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.
The approval marks just the second NGS-based companion diagnostic that the FDA has approved. Last week, the agency 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.”