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FDA Approves Entrogen's RAS Mutation Detection Kit as CDx for Vectibix

NEW YORK – Molecular diagnostics company EntroGen announced on Tuesday that its CRCdx RAS Mutation Detection Kit received US Food and Drug Administration premarket approval as a companion diagnostic for Amgen's Vectibix (panitumumab).

The CRCdx RAS Mutation Detection Kit detects KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients, identifying those most likely to benefit from Vectibix, an intravenous targeted therapy used to treat wild-type RAS metastatic colorectal cancer.

The assay is the first approved real-time PCR-based test in the US that fully meets the biomarker identification requirement for Vectibix.

"We expect CRCdx to improve access to RAS testing at small and midsize laboratories by simplifying the testing procedure while improving the turnaround time and lowering the diagnostic costs," EntroGen CEO Matthew Minkovsky said in a statement.