OPKO Announces Publication of Study Using Kallikrein Biomarkers of the 4Kscore® Test in a Large Community-Based Referral Coh...
May 15 2015 - 9:06AM
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, Malm�,
Sweden. Like the 4Kscore US Validation study, the Malm� 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 Malm� study is the 12th 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
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