Illumina receives FDA approval for companion Dx to run on MiSeqDx

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illumina-logo2Illumina has received US Food and Drug Administration approval for a companion diagnostic test, which it has been developing with Amgen, to run on its MiSeqDx system, the company said after the close of the market on Thursday.

The Extended RAS Panel analyzes 56 variants in the KRAS and NRAS genes to determine whether patients will benefit from Amgen’s Vectibix (panitumumab), which is approved for patients with metastatic colorectal cancer who have wild-type KRAS and NRAS genes. Illumina will begin shipping the panel in the third quarter.

Illumina and Amgen began collaborating on the test in 2014, and last fall Illumina said it had submitted the test to the FDA for premarket approval.

The approval marks the third NGS-based companion diagnostic that the FDA has approved. Read more …

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