REDWOOD CITY, Calif. and
SAN DIEGO, July 7, 2016 /PRNewswire/ -- Genomic Health,
Inc. (Nasdaq: GHDX) and Epic Sciences, Inc. today announced an
exclusive agreement to commercialize Epic Sciences' novel AR-V7
liquid biopsy test in the United
States through Genomic Health's world-class commercial
channel. The blood-based test detects the V7 variant of the
androgen receptor protein (AR-V7) in the nucleus of circulating
tumor cells (CTC) – information that can help guide treatment
selection in patients with metastatic castration-resistant prostate
cancer (mCRPC).
AR-V7 expression has been associated with resistance to hormone
therapy drugs called androgen receptor signaling (ARS) inhibitors.
A recently published study in JAMA Oncology from Memorial
Sloan Kettering Cancer Center demonstrated that mCRPC patients with
AR-V7 positive CTCs had significantly better clinical outcomes when
treated with taxane chemotherapy, which suggests that patients with
detectable blood levels of AR-V7 should consider life prolonging
chemotherapy as an alternative to potentially less effective and
more expensive hormonal treatment with ARS drugs. These study
results underscore the potential for an AR-V7 predictive test to
allow advanced prostate cancer patients to avoid ineffective
therapies and to receive chemotherapy at an earlier stage when it
may be more beneficial.
"The validation study published in JAMA Oncology
demonstrated that patients with AR-V7 positive CTCs have longer
survival on taxane chemotherapy relative to those on AR signaling
inhibitors," said Dr. Howard Scher,
M.D., study principal investigator and chief of Genitourinary
Service at Memorial Sloan Kettering Cancer Center, New York. "The growing body of evidence for
the clinical utility of AR-V7 supports its use in clinical practice
as a treatment-specific biomarker to guide treatment selection for
patients with advanced prostate cancer."
Virtually all men with metastatic prostate cancer eventually
develop mCRPC, an advanced stage of the disease where the standard
of care includes abiraterone, enzalutamide and taxanes. It is
estimated that each year, about 50,000 mCRPC patients could benefit
from knowing their AR-V7 status prior to selecting further
treatment. With the use of this new test, the two companies
estimate substantial healthcare savings per patient tested by
tailoring treatment selection.
"Epic Sciences' no cell left behind® platform
offers the highest clinical sensitivity and specificity for nuclear
AR-V7 characterization. This enables a best-in-class test that
provides clinically actionable information that can directly affect
patient outcomes and health economics," said Murali Prahalad, president and chief executive
officer, Epic Sciences. "The Epic Sciences AR-V7 test is the first
of many groundbreaking tests we are developing, and our
collaboration with Genomic Health is an important milestone to
realize its commercial potential with a world-class partner."
"This strategic collaboration allows us to leverage our
successful commercial channel while continuing to generate growth
across our business," said Frederic
Pla, Ph.D., chief business and product development officer,
Genomic Health. "Epic Sciences' industry leading CTC-based platform
enables the delivery of clinically actionable information to
prostate cancer patients at a critical treatment decision point.
Offered as part of our Oncotype IQ™ Genomic Intelligence Platform
that collectively assesses DNA, RNA, and protein using either PCR,
NGS, or image-based analysis, Epic Sciences' AR-V7 test will
complement our expanding portfolio, which also includes Oncotype
SEQ™, our recently launched liquid biopsy mutation panel."
Based on the agreement, Genomic Health will have exclusive
distribution rights to market and sell the new Epic Sciences liquid
biopsy test in the U.S. beginning in early 2017. The test will be
offered through Genomic Health's commercial channel to enable
physicians to order the test and view the results through the
current physician portal. The test will be performed by Epic
Sciences at its centralized, CLIA-certified laboratory in
San Diego, Calif.
As part of the agreement, Genomic Health will make an equity
investment in Epic Sciences. Further financial terms will not be
disclosed at this time.
About Genomic Health
Genomic Health, Inc.
(NASDAQ: GHDX) is the world's leading provider of genomic-based
diagnostic tests that address both the overtreatment and optimal
treatment of cancer, one of the greatest issues in healthcare
today. With its Oncotype IQ™ Genomic Intelligence Platform, the
company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of clinical
and genomic big data into actionable results for treatment
planning throughout the cancer patient journey, from diagnosis to
treatment selection and monitoring. The Oncotype IQ portfolio
of genomic tests and services currently consists of the company's
flagship line of Oncotype DX gene expression tests that have been
used to guide treatment decisions for more than 600,000 cancer
patients worldwide. Genomic Health is expanding its test
portfolio to include additional liquid and tissue-based tests. The
company is based in Redwood City, California, with
international headquarters in Geneva, Switzerland. For
more information, please visit, www.GenomicHealth.com and
follow the company on
Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
About Epic Sciences
Epic Sciences, Inc. is developing
novel diagnostics to personalize and advance the treatment and
management of cancer. Epic Sciences' mission is to enable the rapid
and non-invasive detection of genetic and molecular changes in
cancer throughout a patient's journey. The company was founded on a
powerful platform to identify and characterize rare cells,
including circulating tumor cells (CTCs). Epic Sciences' no cell
left behind® technology helps match patients to targeted
therapies and monitor for drug resistance, so that the best
treatment path can be chosen at every clinical decision point.
Today, we partner with leading pharmaceutical companies and major
cancer centers around the world. Epic Sciences' goal is to
commercialize our technology to increase the success rate of cancer
drugs in clinical trials and improve patient outcomes by providing
physicians real-time information to guide treatment choices.
Further information is available on the Company's
website,www.epicsciences.com. Stay in touch on LinkedIn Epic
Sciences, on Twitter@EpicSciences or on
Facebook.com/EpicSciences.
This press release contains forward-looking statements
about Genomic Health, Inc. within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are subject to risks and uncertainties that could cause
actual results to differ materially, and reported results should
not be considered as an indication of future performance. These
risks and uncertainties include, but are not limited to Genomic
Health's: business model; the regulation of Genomic Health's tests
or any tests offered through its commercial channel; the
applicability of clinical study results to actual outcomes; Genomic
Health's ability to develop, commercialize or collaborate to offer
any new tests in new markets domestically and internationally; the
risk that sufficient levels of reimbursement may not be obtained or
maintained, domestically or abroad, for Genomic Health's tests or
tests offered through its commercial channel; competition;
unanticipated costs or delays in research and development efforts;
Genomic Health's ability or the ability of its collaborators to
obtain capital when needed to support the activities contemplated
by the collaboration; and the other risks and uncertainties set
forth in Genomic Health's filings with the Securities and Exchange
Commission, including the risks set forth in Genomic Health's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. These forward-looking statements
speak only as of the date hereof. Genomic Health disclaims any
obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype SEQ, and
Oncotype IQ are trademarks or registered trademarks of Genomic
Health, Inc. The Epic Sciences logo and no cell left behind is a
trademark or registered trademark of Epic Sciences, Inc. All other
trademarks and service marks are the property of their respective
owners.
Logo - http://photos.prnewswire.com/prnh/20160706/386935LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/genomic-health-and-epic-sciences-announce-strategic-collaboration-to-deliver-novel-ar-v7-liquid-biopsy-test-to-predict-treatment-response-in-metastatic-prostate-cancer-300295092.html
SOURCE Genomic Health, Inc.