OPKO Health, Inc. announced the initiation of a multi-center clinical validation study for the company's proprietary Total PSA microfluidic assay cassette running on the Claros 1 in-office immunoassay analyzer. Over the next several months, the Total PSA clinical study will enroll approximately 1,000 patients at 15 sites across the United States. The clinical study data is expected to support the Premarket Approval (PMA) application to the FDA for the Total PSA assay and the Claros 1 analyzer, as well as pave the way for future FDA submissions of additional assays to be performed on the Claros 1 instrument.
"The Claros 1 analyzer delivers highly sensitive, quantitative immunodiagnostic test results with unprecedented convenience for the patient and the medical professional," said David Okrongly, Ph.D., president of OPKO Diagnostics. "The Total PSA assay is the first of a series of immunodiagnostics tests that we believe will make the Claros 1 platform a significant component of 21st century precision medicine."
At the heart of the Claros 1 platform is the patented microfluidics and gold nanoparticle signal amplification technology that combine to deliver accurate, high sensitivity results - from a fingerstick drop of blood - in approximately 10 minutes.
"We believe that access to rapid immunodiagnostic test results in the physician's office will be game changing for physicians in allowing them to provide enhanced quality of care for their patients," said Phillip Frost, M.D., OPKO's chairman and chief executive officer.
OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets.