OPKO Health Receives Proposed/Draft Medicare Local Coverage Determination for 4Kscore® Test
May 27 2016 - 8:30AM
Business Wire
OPKO Health, Inc. (NYSE:OPK) (“OPKO” or the “Company”)
announces that Novitas Solutions has issued a draft local coverage
determination for the 4Kscore® Test, the only blood test that
accurately identifies an individual patient's risk for high-grade,
aggressive prostate cancer. Novitas Solutions is a Medicare
Administrative Contractor (MAC) for Medicare jurisdictions L and H,
with responsibility for nearly 10 million Medicare beneficiaries in
New Jersey, Pennsylvania, Maryland, the District of Columbia and
Texas, among other geographies.
The draft local coverage determination is posted to the Medicare
Coverage Database on the Centers for Medicare & Medicaid
Services (CMS) website, and proposes to establish reimbursement
coverage for patients with PSA levels >3 ng/mL who have not yet
had a biopsy, or patients with a PSA level of >3 ng/mL who have
had at least one prior negative biopsy and are considered to be at
higher risk.
"This first MAC determination is a major milestone for the
4Kscore Test as it expands access to a potentially life-saving
tool," said Phillip Frost, M.D., OPKO's Chairman and Chief
Executive Officer. "We believe this decision by Novitas will help
accelerate further coverage decisions by other payers, and will
encourage adoption of the 4Kscore Test by physicians and patients.
More importantly, it will allow broader access to this important
test, which can assist patients and physicians in further defining
a patient’s risk of having a high-grade prostate cancer that
requires immediate or aggressive treatment.”
The draft local coverage determination follows the 4Kscore’s
inclusion as a standard-of-care in the 2015 National Comprehensive
Cancer Network Guidelines and in the 2016 European Association of
Urology Prostate Cancer Guidelines for Prostate Cancer.
About the 4Kscore Test
4Kscore is the only blood test that accurately identifies an
individual patient's risk for aggressive prostate cancer, the
lethal form of prostate cancer. The 4Kscore Test uses a proprietary
algorithm that incorporates the blood levels of four different
prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact
PSA and Human Kallikrein-2 (hK2), plus the patient's age and other
clinical information to calculate the percentage risk (probability)
of finding a Gleason Score 7 or higher grade of prostate cancer.
The four kallikrein panel of biomarkers utilized in the 4Kscore
Test is based on over a decade of research conducted by scientists
at Memorial Sloan-Kettering Cancer Center and leading European
institutions and is included as a standard-of-care in the 2015
National Comprehensive Cancer Network’s Prostate Cancer Early
Detection Guidelines. The 4Kscore Test provides individualized risk
for the presence of aggressive prostate cancer and adds new
information to the shared decision-making discussion between the
physician and the patient.
About OPKO Health, Inc.
OPKO Health, Inc. is a diversified healthcare company that seeks
to establish industry-leading positions in large, rapidly growing
markets. Our diagnostics business includes Bio-Reference
Laboratories, the nation's third-largest clinical laboratory with a
core genetic testing business and a 420-person sales force to drive
growth and leverage new products, including the 4Kscore® prostate
cancer test and the Claros®1 in-office immunoassay platform. Our
pharmaceutical business features Rayaldee™, a treatment for
secondary hyperparathyroidism (SHPT) in stage 3-4 chronic kidney
disease (CKD) patients with vitamin D insufficiency (pending FDA
approval) and VARUBI™ for chemotherapy-induced nausea and vomiting
(oral formulation launched by partner Tesaro, IV formulation in
Phase 3). Our biologics business includes hGH-CTP, a once-weekly
human growth hormone injection (in Phase 3 and partnered with
Pfizer), and a long-acting Factor VIIa drug for hemophilia
(entering Phase 2a). We also have production and distribution
assets worldwide, multiple strategic investments and an active
business development strategy. More information is available at
www.opko.com.
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as
that term is defined under the Private Securities Litigation Reform
Act of 1995 (PSLRA), which statements may be identified by words
such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "intends," "estimates," and
other words of similar meaning, including statements regarding
expected benefits of the 4Kscore, the ability to obtain broader
access to the tests for patients, our ability to accelerate
coverage decisions, the power of the 4Kscore to provide valuable
information to accurately identify aggressive prostate cancer and
guide clinical decision making, whether it will accurately predict
high-grade cancers, improve patient outcomes and reduce biopsies,
whether OPKO will successfully commercialize the 4Kscore, and the
market for and expected sales of 4Kscore, as well as other
non-historical statements about our expectations, beliefs or
intentions regarding our business, technologies and products,
financial condition, strategies or prospects. Many factors could
cause our actual activities or results to differ materially from
the activities and results anticipated in forward-looking
statements. These factors include those described in our filings
with the Securities and Exchange Commission, as well as the risks
inherent in funding, developing and obtaining regulatory approvals
of new, commercially-viable and competitive products and
treatments. In addition, forward-looking statements may also be
adversely affected by general market factors, competitive product
development, product availability, federal and state regulations
and legislation, the regulatory process for new products and
indications, manufacturing issues that may arise, patent positions
and litigation, among other factors. The forward-looking statements
contained in this press release speak only as of the date the
statements were made, and we do not undertake any obligation to
update forward-looking statements. We intend that all
forward-looking statements be subject to the safe-harbor provisions
of the PSLRA.
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version on businesswire.com: http://www.businesswire.com/news/home/20160527005108/en/
OPKO Health, Inc.Tara Mackay, 305-575-4100Investor
RelationsorMediaRooney & AssociatesTerry Rooney,
212-223-0689trooney@rooneyco.comorMarion Janic,
212-223-4017mjanic@rooneyco.comorInvestorsLHAAnne Marie Fields,
212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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