Hematogenix FDA Approved PD-L1 Companion Diagnostic Test
Hematogenix Laboratory Services is offering two US Food and Drug Administration approved PD-L1 companion diagnostic assays: PD-L1 IHC 22C3 pharmDx for Keytruda and PD-L1 IHC 28-8 pharmDx. Dako, an Agilent company, developed PD-L1 IHC 22C3 pharmDx Keytruda in partnership with Merck. Keytruda is approved by the FDA to treat patients with metastatic non-small cell lung cancer whose tumors express PD-L1 and have disease progression on or after platinum-containing chemotherapy. PD-L1 IHC 28-8 pharmDx, also developed by Dako, was approved as a companion diagnostic for Bristol-Myers Squibb's Opdivo, to detect PD-L1 protein expression levels and to help physicians determine which patients may benefit most from treatment with the therapy. Both kits are available through Dako.