Amgen and Illumina Enter Agreement to Develop Oncology Companion Diagnostic Test

  Amgen and Illumina Enter Agreement to Develop Oncology Companion Diagnostic

Illumina to Develop In Vitro Diagnostic (IVD) Kit on its FDA-Cleared MiSeqDx™
Next-Generation Sequencing (NGS) Instrument for Amgen’s Vectibix (Panitumumab)

Business Wire

SAN DIEGO -- January 15, 2014

Illumina, Inc. (NASDAQ:ILMN) today announced it has entered into an agreement
with Amgen Inc. to develop and commercialize a multigene, NGS-based test as a
companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR
monoclonal antibody therapeutic for the treatment of metastatic colorectal
cancer approved in the US and EU. Under the terms of the collaboration,
premarket approval of the test by the US Food and Drug Administration (FDA)
and other regulatory bodies will be sought. The test will be developed for use
with Illumina's MiSeqDx™ instrument, which received premarket clearance from
the FDA on November 19, 2013 and was CE-marked for the European Union on July
16, 2013.

The collaboration will seek to validate a test platform that can identify RAS
mutation status of patients who would be appropriate to receive Vectibix.
Following CE marking and FDA approval, Illumina plans to commercialize the
test with a focus on US and EU markets. This collaboration also demonstrates
Illumina’s commitment to partnering with therapeutics companies and to
bringing its leading NGS technologies into oncology care.

“This collaboration is consistent with our strategy to bring the power of NGS
to clinical diagnostics,” said Nick Naclerio, Senior Vice President of
Corporate and Venture Development and General Manager of Illumina’s Enterprise
Informatics business at Illumina. “With three FDA-cleared NGS products in our
portfolio, we intend to complement internal development programs by taking
products developed with external partners through the FDA submission process.
Amgen is a key partner given their leadership in therapeutic development and
strong track record in commercializing novel products.”

Dr. Rick Klausner, Chief Medical Officer and acting General Manager of
Illumina’s Oncology business, added, “NGS provides an advantage over
traditional technologies that typically detect only one or a few variants.
Multigene NGS panels provide a more complete genetic picture of each patient’s
tumor, which can better inform critical treatment decisions. We see the
development of multigene diagnostic tests as a natural evolution to improve
cancer care and outcomes.”


Illumina( is a leading developer, manufacturer, and marketer
of life science tools and integrated systems for the analysis of genetic
variation and function. We provide innovative sequencing and array-based
solutions for genotyping, copy number variation analysis, methylation studies,
gene expression profiling, and low-multiplex analysis of DNA, RNA, and
protein. We also provide tools and services that are fueling advances in
consumer genomics and diagnostics. Our technology and products accelerate
genetic analysis research and its application, paving the way for molecular
medicine and ultimately transforming healthcare.

Forward-Looking Statements

This release may contain forward looking statements that involve risks and
uncertainties. Important factors that could cause actual results to differ
materially from those in any forward-looking statements are detailed in our
filings with the Securities and Exchange Commission, including our most recent
filings on Forms 10-K and 10-Q, or in information disclosed in public
conference calls, the date and time of which are released beforehand. We do
not intend to update any forward-looking statements after the date of this


Illumina, Inc.
Rebecca Chambers
Jennifer Temple
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