Illumina announces FDA-approved NGS cancer companion test kit

Illumina has announced its Extended RAS Panel, an FDA-approved next-generation sequencing (NGS) kit.

This kit is intended to be used on the Illumina MiSeqDx System and enables laboratories to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Vectibix (panitumumab).

As 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), Vectibix represents an innovative treatment option for these patients. 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 optimise cancer treatment planning.

“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,” shared Garret Hampton, PhD, Executive Vice President, Clinical Genomics at Illumina.

“As we expand our understanding of the genomic drivers of cancer, next-generation sequencing 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,” said Francis deSouza, President and CEO of Illumina.