Affymetrix, Inc. (NASDAQ: AFFX) announced the launch of the new
OncoScan™ FFPE Assay Kit, a whole-genome copy number assay for
highly degraded FFPE solid tumor samples, at the Cancer
Cytogenomics Microarray Consortium conference being held in Chicago
this week.
Despite the growing need of cancer researchers and clinicians,
obtaining high-quality, whole-genome copy number data from degraded
FFPE-derived tumor DNA has remained extremely challenging due to
the limitations of current methods such as FISH, array CGH, and
next-generation sequencing technologies.
The new OncoScan FFPE Assay Kit, utilizing Affymetrix’ unique
Molecular Inversion Probe (MIP) technology, is capable of analyzing
small amounts of highly degraded DNA from FFPE samples quickly and
affordably, providing a significant step forward in solid tumor
cancer analysis.
This new product provides whole-genome copy number data with
specifically enhanced high resolution in approximately 900 known
cancer genes, loss of heterozygozity (LOH) across the whole genome
as well as clinically relevant somatic mutation data − all from a
single assay. An updated version of BioDiscovery’s Nexus software,
OncoScan™ Nexus Express Software, enables copy number calls for
hundreds of samples in minutes and will be included with the
product.
The new kit was successfully tested earlier this year in leading
cancer research institutes, including M. D. Anderson Cancer Center,
Memorial Sloan Kettering Cancer Center, and ARUP Laboratories.
“We performed testing of the new OncoScan™ FFPE Assay Kit at
ARUP on multiple solid tumor tissues, including melanoma, glioma,
breast carcinoma, and liposarcoma,” commented Sarah South, Medical
Director at ARUP Laboratories. “We used the recommended 80 ng of
DNA from FFPE and were able to complete the assay over a 48-hour
period. We were able to detect FISH-confirmed aberrations in
several key cancer genes including ERBB2, MDM2, EGFR, and MYC
suggesting that OncoScan FFPE Assay Kit can be considered a viable
higher resolution and higher specificity alternative to FISH
testing for confirmation of cancer gene aberrations in solid tumor
tissue. Because OncoScan FFPE Assay Kit has whole-genome
resolution, we also obtained valuable incremental copy number
aberrations in these samples.”
Professor Torsten Pietsch, MD, PhD, Institute of Neuropathology,
University of Bonn observed that based on his experience with a
large cohort of FFPE brain tumor samples, “We believe that the
OncoScan FFPE Assay Kit is a robust platform for the rapid
discovery and validation of novel prognostic copy number
signatures, that may also be useful in a clinical setting for the
detection of specific gains in tumors as markers for patient
stratification.”
“The significance of copy number aberrations is being
established in an ever increasing number of genes; however, few
studies have realized this potential for solid tumors because of
the challenges of working with low-input FFPE samples,” said Andy
Last, Executive Vice President of the Genetic Analysis and Clinical
Applications Business Unit at Affymetrix. “OncoScan FFPE Assay Kit
is a game changer for cancer laboratories that want to quickly and
affordably analyze hundreds of degraded FFPE samples to correlate
copy number aberrations with outcomes data. In addition, the
ability to detect a range of clinically relevant somatic mutations
adds even more value to the assay and analysis.”
The technology has previously been made available via the
OncoScan™ FFPE Express 2.0 Service from the Affymetrix Research
Services Laboratory and has demonstrated an unparalleled success
rate, with more than 70 publications in the last two years. The
platform enables detection in highly degraded samples unlocking a
wealth of stored information in FFPE archives of ten years and
older.
Affymetrix is accepting orders immediately and will begin
shipping the product as early as September this year.
PLEASE NOTE: Affymetrix®, the Affymetrix logo, and OncoScan™
trademarks are the property of Affymetrix, Inc. All other
trademarks are the property of their respective owners.
Products mentioned in this release are for research use only.
Not for diagnostic procedures.
SOURCE: Affymetrix, Inc.
Forward-looking statements
All statements in this press release that are not historical are
"forward-looking statements" within the meaning of Section 21E of
the Securities Exchange Act as amended, including statements
regarding Affymetrix' "expectations," "beliefs," "hopes,"
"intentions," "strategies," or the like. Such statements are
subject to risks and uncertainties that could cause actual results
to differ materially for Affymetrix from those projected. These and
other risk factors are discussed in Affymetrix' Form 10-K for the
year ended December 31, 2012, and other SEC reports for subsequent
quarterly periods.
About Affymetrix
Affymetrix technologies enable multiplex and simultaneous
analysis of biological systems at the cell, protein, and gene
level, facilitating the rapid translation of bench-top research
into clinical and routine use for human health and wellness.
We strive to provide leadership and support, partnering with our
customers in pharmaceutical, diagnostic, and biotechnology
companies, as well as leading academic, government, and non-profit
research institutes in their quest for answers toward using biology
for a better world.
More than 2,300 microarray systems have been shipped around the
world and more than 48,000 peer-reviewed papers have been published
citing our technologies. Affymetrix is headquartered in Santa
Clara, California, and has manufacturing facilities in Cleveland,
Ohio, San Diego, Vienna and Singapore. The Company has about 1,100
employees worldwide and maintains sales and distribution operations
across Europe, Asia, and Latin America. For more information about
Affymetrix, please visit www.affymetrix.com.
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