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Illumina Receives FDA Approval for Companion Dx to Run on MiSeqDx

This article has been corrected to note that Illumina's test is the third NGS-based companion diagnostic to be approved by the FDA, not the second as previously reported.

NEW YORK (GenomeWeb) – Illumina 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.

Last December the agency approved Foundation Medicine's FoundationFocus CDxBRCA test to identify advanced ovarian cancer patients who have mutations in their BRCA1 and BRCA2 genes and are therefore more likely to benefit from Clovis Oncology's PARP inhibitor Rubraca (rucaparib). 

And last week the FDA approved a test developed by Thermo Fisher Scientific in collaboration with AstraZeneca, Pfizer, and Novartis, to identify non-small cell lung cancer patients who are best responders to those pharmaceutical companies' respective drugs.

Garret Hampton, Illumina's executive vice president of Clinical Genomics, said in a statement that having an FDA-approved NGS-based test "enables labs to implement an in-house solution for precision oncology and signifies that NGS has reached a milestone as a clinical diagnostic platform to aid therapeutic decision-making in oncology."

Illumina CEO Francis deSouza added that the approval "paves the way for broader-based genomics solutions and brings us closer to realizing the promise of next generation sequencing in the treatment of patients with cancer."