to Anderson. "In that toolbox are things like next-generation sequencing, and as the need for diagnostics evolves and companion diagnostics evolve from looking at a single gene to multiple genes, we'll be poised and ready to do that."

The new lab, Anderson emphasized, "sits in the middle of the drug development business and the diagnostic business."

Canaccord Genuity analyst Mark Massaro believes the new lab is a "logical extension" of Covance's existing diagnostics business. "It's likely that they are adding capacity to meet their outlook for growing demand," he said in an email. "New state-of-the-art labs typically have new bells and whistles, instrumentation, and this may enable LabCorp to win some competitive deals as prospective customers visit their lab and then choose to work with them."