The PSA test utilizes microfluidics system which comprises a disposable test cassette, desktop analyzer and requires a finger stick drop of blood.
The test facilitates physicians and patients by providing accurate, lab quality results within minutes.
The trial will enroll upto 400 patients and will test PSA levels over a 6-month period and is intended to demonstrate equivalence with results obtained with larger laboratory instrumentation.
The test’s clinical trial is being conducted to obtain both 510(k) clearance and potential CLIA-waiver.
OPKO Health chairman and CEO Phillip Frost said we are pleased to announce the launch of this trial as they continue with their plans to build out a larger panel of urologic tests.
