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CRCdx® RAS Mutation Detection Kit

"EntroGen Inc...announced today that its CRCdx® RAS Mutation Detection Kit has received national coverage from the US Centers for Medicare & Medicaid Services (CMS). This milestone significantly enhances access to precision oncology for Medicare beneficiaries diagnosed with colorectal cancer, enabling broader adoption of CRCdx® nationwide."

"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."