April 21, 2015 10:57am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced the online publication of a
study entitled “ Predicting High-Grade Cancer at Ten-Core Prostate
Biopsy Using Four Kallikrein Markers Measured in Blood in the ProtecT
Study ” in the Journal
of the National Cancer Institute . 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 identifies risk for
aggressive prostate cancer prior to prostate biopsy.
The Prostate Testing for Cancer and Treatment (ProtecT) study is a
prospective randomized controlled trial conducted in the United Kingdom
for the purpose of evaluating the cost effectiveness of conventional
treatments in PSA-detected, clinically localized prostate cancer. Of the
82,428 men recruited for the trial, a total of 6129 men with elevated
PSA (≥3.0 ng/mL) who underwent prostate biopsy and provided an adequate
blood sample were tested for the four kallikreins and their 4Kscore
result was determined. The study showed that the four kallikrein panel
enhanced aggressive prostate cancer detection compared with PSA and age
alone. The area under the curve (AUC) for the 4K model was 0.820 (95% CI
= 0.802 to 0.838) while the PSA model was 0.738 (95% CI = 0.716 to
0.761) for high-grade cancer.
“The ProtecT study is the latest in a series of peer-reviewed
publications demonstrating the superior clinical value that testing with
four kallikrein markers adds to risk prediction for aggressive prostate
cancer compared to PSA alone,” said Dr. Peter Scardino, Chair,
Department of Surgery, Memorial Sloan Kettering Cancer Center. “The high
level of discrimination for differentially detecting high-grade disease
supports use of the four kallikrein panel as a reflex test prior to
having a prostate biopsy for men with an elevated PSA.”
“The 4Kscore biomarker algorithm has now been tested and published on
over 20,000 men in 11 peer-reviewed publications covering multiple US
and European cohorts,” said David Okrongly, President of OPKO
Diagnostics. “The results all demonstrated the high discrimination and
favorable decision curve benefit of the 4Kscore algorithm for predicting
the results of prostate biopsy pathology, as well as 20 year outcomes
for risk of metastatic prostate cancer.”
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 and provide valuable information to
accurately identify aggressive prostate cancer and guide clinical
decision making, 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 April 21, 2015
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