Opko Health Inc, Miami, Fla, has announced FDA approval of the Sangia total prostate-specific antigen (PSA) point-of-care test using the company’s Claros 1 analyzer.
The test quantitatively measures total PSA from a fingerstick of whole 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.
There are 25 million PSA tests performed in the United States annually. The company plans to expand the number of assays performed on the Claros 1 technology platform through future FDA submissions, including a planned submission for a testosterone test later this year.
The Claros 1 analyzer is a novel diagnostic system that can provide rapid, quantitative test results in 10 minutes, and is suitable for use in a physician’s office laboratory. The system incorporates cutting-edge microfluidic technology in a credit card-sized disposable test cassette, which is inserted into the analyzer. No blood sample preparation or external reagents are required.
“We are pleased that FDA has approved our point-of-care Sangia PSA test with the Claros 1 analyzer,” says Phillip Frost, MD, chairman and CEO of Opko Health. “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. We believe that a PSA test that provides results in the physician’s office will significantly benefit the diagnostic paradigm for prostate cancer.”
Data supporting approval of the Sangia PSA test included field-use studies at multiple clinics. The studies demonstrated that the accuracy and sensitivity of the Sangia test are comparable to results obtained using higher volume venous blood samples analyzed by large FDA-approved instruments in central reference laboratories.
For further information, visit Opko Health.
Featured image: The Claros 1 device.
