PD-L1 IHC 28-8 pharmaDx assay
Laboratory Corporation of America announced US availability of the PD-L1 IHC 28-8 pharmaDx assay as a complementary diagnostic for two newly approved indications in connection with the use of Bristol-Myers Squibb's Opdivo. For both of the new indications – metastatic urothelial carcinoma, also referred to as bladder cancer, and squamous cell carcinoma of the head and neck – Opdivo is approved for treatment without the use of the test, but the test provides physicians with information about the patients who are most likely to respond positively to the treatment. LabCorp's Center for Molecular Biology and Pathology laboratory performed testing for the clinical studies that supported approval of the new indications for the assay. The assay was developed by Agilent's Dako pathology division. The assay was previously approved for use as a complementary diagnostic with Opdivo to treat non-squamous non-small cell lung cancer and melanoma.