May 15, 2015 9:06am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced the online publication of a
study entitled “ A Four-kallikrein Panel Predicts High-grade Cancer on
Biopsy: Independent Validation in a Community Cohort ” 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 identifies risk for aggressive prostate
cancer prior to prostate biopsy in a population of men referred for
prostate biopsy based on Total PSA level and a Free PSA to Total PSA
ratio.
The study evaluated the accuracy of the four kallikrein biomarkers in
the 4Kscore along with age, DRE and an algorithm (4K algorithm) to
predict risk of aggressive prostate cancer in a large community-based
setting at Skåne University Hospital, Malmö, Sweden. Like the 4Kscore US
Validation study, the Malmö study was conducted on men being referred
for prostate biopsy, but in this study, the criteria for referral
explicitly included high-risk men with an elevated PSA (greater than or
equal to 3 ng/mL) and a low percentage of Free PSA to Total PSA (less
than or equal to 20%). These inclusion criteria selected for men with a
higher risk for having aggressive prostate cancer than the cohort
studied in the 4Kscore US Validation Study. Of the 749 men recruited for
the trial, a total of 156 men (21%) were found to have aggressive
prostate cancer defined as Gleason score greater than or equal to 7. The
results demonstrated that the 4K algorithm discriminated men with
aggressive prostate cancer from men who did not have aggressive disease
with an area under the curve (AUC) of 0.78. The study also reported that
even in this high risk patient population, a substantial number of
biopsies (25%) could have been avoided. A decision curve analysis also
demonstrated a significant net benefit for the use of the 4K algorithm
in this cohort compared to performing biopsy on all men, the current
standard of care.
“The Malmö study is the 12 th peer-reviewed paper that
demonstrated the accuracy of the 4K algorithm to accurately discriminate
the presence of aggressive prostate cancer, even in a high risk
population,” said David Okrongly, President of OPKO Diagnostics. “The
results confirm that in a community-based clinical setting, the 4Kscore
algorithm improves clinical decision-making for higher risk men with
both elevated PSA and low Free PSA to Total PSA ratios, and can safely
reduce at least 25% of unnecessary prostate biopsies.”
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 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, the power of
the 4Kscore to provide valuable information to accurately identify
aggressive prostate cancer, including in higher risk populations, and
guide clinical decision making, whether it will accurately predict
high-grade cancers, whether it will reduce unnecessary biopsies by at
least 25%, 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.
OPKO Health, Inc.
David Okrongly, 305-575-4133
Source: OPKO Health, Inc.
Released May 15, 2015
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