March 31, 2014 11:29am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) announced the availability of the 4Kscore TM
Test through its CLIA-accredited OPKO Lab in Nashville, TN. The
laboratory-developed test is designed to enhance the prostate biopsy
decision making process that, in the United States, leads to
approximately 1 million biopsies being performed annually, with 80% of
the results indicating no cancer or a low-grade cancer. The 4Kscore TM
Test will help to reduce unnecessary prostate biopsies by providing
information on the risk (probability) of having high-grade prostate
cancer.
The 4Kscore TM Test was developed by OPKO Lab, a division of
OPKO Health, and tested in collaboration with 26 Urology centers across
the United States from October 2013 to March 2014. Results showed that
the 4Kscore Test TM was highly accurate for predicting the
presence of high-grade cancer (Gleason score 7 or higher) prior to
prostate biopsy. The full data from the blinded, prospective U.S.
clinical validation study will be presented at the AUA Annual Meeting in
Orlando, FL on May 18 th at Plenary Session I.
“We are pleased to offer the 4Kscore Test TM at OPKO Lab to
provide Urologists with new information to inform them of the risk of a
patient’s having high-grade prostate cancer and help clarify the
decision process surrounding prostate biopsy,” said David Okrongly,
President of OPKO Diagnostics.
“We believe the 4Kscore Test TM will be an important benefit
for Urologists and their patients and may lead to lower overall
healthcare costs,” said Phillip Frost, M.D., OPKO's Chairman and Chief
Executive Officer.
About the 4Kscore™ Test
The 4Kscore™ Test 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 biopsy status (yes / no) using a proprietary algorithm to
calculate the risk (probability) of finding a Gleason Score 7 or higher
prostate cancer. The 4Kscore Test TM was developed by OPKO
Lab, a division of OPKO Health, Inc., and will be performed at OPKO
Lab’s CLIA-accredited facility in Nashville, Tennessee. The four
kallikrein panel of biomarkers utilized in the test is based on over a
decade of research conducted by scientists at Memorial Sloan Kettering
Cancer Center and leading European institutions. The information
provided by the 4Kscore Test TM can add new information to the
shared decision making discussion between a Urologist and patient in
determining the advisability of a prostate biopsy.
About Prostate Cancer
In 2014, over 233,000 new cases of prostate cancer will be identified
and 29,480 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 elevated for
reasons unrelated to prostate cancer. Although an elevated PSA level
often leads to biopsy, about 80% of all prostate biopsies performed are
either negative or indicate a low likelihood of high-grade 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 the 4Kscore™ will be an important tool in the fight
against prostate cancer and help reduce unnecessary prostate biopsies by
providing information on the risk (probability) of having high-grade
prostate cancer, whether it will accurately predict high-grade cancers,
whether the full data will be presented at AUA, whether the test will
clarify the decision making process surrounding prostate biopsy, whether
OPKO successfully launch and commercialize the 4Kscore™, the market for
and expected sales of 4Kscore™, whether the test will be an important
benefit for Urologists and their patients and will lead to lower overall
healthcare costs, 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, 305-575-4100
Source: OPKO Health, Inc.
Released March 31, 2014
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