Illumina Announces Next-Generation Sequencing Cancer Companion Diagnostic Test Kit

Illumina recently 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). 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
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. “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 Panelpaves 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