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First cancer CDx for Illumina

July 12, 2017Illumina announced its Extended RAS Panel, an FDA-approved next-generation sequencing kit that meets the published guidelines for evaluation of colorectal cancer from the CAP, American Society for Clinical Pathology, Association for Molecular Pathology, and American Society of Clinical Oncology. This kit is intended to be used on the Illumina MiSeqDx system and enables U.S. laboratories to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Vectibix (panitumumab).

The test kit interrogates 56 variants across the KRAS and NRAS genes to establish mutant status in a single test.

“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,” Francis deSouza, Illumina president and CEO, said in a statement. The panel will begin to ship in the third quarter of this year.

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