EntroGen Receives FDA Approval for CRCdx® RAS Mutation Detection Kit as Companion Diagnostic for Vectibix®

The U.S. Food and Drug Administration (FDA) has granted approval for EntroGen’s CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix® (panitumumab), a targeted therapy used in the treatment of colorectal cancer. The company claims that the premarket approval (PMA) makes CRCdx® the first approved real-time PCR-based test in the U.S. to fully meet the biomarker identification requirement for Vectibix®.

The CRCdx® RAS Mutation Detection Kit is a molecular diagnostic tool specifically designed to accurately detect KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients.

The U.S. Food and Drug Administration (FDA) has granted approval for Vectibix (panitumumab) to be used in combination with FOLFOX as a first-line treatment for patients with wild-type KRAS metastatic colorectal cancer. As part of the approval, the FDA approved the therascreen KRAS RGQ PCR Kit, developed by Qiagen N.V., as a companion diagnostic for Vectibix when it approved the drug for the first line indication. This diagnostic test detects the most common mutations in the KRAS gene.

Matthew Minkovsky, CEO of EntroGen, expressed his expectation that CRCdx® will enhance access to RAS testing, particularly in small and mid-size laboratories where access to an FDA approved kit simplifies the testing procedure.