Hematogenix Laboratory Services, a company that provides integrated pathology services for drug development, has been included by Merck & Co. as a national reference laboratory for the U.S. Food and Drug Administration-approved PD-L1 companion diagnostic assay PD-L1 IHC 22C3 pharmDx for Keytruda.
Hematogenix announced in 2016 that it would offer the test through Dako's PD-L1 IHC 22C3 pharmDx kit. In October, the FDA approved Keytruda, the first FDA-approved checkpoint inhibitor for treating lung cancer.
"By providing broad access to high quality PD-L1 testing, we will continue to help our oncology doctors identify the most appropriate treatment options for their patients,” Hematogenix CEO Hytham Al-Masri said in a statement. “We support our pharma clients globally by offering these assays in both our US and European locations."
The company's Alderley Park, U.K. facility was awarded College of American Pathologists (CAP) accreditation in December 2016. Hematogenix is a CAP/CLIA-certified laboratory that offers various biomarker development and testing services that help deal with human subject clinical trial complexity.