Benzinga | Dec 8, 2021 08:03AM EST

OPKO Health Reports Received US FDA Approval For 4Kscore Test

OPKO Health, Inc. (NASDAQ:OPK) today announced that the U.S. Food and Drug Administration (FDA) has approved OPKO's 4Kscore Test. This test is approved for use in men age 45 and older who have not had a prior prostate biopsy or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam (DRE). The 4Kscore Test provides a numerical value to assess the presence of aggressive prostate cancer before a decision is made to perform a prostate biopsy.

The 4Kscore Test is currently available at BioReference Laboratories, an OPKO Health Company, through its specialty oncology and urology division, GenPath.

"The 4Kscore Test has been available as a Laboratory Developed Test (LDT) since 2014. The FDA approval provides further validation of its value as an important tool in the diagnostic paradigm for prostate cancer," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories, Inc.

The FDA approval is based on data from two prospective clinical studies carried out in the United States. Annually, about 20 million total PSA tests are performed in the United States and 10-15% of the results are found to be abnormal. The 4Kscore Test is calculated using a proprietary algorithm that includes values of a subject's four different prostate specific kallikrein biomarkers, age, prior biopsy history and DRE status. The algorithm was developed by a team at Memorial Sloan Kettering, based on more than 30,000 cryopreserved blood samples, including assessment of the relationship of the 4Kscore Test to the subjects' long-term prostate health outcome.

The 4Kscore Test has been used by more than 7,700 health care providers including approximately 4,200 urologists. Over 300,000 tests have been performed since its launch as an LDT in 2014. The test has been included in the National Comprehensive Cancer Network Guidelines(r) (NCCN) since 2015 and European Association of Urology Prostate Cancer Guidelines since 2016. OPKO has offered the 4Kscore Test in the U.S., Europe and elsewhere.