FDA approves Sangia Total Prostate Specific Antigen (PSA) diagnostic Test for prostate cancer.- Opko Health

Opko Health announced that the FDA has approved the Company�s point-of-care Sangia Total Prostate Specific Antigen (PSA) Test using the Claros 1 Analyzer. The product is indicated to quantitatively measure total PSA in whole blood from a fingerstick of blood collected by a healthcare professional and is used in conjunction with a digital rectal exam as an aid in the detection of prostate cancer in men aged 50 years and older.

The Company plans to expand the number of assays on the Claros 1 technology platform through future submissions to the FDA, including a planned submission for a testosterone test later this year. Data supporting the approval of Sangia PSA test include field use studies at multiple clinics to demonstrate accuracy and sensitivity comparable to that obtained with FDA approved large analyzers used by central reference laboratories using large blood samples drawn from veins.