Illumina has unveiled its new FDA-approved next-generation sequencing (NGS) kit, the Extended RAS Panel.

It is intended to be used on the llumina MiSeqDx System and enables U.S. laboratories to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Vectibix.

The kit meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology (AMP), and the American Society of Clinical Oncology (ASCO). 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 original 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 optimize 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,” said Garret Hampton, PhD, executive vice president of clinical genomics at Illumina.

“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.”

Francis deSouza, president and CEO of Illumina, added, “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.

“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 realising the promise of next generation sequencing in the treatment of patients with cancer.”

The Extended RAS Panel offers:

  • Meets Current Colorectal Cancer Guidelines – The content of this product satisfies the most up-to-date guidance for RAS testing to determine eligibility for EGFR inhibitors in metastatic colorectal cancer.
  • Integrated Workflow – Comprehensive diagnostic solution includes library prep, sequencing, and clinical report.
  • Extended Gene Coverage – Simultaneous detection of 56 RAS mutations contraindicated for anti-EGFR therapy.