February 13, 2014 9:41am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) announced the successful completion of the
calibration confirmation phase of the 4Kscore™ test clinical validation
study currently underway at 21 urology clinics in the United States.
The OPKO 4Kscore™ test clinical validation protocol involves two parts:
a calibration confirmation phase and a validation phase. The calibration
confirmation phase evaluated the applicability of the 4Kscore™
algorithm, developed using banked samples from European studies, to the
OPKO study samples collected in the United States and shipped directly
to OPKO Lab in Nashville, TN for testing. The results confirmed the
validity of the algorithm. The study is now more than 50% complete
toward the final goal of 1,200 subjects. These results support the U.S.
launch of the 4Kscore™ test in March 2014.
“We are extremely pleased that results of the calibration phase
confirmed the 4Kscore™ algorithm is an accurate predictor of prostate
cancer, and especially aggressive disease,” said David Okrongly,
President of OPKO Diagnostics. “The reproducibility of the algorithm
speaks to the robustness of the biomarkers used in the 4Kscore™
algorithm, as well as the quality of the multiple clinical studies
published in peer-reviewed journals.”
“These results reinforce our belief that the 4Kscore™ test will be an
important addition to the urologists’ means of assessing a patient’s
risk for aggressive prostate cancer as well as an important new
diagnostic product for OPKO,” 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 generate
data to 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 enrollment of
the study and the completion date for the study, 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 be an accurate predictor of
prostate cancer, and especially aggressive disease, and whether it will
address a significant unmet medical need for better tests to identify
men at risk for aggressive prostate cancer, while at the same time
avoiding unnecessary, costly, and potentially harmful treatments, 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 that the test may be less accurate or predictive than
anticipated and those factors 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, 305-575-4100
Source: OPKO Health, Inc.
Released February 13, 2014
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