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FDA grants marketing approval to next-generation sequencing test for metastatic colorectal cancer
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The FDA granted marketing approval to the Praxis Extended RAS Panel to detect the presence of 56 specific mutations in RAS genes in tumor tissue of patients with metastatic colorectal cancer.
Praxis Extended RAS Panel (Illumina Inc.), a next-generation sequencing test, is used to help identify patients who may be eligible for treatment with panitumumab (Vectibix, Amgen), a fully human monoclonal antibody specific to the epidermal growth factor receptor.
A retrospective, multicenter trial designed to evaluate panitumumab in combination with FOLFOX as first-line treatment for patients with RAS wild-type metastatic colorectal cancer supported the efficacy of panitumumab for patients whose tumors do not have KRAS or NRAS mutations.
Analytical validation of the Praxis Extended RAS Panel showed it performed consistently and accurately in the detection of the select mutations.
“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,” Francis deSouza, president and CEO of Illumina, said in a company-issued press release. “As our first companion diagnostic and [FDA premarket application] 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.”
The Praxis Extended RAS Panel is intended to be used on the Illumina MiSeqDx System, which meets 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 ASCO.
“The Extended RAS Panel on the MiSeqDx System enables labs to implement an in-house solution for precision oncology and signifies that [next-generation sequencing] has reached a milestone as a clinical diagnostic platform to aid therapeutic decision-making in oncology,” Garret Hampton, PhD, executive vice president of clinical genomics at Illumina, said in the release.