Opko Health Inc. (NASDAQ:OPK) 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. (Original Source)

Shares of Opko Health are currently trading at $9.45, up $0.07 or 0.80%. OPK has a 1-year high of $12.15 and a 1-year low of $8.71. The stock’s 50-day moving average is $10.86 and its 200-day moving average is $10.09.

On the ratings front, OPK has been the subject of a number of recent research reports. In a report issued on January 3, Ladenburg Thalmann analyst Kevin Degeeter maintained a Buy rating on OPK, with a price target of $19.50, which implies an upside of 105% from current levels. Separately, on the same day, Barrington Research’s Michael Petusky maintained a Buy rating on the stock and has a price target of $15.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Kevin Degeeter and Michael Petusky have a yearly average return of 9.0% and 15.3% respectively. Degeeter has a success rate of 49% and is ranked #878 out of 4350 analysts, while Petusky has a success rate of 67% and is ranked #410.

Sentiment on the street is mostly bullish on OPK stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $17.25, which implies an upside of 82% from current levels.

OPKO Health, Inc. is a multi-national pharmaceutical and diagnostics company. The company is engaged in discovering, developing, commercializing and expertise its novel and proprietary technologies with a focus to provide unmet medical needs through a range of develops solutions to diagnose, treat and prevent various conditions, including molecular diagnostics, point-of-care tests and proprietary pharmaceuticals and vaccines. It operates its business through two segments: Pharmaceutical and Diagnostics. The Pharmaceutical segment consists of pharmaceutical research and development operations in Chile, Mexico, Ireland, Israel and Spain. The Diagnostics segment consists of pathology operations and point-of-care and molecular diagnostics operations.