Illumina, Inc. (NASDAQ:ILMN) today announced it has formed collaborative
partnerships with leading pharmaceutical companies to develop a
universal next-generation sequencing (NGS)-based oncology test system.
The system will be used for clinical trials of targeted cancer therapies
with a goal of developing and commercializing a multi-gene panel for
therapeutic selection, resulting in a more comprehensive tool for
precision medicine. Initial strategic partners include AstraZeneca,
Janssen Biotech, Inc., and Sanofi (EURONEXT: SAN and NYSE: SNY).
Illumina is working with the strategic partners to develop assays that
detect and measure multiple variants simultaneously to support partners'
clinical trials, with the objectives of securing regulatory agency
approvals and test commercialization. In parallel, Illumina is working
with key thought leaders to set standards for NGS-based assays in
routine clinical oncology practice, as well as to define regulatory
frameworks to enable this new testing paradigm. Together, Illumina and
its strategic partners aim to transition from single-analyte companion
diagnostics to panel-based assays that select for "companion
"The transition to patient-centered companion therapeutics marks a new
era for oncology, and we are pleased to see pharmaceutical companies
working with Illumina on a universal platform to bring life-saving
treatments through their development pipelines," said Ellen V. Sigal,
Ph.D., Chair and Founder of Friends of Cancer Research. "This is the
type of collaboration that will make real progress for patients."
Ruth March, Vice President, Personalised Healthcare & Biomarkers at
AstraZeneca, said, "This partnership has the potential to deliver an
unprecedented amount of clinical information from a single test.
Illumina's technology will inform doctors about the molecular make-up of
their patients' tumors, enabling them to mach medicines to the drivers
of disease. Our aim is that doctors can use these tests to prescribe the
right drugs to the right patients - bringing benefits to healthcare
professionals, payers and patients alike."
To date 125 known cancer driver genes have been discovered - 71 tumor
suppressors and 54 oncogenes - that drive tumor growth through 12
cellular signaling pathways.1 While today the number of
available targeted therapies is limited, an estimated 800 oncology drugs
are in development, many of which are designed to target specific
mutations. With the emergence of new targeted therapies, there is
growing need for new companion diagnostic tests.
"Building on our experience with the MiSeqDx, the only FDA-cleared NGS
platform, as well as the additional regulatory expertise we gained with
the acquisition of Myraqa, Illumina is developing the universal test
system to support our partners' oncology drug pipelines," said Rick
Klausner, M.D., Illumina's Chief Medical Officer. "These agreements
represent the deep engagement between Illumina and the pharma community
to create the technical, clinical, regulatory and ultimately commercial
solutions for the next generation of molecular oncology. We're excited
to be working together to maximize benefits to patients with cancer."
For more information, visit www.illumina.com/precisionmedicine.
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.
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 release.
B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA, et al. (2013) Cancer
Genome Landscapes. Science 339: 1546-1548.
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