March 25, 2014 12:18pm EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced that the American
Urological Association (AUA) has accepted “The 4Kscore TM Test
as a Predictor of High-Grade Prostate Cancer on Biopsy” as a
Late-Breaking Abstract for presentation in Plenary I on Sunday May 18,
2014 at the AUA Annual meeting in Orlando, FL.
The data accepted are from a prospective, blinded study conducted at 26
urology clinics across the United States from October 2013 to January
2014. The data confirm the accuracy of the 4Kscore TM algorithm
in a United States population of men referred for prostate biopsy. The
4Kscore TM algorithm, which is based on the values of four
different kallikrein blood tests (total PSA, free PSA, intact PSA and
hK2) plus age, DRE and prior biopsy status, was originally studied in
multiple European cohorts involving over 10,000 patients.
“These are challenging times in urology as we are seeing a decline in
men screened for prostate cancer with PSA, yet we know that mortality
from prostate cancer has steadily declined since the introduction of PSA
screening,” said Dr. Stephen M. Zappala, MD FACS of Andover Urology.
“The 4Kscore TM test offers new information on the probability
of having a Gleason Score ≥ 7 cancer prior to undergoing a prostate
biopsy. This is important, because we know that besides the potential
side effects of biopsy such as bleeding and infection, up to 80% of
prostate biopsies will either be negative for prostate cancer or will
indicate a low grade disease that may be better monitored than treated.
The 4Kscore TM test will offer both the Urologist and patient
new information for the shared decision-making discussion about whether
or not to have a prostate biopsy.”
“Acceptance as a late-breaking abstract highlights both the quality of
the clinical data for the 4Kscore TM test and the urgent need
to have a solution for more effective biomarker-based tests for managing
prostate cancer risk and the disease itself,” said David Okrongly,
President of OPKO Diagnostics. “We are looking forward to presenting the
full US clinical trial data at the AUA meeting in May.”
“The results of the US clinical study are now complete and we are
pleased to also announce that we are on track for launch of the 4Kscore
Test on March 31, 2014,” said Phillip Frost, M.D., OPKO's Chairman and
Chief Executive Officer.
About the 4Kscore™ Test
The 4Kscore™ is a convenient blood test that measures the serum levels
of four different prostate-derived kallikrein proteins: total PSA, free
PSA, intact PSA and hK2. Levels of these biomarkers are combined with a
patient's age and digital rectal exam (DRE) status using a proprietary
algorithm to calculate the probability of a finding of aggressive
prostate cancer. The 4Kscore™ test is based on over a decade of research
of the four kallikrein panel of biomarkers conducted by scientists at
Memorial Sloan Kettering Cancer Center and leading research centers in
Europe on over 10,000 patients. The information provided by the 4Kscore™
test can help facilitate the shared decision-making process between
urologist and patient in determining the advisability of a prostate
biopsy.
About Prostate Cancer
In 2013, over 238,000 new cases of prostate cancer will be identified
and 29,720 men will die from the disease, according to estimates
released by the National Cancer Institute, making it the second most
deadly cancer in U.S. men. Prostate cancer is usually first detected by
elevations in serum PSA. However, PSA level is often high for reasons
unrelated to prostate cancer and, since an elevated PSA level often
leads to biopsy, 75% of all prostate biopsies performed are either
negative or indicate a low likelihood of aggressive cancer.
ABOUT OPKO HEALTH, INC.
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 OPKO's multi-center validation study will support CLIA
validation and reimbursement, whether the 4Kscore™ will be an important
tool in the fight against prostate cancer and the prevention of
unnecessary biopsies, expectations regarding the success of the product,
whether it will provide the probability of having a Gleason Score ≥7
prostate cancer prior to undergoing a prostate biopsy, whether it will
offer new information for better shared decision-making between a
Urologist and patient about whether or not to have a prostate biopsy,
whether we will able to present the full clinical data at the AUA
meeting, whether OPKO will be able to successfully launch and
commercialize the 4Kscore™ and the expected launch date for the
4Kscore™, the market for and expected sales of 4Kscore™, whether the
test will address a significant unmet medical need for more effective
biomarker-based tests for managing prostate cancer risk and the disease
itself, 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.
Steven D. Rubin or Juan F. Rodriguez,
Source: OPKO Health, Inc.
Released March 25, 2014
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