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 plasma 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, 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.
Contacts:
Steven D. Rubin or Adam Logal, 305-575-4100
