Hematogenix, an industry leader in the field of integrated pathology services for drug development and clinical testing, announces the availability of the FDA approved PD-L1 companion diagnostic assays PD-L1 IHC 22C3 pharmDx for Keytruda, Merck's Anti-PD-1 therapy for metastatic non-small cell lung cancer, and PD-L1 IHC 28-8 pharmDx, a complementary diagnostic assay to support Bristol-Myers Squibb's Opdivo anti-PD-1 therapy for non-squamous non-small cell lung cancer. Both kits are available through Dako, an Agilent Technologies company.
Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co., Inc., maker of the anti-PD-1 therapy Keytruda (pembrolizumab). Keytruda is approved by the FDA to treat patients with metastatic NSCLC whose tumors express PD-L1 as determined by the companion diagnostic assay and who have disease progression on or after platinum-containing chemotherapy.
PD-L1 IHC 28-8 pharmDx, also by Dako, was approved as a complementary diagnostic to detect PD-L1 protein expression levels and to help physicians determine which patients may benefit most from treatment with Bristol-Myers Squibb's Opdivo (nivolumab). Opdivo has extended indication, from melanoma and non-small cell lung cancer to renal cell cancer.
"The immuno-oncology agents Keytruda and Opdivo have already transformed the cancer care landscape," said Hytham Al-Masri, M.D., CEO and Medical Director of Hematogenix. "The addition of these two tests to our already existing menu of PD-L1 assays helps to identify patients who may benefit from immunotherapy. With the availability of new companion diagnostics, we continue to see how immune therapies can benefit patients across a wide range of tumours."