OPKO Health Announces Commencement of U.S. Clinical Trial for Point-of-Care Prostate Specific Antigen Test
News Jan 11, 2012
The PSA test on OPKO’s platform requires only a finger stick drop of blood and utilizes a novel microfluidics system consisting of a credit card size disposable test cassette and a small but sophisticated desktop analyzer to provide physicians and patients with accurate, lab quality results within minutes. OPKO has already obtained a CE mark for this PSA test in Europe and other markets outside the United States.
The clinical trial is designed for both 510(k) clearance and potential CLIA-waiver of the test. Up to 5 study sites across the United States are participating and we expect to enroll a total of approximately 400 patients. The study will test PSA levels over a 6-month period and is intended to demonstrate equivalence with results obtained with larger laboratory instrumentation. Equivalence necessary to obtain the CE mark has already been confirmed.
“I am pleased to announce the launch of this trial as we continue with our plans to build out a larger panel of urologic tests,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health, Inc.
Tweak to Technique Could Bolster Disease DetectionNews
A team of Stanford researchers has developed a technique that they hope could more precisely detect diseases or disorders such as cancer or a heart attack.READ MORE
Diagnosing Immunity to Ebola With Paper Tests & SmartphonesNews
A promising new approach to detect immunity to Ebola virus infection has been developed by researchers from i-sense in a collaboration between UCL and Imperial College London.READ MORE
New Technique Eases Production, Customization of Soft RoboticsNews
By helping rubber and plastic stick together under pressure, University of Nebraska-Lincoln chemists have simplified the production of small fluid-carrying channels that can drive movement in soft robotics and enable chemical analyses on microscopic scales.READ MORE
Comments | 0 ADD COMMENT
Precision Medicine & Biomarkers Leaders Summit: USA
May 07 - May 08, 2018