NEW YORK (360Dx) – Opko Health announced today that it has received US Food and Drug Administration approval for its point-of-care Sangia Total Prostate Specific Antigen (PSA) Test using the company's Claros 1 Analyzer.
The test quantitatively measures total PSA in whole blood from a fingerstick of blood collected by a healthcare professional. It is used in conjunction with a digital rectal exam as an aid in the detection of prostate cancer in men aged 50 years or older. There are 25 million PSA tests performed in the US annually, according to Opko.
The Claros 1 platform can provide quantitative test results in 10 minutes or less in a physician's office using microfluidic technology in a credit card-sized disposable test cassette. No external reagents or blood sample preparations are required. Opko originally acquired rights to some of the technology underlying the test from Harvard University.
Opko plans to expand the number of assays on its Claros 1 platform through future submissions to the FDA, and a submission for a testosterone test is planned for later this year, according to the company.
"This approval contributes to our growing urology franchise and affords us the momentum to expand the test menu on the Claros 1 technology platform in the future," Phillip Frost, chairman and CEO of Opko Health said, in a statement. "We believe that a PSA test that provides results in the physician's office will significantly benefit the diagnostic paradigm for prostate cancer."