The Extended RAS panel from Illumina Inc, San Diego, meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology, the College of American Pathologists, the Association for Molecular Pathology, and the American Society of Clinical Oncology.1 The kit is intended for use on the Illumina MiSeqDx system, and enables US laboratories to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Vectibix (panitumumab).

The monoclonal anti-epidermal growth factor receptor (EGFR) antibody is the first to be approved by FDA for use in combination with FOLFOX for first-line treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC).

“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,” says Garret Hampton, PhD, executive vice president of clinical genomics at Illumina. “Through the Extended RAS panel, clinicians will be able to identify patients with wild-type RAS genes who may benefit from treatment with Vectibix. This approval demonstrates Illumina’s ability to bring NGS to clinical diagnostics through the FDA premarket approval process.”

Francis deSouza, Illumina.

Francis deSouza, Illumina.

“As we expand our understanding of the genomic drivers of cancer, next-generation sequencing (NGS) has the potential to transform cancer therapeutics by informing development of targeted therapies and by delivering integrated testing platforms to identify the right therapy for the right patient,” says Francis deSouza, president and CEO of Illumina. “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 NGS in the treatment of patients with cancer.”

For more information, see “Inside Track: Colorectal Cancer Molecular Biomarkers Get a Guideline.”

REFERENCE

  1. Sepulveda AR, Hamilton SR, Allegra CJ, et al. Molecular biomarkers for the evaluation of colorectal cancer: guideline from the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology. J Mol Diagn. 2017;19:187–225; doi: 10.1016/j.jmoldx.2016.11.001.