May 19, 2014 3:04pm EDT
Download as PDF
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) announced the results of the data from its
blinded, prospective clinical study of the 4Kscore Test at 26 leading
Urology centers across the United States. The results demonstrated the
4Kscore Test is the most accurate, personalized predictor for risk of
high-grade cancer. The data were presented by Dr. Daniel W. Lin,
Professor and Chief of Urologic Oncology at the University of
Washington, as a Late-Breaking abstract at the Plenary I Session on
Sunday May 18, 2014 at the American Urological Association (AUA) annual
meeting in Orlando, FL.
The 4Kscore Test, launched by OPKO on March 31, 2014, provides a patient
with his personal risk for high-grade prostate cancer from a blood test.
The measurements used in the 4Kscore Test are four kallikrein protein
levels from the blood test (Total PSA, Free PSA, Intact PSA and hK2),
along with the patient’s age, digital rectal exam (DRE) status, and
prior biopsy status combined in an algorithm that provides a patient’s
personal risk for high-grade cancer. The panel of biomarkers used in the
4Kscore has been tested in over 10,000 men by investigators at Memorial
Sloan-Kettering Cancer Center and leading institutions participating in
the European Randomized Study of Screening for Prostate Cancer (ERSPC).
OPKO, through its OPKO Lab division, developed and validated the 4Kscore
Test. The clinical data presented at the AUA annual meeting included
1,012 men scheduled for prostate biopsy. Patients were enrolled
regardless of their PSA, age, digital rectal exam (DRE) result, or
primary versus repeat biopsy status, and represent contemporary practice
in the United States. The results demonstrated the ability of the
4Kscore Test to discriminate between men with high-grade, aggressive
prostate cancer and those men who had no findings of cancer or had
low-grade disease. The discrimination, measured by Area Under the Curve
(AUC) analysis, was 0.82 and was significantly higher than previously
developed tests. Furthermore, the 4Kscore Test demonstrated excellent
risk calibration, indicating the accuracy of the result for an
individual patient. The high value of AUC and the excellent risk
calibration make the 4Kscore result valuable information for the shared
decision-making between the Urologist and patient on whether or not to
perform a prostate biopsy, potentially reducing biopsies by 30-50%.
“The 4Kscore certainly addresses the controversies of prostate cancer
screening, primarily by reducing the number of over diagnoses and
indolent disease,” said Dr. Daniel Lin, Professor and Chief of Urologic
Oncology at the University of Washington. “It will also address the
concerns of policy makers and others who question prostate cancer
screening in general.”
“The 4Kscore Test is emblematic of the type of innovation OPKO Health is
delivering to the healthcare market,” said Phillip Frost, M.D., OPKO's
Chairman and Chief Executive Officer. “We are committed to continually
delivering products that will improve the lives of patients and benefit
society as a whole.”
About the 4Kscore Test
The 4Kscore test is a convenient blood test that measures the blood
Total PSA, Free PSA, Intact PSA and hK2. Levels of these biomarkers are
combined with a patient's age, DRE status (nodule / no nodule), and
prior biopsy status (yes / no) using a proprietary algorithm to
calculate the probability of a finding of prostate cancer with Gleason
Score ≥7 upon biopsy. 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 high value of
4Kscore test AUC and the excellent risk calibration make the 4Kscore
result valuable information for the shared decision-making between the
Urologist and patient on whether or not to perform a prostate biopsy,
potentially reducing biopsies by 30-50%.
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 and, since an elevated PSA level
often leads to biopsy, about 80% 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 the 4Kscore will be the most accurate, personalized
predictor for risk of high-grade cancer, whether the test will
accurately discriminate between men with high-grade aggressive cancer
and those with no cancer or low-grade disease, whether OPKO will be able
to successfully commercialize the 4Kscore, the market for and expected
sales of 4Kscore, whether the test 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, whether the test will address the
controversy of prostate cancer screening by reducing the number of over
diagnoses of indolent disease, and whether it will reduce
concerns in policy makers who question prostate cancer screening in
general, 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 Adam Logal, 305-575-4100
Source: OPKO Health
Released May 19, 2014
email Email Alerts
location_city Company Profile
contact_page Contacts
rss_feed RSS News Feed
account_tree Sitemap
Apply on OPKO Health (Ireland)’s careers page