OPKO Health Receives U.S. FDA Approval for the 4Kscore® Test

MIAMI, Dec. 08, 2021 (GLOBE NEWSWIRE) — 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® (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.

About the 4Kscore® Test

The 4Kscore Test is an in vitro serum or plasma test that combines four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA and human kallikrein 2) into a single numerical score that also incorporates a patient’s age, previous biopsy status and digital rectal exam results. The 4Kscore Test is indicated for use with other patient information as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal DRE. The 4Kscore Test is intended to aid in detection of aggressive prostate cancer (Gleason score ≥7/Gleason Grade Group ≥2) for whom a biopsy would be recommended by a urologist, based on current standards of care before consideration of the 4Kscore Test. A 4Kscore <5.0 is associated with decreased likelihood of a Gleason score ≥7 on biopsy.

The intended use population are:

  • Men 45-54 years old and total PSA ≥2 ng/mL and/or abnormal DRE
  • Men 55-75 years old and total PSA ≥3 ng/mL and/or abnormal DRE
  • Men ≥76 years old and total PSA ≥4 ng/mL and/or abnormal DRE

Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than once every 6 months. The test is intended for professional use only. For more information about the 4Kscore Test, please visit www.4Kscore.com.

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 www.opko.com.

Cautionary Statement Regarding Forward Looking Statements

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 product development efforts as well as other non-historical statements about our expectations, products, beliefs or intentions regarding our including statements regarding expectations about the 4Kscore Test and its benefits. 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 Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission. 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.