OPKO Announces Successful Confirmation of 4Kscore™ Algorithm in the United States
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.
“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”
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.