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Illumina Granted FDA Approval for Next-Generation Sequencing Cancer Companion Diagnostic Test Kit

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ:ILMN) today announced its Extended RAS Panel, an FDA-approved next-generation sequencing (NGS) kit that meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO)1. 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).*

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 optimize cancer treatment planning2 3.

“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. “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.”

“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. “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.”

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

The Extended RAS Panel will begin shipping in Q3 2017. For more information, please visit www.illumina.com/ExtendedRASPanel.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.


*Vectibix is a registered trademark of Amgen, Inc.

1 Sepulveda AR, Hamilton SR, Allegra CJ, Grody W, Cushman-Vokoun AM, Funkhouser WK, 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.
2 Sorich MJ, Wiese MD, Rowland A, Kichenadasse G, McKinnon RA, Karapetis CS. Extended RAS mutations and anti-EGFR monoclonal antibody survival benefit in metastatic colorectal cancer: a meta-analysis of randomized, controlled trials. Ann Oncol. 2015 Jan;26(1):13-21.
3 US NCCN Guidelines: Colon Cancer V.1.2017

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