Illumina Offers FDA-Approved NGS Cancer Companion Test Kit

 | Jul 02, 2017 10:56PM ET

Global leader in the field of DNA sequencing and array-based technologies, Illumina, Inc. (NASDAQ:ILMN) recently announced that its FDA-approved next-generation sequencing (NGS) -- Extended RAS Panel has met the Current Colorectal Cancer Guidelines. This new kit fulfills the most up-to-date guidance for RAS testing to determine eligibility of epidermal growth factor receptor (EGFR) inhibitors in metastatic colorectal cancer. This product also offers extended gene coverage that implies the simultaneous detection of 56 RAS mutations contraindicated for anti-EGFR therapy. This product also helps in Integrated Workflow by providing comprehensive diagnostic solution which includes library prep, sequencing and clinical report.

This Extended RAS Panel kit is intended to be used on the Illumina MiSeqDx System to detect patients who are eligible for metastatic colorectal cancer treatment with Vectibix. Notably, Vectibix represents an innovative treatment option for first-line treatment for patients with wild-type RAS metastatic colorectal cancer (mCRC).

Per management, the Extended RAS Panel paves the way for broader-based genomics solutions as a first companion diagnostic and Pre-Market Application (PMA) approval in Oncology. The shipment of this kit will start in the third quarter of 2017.

According to Markets and Markets, the global next-generation sequencing market is estimated to reach a worth of $12.45 billion by 2022, at a CAGR of 20.5%.