REDWOOD CITY, Calif.,
May 21, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced that
Palmetto GBA, a Medicare Administrative Contractor (MAC) that
assesses molecular diagnostic technologies, has issued a draft
local coverage determination (LCD) for the Oncotype DX® prostate
cancer test. The draft LCD recommends coverage of the Oncotype DX
prostate cancer test for qualified Medicare patients throughout
the United States "to help
determine which patients with early-stage, needle biopsy proven
prostate cancer, can be conservatively managed rather than treated
with definitive surgery or radiation therapy."
"We are very pleased with this draft coverage determination. It
is an important step toward ensuring that all prostate cancer
patients covered by Medicare, which represents 50 percent of the
population eligible for our test, have access to the unique
biological information provided by Oncotype DX in order to more
precisely assess their cancer's aggressiveness and for their
physicians to determine the optimal treatment," said Kim Popovits,
chairman of the board, chief executive officer and president of
Genomic Health.
The draft LCD is posted to the Medicare Coverage Database on the
Centers for Medicare and Medicaid Services (CMS) website. It will
go through Medicare's review process, which includes a public
comment period, finalization and notification.
Palmetto's positive draft local coverage decision follows
multiple new Oncotype DX data presentations at the 2015 American
Urological Association Annual Meeting. The results from three
studies documented the real-world positive impact of the Oncotype
DX Genomic Prostate Score (GPS) and the test's value in managing
healthcare costs associated with treatment decisions in low-risk
patients.
With 11 prostate cancer studies that have included more than
1,500 patients, Oncotype DX is the only genomic test that has been
validated to predict both near- and long-term outcomes and
answers the most clinically actionable question of adverse
pathology to enable more precise patient risk stratification and
better informed treatment decisions. To date more than 1,800
physicians have used the Oncotype DX prostate cancer test to plan
treatment decisions for their patients.
About Oncotype DX®
The Oncotype DX® portfolio
of breast, colon and prostate cancer tests applies advanced genomic
science to reveal the unique biology of a tumor in order to
optimize cancer treatment decisions. The Oncotype DX prostate
cancer test identifies which clinically low-risk patients are
eligible for active surveillance, as well as those who may benefit
from immediate treatment by predicting disease aggressiveness. With
half a million patients tested in more than 80 countries, the
Oncotype DX testing has redefined personalized medicine by making
genomics a critical part of cancer diagnosis and treatment. To
learn more about the Oncotype DX prostate cancer test, visit
www.OncotypeDX.com or www.myprostatecancertreatment.org.
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
early-stage cancer, one of the greatest issues in healthcare today.
The company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of massive
amounts of genomic data into clinically-actionable results for
treatment planning throughout the cancer patient's journey, from
diagnosis to treatment selection and monitoring. The company
is based in Redwood City, California, with European
headquarters in Geneva, Switzerland. For more
information, please visit, www.GenomicHealth.com and
follow the company on
Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the company's belief that
the draft LCD is an important step toward ensuring that all
prostate cancer patients covered by Medicare have access to the
test; and the benefits of the test to physicians, patients and
payors. 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: the issuance by Palmetto of an LCD and the scope of
any such LCD; the ability of test results to change treatment
decisions in the clinical setting; the risks and uncertainties
associated with the regulation of the company's tests; the results
of clinical studies; the applicability of clinical study results to
actual outcomes; the risk that the company may not obtain or
maintain sufficient levels of reimbursement, domestically or
abroad, for its existing tests and any future tests it may develop;
the risks of competition; unanticipated costs or delays in research
and development efforts; and the other risks set forth in the
company's filings with the Securities and Exchange Commission,
including the risks set forth in the company's quarterly report on
Form 10-Q for the year ended March 31, 2015. 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
DX, Recurrence Score, and DCIS Score are trademarks or registered
trademarks of Genomic Health, Inc. All other trademarks
and service marks are the property of their respective
owners.
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SOURCE Genomic Health, Inc.