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. This landmark premarket approval (PMA) marks a significant advancement in precision medicine for colorectal cancer patients in that CRCdx® is the first approved real-time PCR-based test in the U.S. that fully meets the biomarker identification requirement for Vectibix®.

The CRCdx® RAS Mutation Detection Kit is a cutting-edge molecular diagnostic tool designed to accurately detect KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients. The kit’s high sensitivity and specificity enable clinicians to quickly and easily identify patients most likely to benefit from Vectibix® therapy and avoid unnecessary side effects and costs from treatment.

“We expect CRCdx® to improve access to RAS testing at small and mid-size laboratories by simplifying the testing procedure while improving the turnaround time and lowering


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