EntroGen Secures US FDA Nod For CRCdx RAS Mutation Detection Kit

The US Food and Drug Administration (FDA) has approved EntroGen's CRCdx RAS Mutation Detection Kit as a companion diagnostic for Vectibix (panitumumab), a colorectal cancer targeted therapy. This historic premarket approval (PMA) represents a significant step in precision medicine for colorectal cancer patients since CRCdx is the first authorized real-time PCR-based test in the US that completely passes the Vectibix biomarker identification criterion.

The CRCdx RAS Mutation Detection Kit is a cutting-edge molecular diagnostic tool developed to identify KRAS and NRAS exon 2, 3, and 4 mutations in individuals with colorectal cancer. Because of the kit's high sensitivity and specificity, doctors may quickly and easily identify patients who are most likely to benefit from Vectibix medication and minimize unwanted side effects and treatment expenses, as per pharmabiz.

"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. EntroGen is a renowned biotechnology company that provides end-to-end molecular diagnostics solutions for cancer and hematology through automation, reagents, and software. EntroGen solutions are meant to be accurate, affordable, and scalable, beginning with automated nucleic acid extraction and ending with genomic interpretation, using proprietary software incorporated throughout the whole workflow.