Affymetrix Receives Grant for Non-Invasive Genomic Profiling of Bladder Cancer
March 08 2016 - 5:30AM
Business Wire
Affymetrix Inc. (NASDAQ:AFFX) today announced that it has
received a grant from Innovate UK (IUK) to demonstrate the health
and economic value of utilizing the company’s OncoScan® FFPE Assay
Kit for non-invasive genomic profiling of bladder cancer from urine
samples. Bladder cancer is the seventh most common cancer in the
western world, with over 10,000 new cases diagnosed in the UK each
year. Patients with non-muscle invasive bladder cancer (NMIBC)
generally have greater than 90 percent survival rates over five
years, but high recurrence rate and significant risk of progression
to muscle invasive bladder cancer (MIBC) require continual
monitoring. Current bladder cancer monitoring methods rely on
repeat cystoscopy and biopsy. These procedures are highly invasive,
unpleasant for the patient, and expensive for the healthcare
system.
With the grant, Affymetrix will develop a health and economic
benefits assessment for replacing surveillance cystoscopies with
non-invasive genomic profiling from urinary cell-free DNA (cfDNA)
using the OncoScan assay. Identifying genomic changes in a
non-invasive fashion would allow for improved patient well-being as
well as delivering significant cost savings for the UK National
Health System (NHS).
The successful grant application was supported by research led
by Dr. Richard Bryan from the University of Birmingham and an IUK
Stratified Medicine Innovation Platform grant led by Prof. Mike
Griffiths from the West Midlands Regional Genetics Laboratory. This
research has demonstrated that key genomic aberrations evident in
bladder tumor biopsy material can also be detected in urinary cfDNA
with the OncoScan assay, even for very early stage NMIBC tumors.
This work, examining a cohort of 23 patients with confirmed
urothelial bladder cancer (UBC) was published recently in the
European Journal of Human Genetics. The team showed that cfDNA from
UBC patients is highly representative of the tumor genome and has a
consistently higher tumor burden than DNA from exfoliated whole
cells found in urine cell pellets, thereby allowing greater
detection of important tumor-specific biomarkers. Dr. Bryan stated,
"Although the majority of non-invasive tests for bladder cancer
currently in use or being researched seem to rely upon
the DNA extracted from the cells found in urine, we have shown that
the cell-free DNA from the remainder of the urine is much more
representative of the actual tumor, and so potentially more
accurate. This opens up so many new and unexplored avenues for
the millions of bladder cancer patients worldwide who are waiting
for a revolution in their treatment and follow-up. This is really
exciting. We will continue to explore these avenues through
follow-on funding from Innovate UK, and will continue to work with
Affymetrix to try to achieve this goal."
Following a favorable assessment of likely benefits for the NHS,
Affymetrix will seek additional grant funding to test the OncoScan
assay’s clinical performance and its ability to stratify patients
who are likely to progress to MIBC compared to cystoscopy.
“We are pleased to have the opportunity to demonstrate the cost
effectiveness and utility of the OncoScan platform,” said Andy
Last, chief operating officer at Affymetrix. “The promise of a
non-invasive, comprehensive, whole-genome profile offers the
potential to advance the way bladder cancer is monitored and
treated, as well as greatly reduce the monitoring burden for
patients.”
For more information about Innovate UK, please visit
https://www.gov.uk/government/organisations/innovate-uk/about
About Affymetrix
Affymetrix technologies enable multiplex and simultaneous
analysis of biological systems at the cell, protein, and gene
level, facilitating the rapid translation of benchtop research into
clinical and routine use for human health and wellness. Affymetrix
provides leadership and support, partnering with customers in
pharmaceutical, diagnostic, and biotechnology companies as well as
leading academic, government, and nonprofit research institutes in
their quest to use biology for a better world. More than 2,300
microarray systems have been shipped around the world and more than
94,000 peer-reviewed papers have been published citing Affymetrix
technologies. Affymetrix is headquartered in Santa Clara,
California, and has manufacturing facilities in Cleveland, San
Diego, Vienna, and Singapore. Affymetrix has about 1,100 employees
and maintains sales and distribution operations worldwide. For more
information about Affymetrix, please visit www.affymetrix.com.
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, 2015, and other SEC reports for subsequent
quarterly periods.
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.
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