OPKO Health Inc. (NASDAQ: OPK) stock gained by 7.37% at last close whereas the OPK stock price declined by 5.39% in the after-hours trading session. OPKO is a worldwide pharmaceutical and diagnostics firm that uses its discovery, production, and marketing skills, as well as unique and exclusive technology, to achieve industry-leading positions in large, quickly developing industries.
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OPK stock’ Recent Development
FDA has authorized OPKO’s 4Kscore Test, according to OPKO Health. This test is recommended for males aged 45 and over who have never had a prostate biopsy or people who’ve had a biopsy but have an age-specific abnormal total PSA and/or an abnormal digital rectal exam (DRE). Before deciding whether or not to undergo a prostate biopsy, the 4Kscore Test offers a numerical value to identify the existence of aggressive prostate cancer.
BioReference Laboratories, an OPKO Health Company, offers the 4Kscore Test through its speciality cancer and urology branch, GenPath.
The Executive Chairman Jon R. Cohen said that since 2014, the 4Kscore Test has been offered as a Laboratory Developed Test (LDT). The FDA’s clearance adds to the evidence that it’s a valuable tool in the prostate cancer diagnostic paradigm.
The FDA granted permission based on findings from two prospective clinical trials conducted in the United States. In the United States, over 20 million PSA tests are taken each year, with 10-15% of the findings being abnormal. The 4Kscore Test is based on a proprietary algorithm that takes into account a patient’s age, past biopsy experience, and DRE condition, as well as the levels of four separate prostate specific kallikrein biomarkers. Depending on more than 30,000 cryopreserved blood samples, a team at Memorial Sloan Kettering created the algorithm, which included an examination of the association between the 4Kscore Test and the participants’ long-term prostate health result.