COMPANY:

EntroGen

"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."

"EntroGen, Inc. announces the immediate availability of its new NGS Targeted Hotspot Panel (THSP) designed to detect the most clinically relevant hotspot mutations in 16 genes across diverse tumor types. The panel is compatible with Illumina® MiniSeq, MiSeq and NexSeq 500. The company is obtaining a CE-IVD marking in the EU for the NGS Targeted Hotspot Panel. It is currently available worldwide for research use only."