NEW YORK – Opko Health announced on Wednesday that its 4KScore prostate cancer test has received approval from the US Food and Drug Administration.
The test is approved for men 45 and older who have not had a prior prostate biopsy, or who are biopsy negative, and have an age-specific abnormal total prostate specific antigen and/or abnormal digital rectal exam. The assay uses an algorithm to provide a numerical value to determine the presence of aggressive prostate cancer to help clinicians decide whether to perform a prostate biopsy.
The algorithm draws on the values of a patient's four different prostate specific kallikrein biomarkers, as well as the patient's age, prior biopsy history, and digital rectal exam status, to return a result, Opko said in a statement.
4KScore is available through Opko subsidiary BioReference Laboratories' specialty oncology and urology division GenPath. It has been available in the US as a laboratory-developed test since 2014, Opko said, adding more than 300,000 tests have been performed.
"The FDA approval provides further validation of its value as an important tool in the diagnostic paradigm for prostate cancer," Jon Cohen, BioReference's executive chairman, said in a statement.
The approval is based on data from two US prospective clinical studies, Opko said.