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08-04-2019 | FDA | News

approvalsWatch

FDA approves point-of-care PSA test

medwireNews: The US FDA has granted marketing approval for a point-of-care device for the measurement of prostate-specific antigen (PSA).

The Sangia Total PSA Test (OPKO Diagnostics, LLC, Woburn, Massachusetts, USA) uses a finger prick test to collect a blood sample and can generate a PSA result within 15 minutes. The test is approved for use in patients aged 50 years or older following results from a clinical trial of 434 men attending 10 different US centers.

The test may be used alongside a prostate biopsy for the diagnosis of prostate cancer.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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