MIAMI--(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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