June 07, 2016 4:05pm EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK) today announced that senior
management will discuss recent draft local coverage determinations by
certain Medicare Administrative Contractors for OPKO’s 4Kscore® test at
the Jefferies Healthcare Conference in New York City on Thursday, June
9, 2016 at 11:30 AM (EDT). OPKO previously announced that Novitas
Solutions issued a positive draft local coverage determination proposing
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. The draft coverage determination was subsequently
retired by Novitas due to a potential conflict with another Medicare
Administrative Contractor. Palmetto GBA had issued a draft non-coverage
determination on May 27 th for the 4Kscore test.
The 4Kscore test, extensively studied in over 22,000 patients with
results presented in 12 peer reviewed scientific publications, improves
health outcomes by avoiding unnecessary biopsies while accurately
identifying men at high risk for a serious prostate cancer. The 4Kscore
test has been adopted into NCCN guidelines and impacts physician and
patient decisions while reducing healthcare costs. OPKO had not
submitted complete dossiers to either Novitas or Palmetto in advance of
their draft determinations and is providing both organizations with a
complete data package including the background, extensive clinical
validation and physician experience in support of the 4Kscore. OPKO
believes there is more than enough scientific and clinical data to
justify a positive local coverage decision by Medicare Administrative
Contractors and intends to work closely with these organizations to
demonstrate the value of the 4Kscore test to improve individual patient
care as well as the efficiency of healthcare systems.
The Jefferies presentation will be webcast on the OPKO Investor
Relations page of the corporate website at www.opko.com .
To access the live webcast please log on to the OPKO site approximately
fifteen minutes before the presentation to register and download any
necessary audio software. The audio presentation will be available at
this link for a limited time after the live presentation.
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 in stage 3-4
chronic kidney disease patients with vitamin D insufficiency 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), a long-acting Factor VIIa drug for
hemophilia (in Phase 2a) and a long acting oxyntomodulin for diabetes
and obesity (in Phase 1). 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, our ability to
obtain positive coverage for the 4Kscore from Novitas, as well as other
Medicare Administrative Contractors and payers, whether OPKO has enough
scientific and clinical data to justify a positive local coverage
decision by any Medicare Administrative Contractor, whether the 4Kscore
helps avoid unnecessary biopsies while accurately identifying men at
high risk for a serious prostate cancer, the ability to 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160607006671/en/
OPKO Health, Inc.
Tara
Mackay, +1 305-575-4100
or
Rooney
& Associates
Terry Rooney, +1 212-223-0689
Marion
Janic, +1 212-223-4017
or
LHA
Anne
Marie Fields, +1 212-838-3777
Bruce
Voss, +1 310-691-7100
Source: OPKO Health, Inc.
Released June 7, 2016
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