The US Food and Drug Administration (FDA) has granted approval for OPKO Health’s new in vitro serum or plasma test, 4Kscore Test.
The blood test is approved for men aged 45 and above who have not previously undergone a prostate biopsy or are biopsy negative.
It is also indicated for men with an age-specific abnormal total prostate-specific antigen (PSA) and/or abnormal digital rectal exam (DRE).
The 4Kscore Test uses an algorithm to provide a numerical value that determines the risk of aggressive prostate cancer before physicians decide whether to perform a prostate biopsy.
The algorithm includes four different prostate-specific biomarkers, namely Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 [hK2].
It also includes the patient’s age, prior biopsy history and DRE status.
A team at Memorial Sloan Kettering developed the algorithm based on more than 30,000 cryopreserved blood samples.
The regulatory approval for 4Kscore Test is based on data obtained from two prospective clinical trials conducted in the US.
At present, the test is available from OPKO Health’s subsidiary BioReference Laboratories, through its speciality oncology and urology division, GenPath.
BioReference Laboratories executive chairman Jon Cohen said: “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.”
Since its launch, the 4Kscore Test has been used more than 300,000 times by more than 7,700 health care providers.
The test has been included in the National Comprehensive Cancer Network Guidelines (NCCN) and European Association of Urology Prostate Cancer Guidelines since 2015 and 2016, respectively.
In September, Lucida Medical and Hampshire Hospitals NHS Foundation Trust (HHFT) started a trial of artificial intelligence (AI) software to detect prostate cancer using real-world data.