By Diagnostics World News Staff
June 30, 2017 | Illumina has announced FDA approval of its Extended RAS Panel for use on the MiSeqDx System. The next-generation sequencing (NGS) kit is intended to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Amgen’s Vectibix (panitumumab).
The Extended RAS Panel meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO)1. This kit is intended to be used on the Illumina MiSeqDx System, and will begin shipping in Q3 2017.
"Together with Amgen, we've developed a companion diagnostic test kit that interrogates 56 variants across the KRAS and NRAS genes in order to establish mutant status in a single test. Through the Extended RAS Panel, clinicians will be able to identify patients with wild-type RAS genes who may benefit from treatment with Vectibix," said Garret Hampton, PhD, Executive Vice President, Clinical Genomics at Illumina in a press release. "This approval demonstrates Illumina's ability to bring NGS to clinical diagnostics through the FDA Pre-Market Application (PMA) process. The Extended RAS Panel on the MiSeqDx System enables labs to implement an in-house solution for precision oncology and signifies that NGS has reached a milestone as a clinical diagnostic platform to aid therapeutic decision-making in oncology."
Vectibix is the first monoclonal anti-epidermal growth factor receptor (EGFR) antibody approved by the FDA for use in combination with FOLFOX for first-line treatment for patients with wild-type RAS metastatic colorectal cancer (mCRC). The improvement of both overall survival and progression free survival seen with Vectibix in combination with FOLFOX in patients with wild-type RAS mCRC highlights the importance of expanded biomarker screening to optimize cancer treatment planning.
The Extended RAS Panel is a comprehensive diagnostic solution that includes library prep, sequencing, and clinical report. It simultaneous detects 56 RAS mutations contraindicated for anti-EGFR therapy.
"As our first companion diagnostic and PMA approval in Oncology, the Extended RAS Panel paves the way for broader-based genomics solutions and brings us closer to realizing the promise of next generation sequencing in the treatment of patients with cancer," said Francis deSouza, President and CEO of Illumina in the same statement.