EntroGen announces CE-IVD marking of its comprehensive Colorectal Cancer DNA panel and Thyroid Cancer kits

Los Angeles, California – March 20, 2017 — Today EntroGen Inc. announced CE-IVD marking of its Colorectal Cancer Panel (CRC), Thyroid Cancer Mutation Analysis kit (THDNA), and Thyroid Cancer Fusion Gene Detection kit (THRNA).

The CRC panel is a highly multiplexed polymerase chain reaction (PCR)-based assay that enables rapid and simultaneous screening of 50 somatic mutations in 5 oncogenes associated with colorectal cancer tumors: KRAS NRAS, BRAF, PIK3CA, and AKT.  The CRC panel kit meets the latest published guidelines from CAP, ASCO, AMP, and ASCP and is compatible with formalin fixed paraffin embedded (FFPE) and fresh frozen tissue. It also includes data analysis software for automated reporting and sample quality assessment reagents designed to optimize sample input and avoid common run failures when using DNA isolated from formalin fixed tissues.

The THDNA and THRNA kits are multiplexed PCR-based assays that prevent unnecessary surgeries due to indeterminate cytology specimens by detecting molecular markers associated with malignant thyroid tumors. THDNA detects point mutations in BRAF, KRAS, NRAS, and HRAS in isolated DNA whereas THRNA detects the chromosomal translocations RET/PTC1, RET/PTC3, and PAX8/PPARγ in RNA. Both kits are compatible with FFPE, fine needle aspiration (FNA), and fresh frozen samples.

CRC, THDNA, and THRNA are validated for several leading real time PCR instruments pervasive in laboratories today and produce results in under 3 hours.

 

About EntroGen

Based in Los Angeles, California, EntroGen (http://www.entrogen.com) is a biotechnology company with a focus on molecular diagnostic products in the areas of hematology and oncology. EntroGen has a growing commercial portfolio with many of its products being used to guide and monitor targeted therapies for various malignancies.  EntroGen’s footprint reaches every corner of the globe delivering reliable clinical and research products.