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FDA Approves Agilent Complementary Dx for Two Additional Indications

NEW YORK (GenomeWeb) – Agilent Technologies announced today that the US Food and Drug Administration has approved its Dako PD-L1 IHC 28-8 pharmDx complementary diagnostic for two additional indications: urothelial carcinoma (UC) and squamous cell carcinoma of the head and neck (SCCHN).

The test is a complementary diagnostic for Bristol-Myers Squibb's cancer drug Opdivo (nivolumab). It was approved by the FDA in October 2015 as a complementary diagnostic to Opdivo for the non-squamous non-small cell lung cancer indication, and then received expanded approval from the FDA for melanoma in January 2016.

For the new indications, the test enables physicians to identify which patients with locally advanced or metastatic UC and recurrent or metastatic SCCHN who have disease progression on or after platinum-based chemotherapy would most likely benefit from treatment with Opdivo, Agilent said.

"I am delighted that this approval by the FDA enables our products to help inform better patient selection for these very distressing cancers," Jacob Thaysen, president of Agilent's diagnostics and genomics group, said in a statement. "Agilent's Dako brand of innovative pathology diagnostics seek to deliver results that pathologists can trust. Our rigorous design process ensures that evidence is based not only on analytical validation but also clinical validation by inclusion in our partner's clinical trials."