REDWOOD CITY, Calif.,
Aug. 17, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced that
Palmetto GBA, a Medicare Administrative Contractor (MAC) that
assesses molecular diagnostic technologies, has issued its final
local coverage determination (LCD) approving coverage of the
Oncotype DX® prostate cancer test for qualified Medicare patients
throughout the United States.
"With Medicare's coverage, each year, nearly 60,000 prostate
cancer patients and their physicians will now have the opportunity
to make more optimal treatment decisions based on the unique
biological information revealed by the Oncotype DX Genomic Prostate
Score," said Kim Popovits, chairman of the board, chief executive
officer and president of Genomic Health. "This marks an
important milestone in our work to expand the impact of our
Oncotype DX platform to meet a significant need for prostate cancer
patients and represents a large growth opportunity for Genomic
Health."
More than 220,000 men are diagnosed with prostate cancer each
year in the United States
alone. The Medicare coverage decision extends reimbursement
for Oncotype DX testing to prostate cancer patients defined as low-
and very low-risk by the National Comprehensive Cancer Network
(NCCN), who are eligible based on clinical and pathological factors
such as prostate-specific antigen (PSA) and Gleason score.
The effective date for Medicare coverage will be after the 45-day
notice period according to Palmetto GBA's process.
With 14 prostate cancer studies that have included more than
2,000 patients, Oncotype DX is the only genomic test that has been
validated to predict both near- and long-term outcomes, and
addresses the most clinically actionable question of adverse
pathology remaining in the prostate to enable more precise patient
risk stratification and better informed treatment decisions.
"More than 50 percent of newly diagnosed men have low-risk
prostate cancer that is unlikely to spread, yet a majority of
them receive immediate aggressive treatment resulting in
unnecessary surgery and radiation," said Phil Febbo, M.D., chief medical officer, Genomic
Health. "A recently published multi-center review of patient
charts showed a relative increase of 56 percent in the use of
active surveillance in patients who received their Oncotype DX GPS
compared to patients from the same practices with similar risk
factors who were not tested."
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 90 countries, 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
international 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 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 June 30, 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.