February 20, 2015 12:37pm EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced the online publication of a
study entitled “Improving the Specificity of Screening for Lethal
Prostate Cancer Using Prostate-specific Antigen and a Panel of
Kallikrein Markers: A Nested Case-Control Study” in the journal European
Urology . The study shows that the four kallikrein panel of
biomarkers utilized in the OPKO 4Kscore® Test (Total PSA, Free PSA,
Intact PSA and hK2) accurately identify men more likely to develop
distant prostate cancer metastases, and men with a low 4Kscore were
shown to have a low risk of developing metastatic prostate cancer in a
20-year follow up period.
The study is part of the Västerbotten Intervention Project (VIP), which
was initiated in 1986 in Västerbotten County, Sweden, and is a
population-based study involving a health exam at ages 40, 50, and 60
years of age, where blood was drawn and preserved. The VIP study
included data on over 40,000 men, representing greater than 57% of the
total background population in Västerbotten County. From this cohort,
blood samples of men who developed metastatic prostate cancer and
age-matched controls of cancer free men were tested for the four
kallikreins and their 4Kscore result was determined.
“The VIP study publication is the first time biomarkers have been shown
to improve long-term prediction of distant prostate cancer metastasis,”
said Dr. Peter Scardino, Chair, Department of Surgery, Memorial Sloan
Kettering Cancer Center. “The large increase in discrimination for
lethal prostate cancer observed with the use of the four kallikrein
panel supports its use as a reflex test before prostate biopsy in men
with elevated PSA.”
“The VIP publication takes the 4Kscore test beyond predicting
histological outcome for Gleason Score greater than or equal to 7,” said
David Okrongly, President of OPKO Diagnostics. “The VIP trial
convincingly demonstrates the power of the 4Kscore to predict the 20
year risk for metastatic prostate cancer and adds valuable information
to accurately identify men at high risk for aggressive prostate cancer
and confidently avoid a biopsy in men with low 4Kscores.”
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
increase in the number of prostate cancers detected. However, most of
the prostate cancers detected are an indolent, non-life threatening form
of the disease. The net result has been a decrease in prostate cancer
mortality during the PSA era, but at a cost of over detection and over
treatment of indolent prostate cancers.
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, whether the 4Kscore will accurately identify men more likely to
develop distant prostate cancer metastases, whether the 4Kscore will improve
long-term prediction of distant prostate cancer metastasis, whether the
4Kscore test will be used as a reflex test before prostate biopsy in men
with elevated PSA, the power of the 4Kscore to predict the 20 year risk
for metastatic prostate cancer, provide valuable information to
accurately identify aggressive prostate cancer and guide clinical
decision making, help men confidently avoid a biopsy, whether it will
accurately predict high-grade cancers, 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. Peter Scardino, M.D., serves as a member of the
OPKO Urology Advisory Board.
OPKO Health, Inc.
David Okrongly, 305-575-4133
Source: OPKO Health, Inc.
Released February 20, 2015
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