On October 3, 2023 The U.S. Food and Drug Administration (FDA) reported that it 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 (Press release, EntroGen, OCT 3, 2023, View Source [SID1234635606]). 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.

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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 the diagnostic costs," said Matthew Minkovsky, CEO of EntroGen. "CRCdx is available immediately," he added.