Agilent PD-L1 Assay Receives FDA Approval for Use as a Companion Diagnostic


Agilent Technologies Inc. announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer (NSCLC).

Now, physicians will be able to use the PD-L1 IHC 28-8 pharmDx assay as an aid in identifying patients with metastatic NSCLC for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb. Based on the results of the Phase 3 CheckMate -227 clinical trial, Opdivo in combination with Yervoy was approved as first-line treatment for patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test.

Agilent developed PD-L1 IHC 28-8 pharmDx in 2016 through a collaboration with Bristol Myers Squibb, and it has been previously approved as a complementary in vitro diagnostic for non-squamous non-small cell lung cancer, as well as other forms of cancer, including, squamous cell carcinoma of the head and neck, and urothelial carcinoma.

Read more about this news here.

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