November 10, 2014 8:37am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced the online publication of a
multi-institutional, prospective study of the 4Kscore Test in the
journal European
Urology . The results of the study demonstrated that the 4Kscore
provides a patient with accurate and personalized information about
their risk of having Gleason Score ≥7 prostate cancer, making it a
useful tool for selecting men who have significant disease and are most
likely to benefit from a prostate biopsy.
“The clinical validation of the 4Kscore Test has confirmed the accuracy
of the 4Kscore Test to identify men harboring a high grade prostate
cancer in a diverse United States population,” said Dr. Dipen Parekh,
Professor and Chair, Department of Urology at the University of Miami
and principal investigator for the study. “The results confirm that the
4Kscore Test addresses an important need by providing urologists and
their patient a calibrated, individual score for a patient’s risk of
aggressive prostate cancer and thus provides information useful in the
shared decision making discussion between Urologists and patients on
whether to undergo a prostate biopsy.”
“The United States clinical validation confirms prior work published on
multiple cohorts of men that were part of the European Research Study on
Prostate Cancer Screening (ERSPC) using the same biomarkers used in the
4Kscore Test,” said David Okrongly, President of OPKO Diagnostics. “We
are continuing to analyze the patient data coming from our U.S. clinical
validation study, in particular to look at associations between the
4Kscore and pathology outcomes in both biopsy and radical prostatectomy
specimens.”
About Prostate Cancer
According to the World Health Organization, prostate cancer is the
second most common cancer in men worldwide, with over 1.1 million men
diagnosed with prostate cancer in 2012 and over 300,000 men dying from
the disease. In countries like the U.S. where screening for prostate
cancer with the PSA test began 20 years ago, there has been a sharp
decline in prostate cancer mortality and sharp rise in the incidence of
prostate cancers detected. However, most of the prostate cancers that
are now detected are an indolent, non-life threatening form of the
disease. The net result has been over detection and over treatment of
indolent prostate cancers and a rise in the complications from prostate
cancer treatment such as erectile dysfunction, urinary obstruction and
incontinence.
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies risk for
aggressive prostate cancer. The 4Kscore measures the blood plasma levels
of four different prostate-derived kallikrein proteins: Total PSA, Free
PSA, Intact PSA and Human Kallikrein-2 (hK2). These biomarkers are
combined with a patient's age, Digital Rectal Exam (DRE) status (nodule
/ no nodule), and prior negative biopsy status (yes / no) using a
proprietary algorithm to calculate the risk (probability) of finding a
Gleason Score 7 or higher 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. The 4Kscore Test provides
individualized risk for the presence of aggressive prostate cancer and
adds new information to the shared decision making discussion between a
Urologist and patient.
About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and novel and proprietary technologies. For more information,
visit http://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
Test, that the 4Kscore will accurately identify risk for aggressive
prostate cancer, whether the test will bring exceptional value to
European and U.S. healthcare, whether the test will bring great benefit
to patients and the healthcare system by helping avoid the cost of
unnecessary, sometimes harmful procedures, whether the 4KscoreTest can
make a significant contribution to help target the right patients for
aggressive treatment and avoid the harms that accompany over detection
and over treatment of indolent prostate cancer, expected growth in use
of the test in the U.S. and Europe and whether OPKO will launch the test
in Latin America, whether the test will accurately predict high-grade
cancers, whether OPKO will successfully commercialize the 4Kscore, the
market for and expected sales of 4Kscore, whether the test will be an
important benefit for Urologists and their patients, 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.
OPKO Health, Inc.
David Okrongly, 305-575-4133
Source: OPKO Health, Inc.
Released November 10, 2014
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