March 15, 2016 2:05pm EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced the decision of the
European Association of Urology (EAU) Prostate Cancer Guidelines Panel
to include the 4Kscore® Test in the 2016 EAU Guidelines for Prostate
Cancer. The panel concluded that the 4Kscore, as a blood test with
greater specificity over the PSA test, is indicated for use prior to a
first prostate biopsy or after a negative biopsy to assist patients and
physicians in further defining the probability of high-grade cancer.
“The EAU Prostate Cancer Guidelines Panel is an international,
multi-disciplinary group of specialists in prostate cancer diagnosis and
treatment,” said Dr. Alberto Briganti, Department of Urology, San
Raffaele Scientific Institute, Milan, Italy. "The decision to include
the 4Kscore in the guidelines indicates that the Panel views the 4Kscore
Test as having achieved an appropriate level of clinical evidence to
recommend its use for both assessment of asymptomatic men prior to a
first prostate biopsy and as an additional investigational test to be
done after a negative prostate biopsy."
The 4Kscore test has been studied on over 22,000 patients with results
published in 12 peer-reviewed scientific publications. The 4Kscore test
is the only blood test that accurately identifies an individual
patient’s risk for high-grade, aggressive cancer.
About the 4Kscore Test
The 4Kscore, a laboratory developed test, 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 both the 2016 NCCN Early
Detection Guidelines and the 2016 EAU Guidelines for prostate cancer.
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 Urologist and the patient.
About OPKO Health
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
(March 29, 2016 PDUFA date) 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 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,
reduce overtreatment and provide a cost effective solution for managing
prostate health, whether OPKO will successfully commercialize the
4Kscore in the U.S. and Europe, 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/20160315006596/en/
OPKO Health, Inc.
Tara Mackay, 305-575-4100
Investor Relations
or
Media
Rooney
& Associates
Terry Rooney, 212-223-0689
or
Marion
Janic, 212-223-4017
or
Investors
LHA
Anne
Marie Fields, 212-838-3777
or
Bruce
Voss, 310-691-7100
Source: OPKO Health, Inc.
Released March 15, 2016
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