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Opko Health Submits Claros 1 Prostate Cancer Test, Immunoassay System for FDA Approval

NEW YORK (360Dx) – Opko Health today announced the filing of a premarket approval application with the US Food and Drug Administration for a total prostate-specific antigen test with the firm's Claros 1 immunoassay analyzer.

The analyzer incorporates microfluidics in a credit-card sized disposable test cassette. It provides quantitative blood test results in 10 minutes and can be performed in a physician's office. No external reagents, no instrument calibration, and almost no maintenance are required. The microfluidic cassette is inserted into a desktop analyzer to produce results during the same office visit. Similar tests from clinical laboratories can take up to a week to deliver results, the company said.

The company submitted data from an 864-patient total PSA clinical study as part of its submission. Data from the multicenter clinical study showed that the Claros 1 Total PSA test improved the sensitivity of a digital rectal exam to 91 percent, detecting 2.9 times the prostate cancers compared to digital rectal exam alone.

"The Claros 1 instrument provides access to a series of in-office rapid immunodiagnostic test results,enabling physicians to determine the appropriate course of treatment for a patient during an office visit and enhancing the quality of care and patient experience," Phillip Frost, Opko's chairman and chief executive officer, said in a statement.

The company plans to leverage the distribution and marketing capabilities of its BioReference Laboratories subsidiary to make the test available to physicians, Frost said. He added that the filing would "pave the way" for future FDA submission of additional assays using the Claros 1 platform.

Opko expects to initiate clinical validation studies and to file a 510(k) application for a Claros 1 testosterone test in 2018. The company is also working to add tests for vitamin D, infectious diseases, cardiology, women's health and companion diagnostics to the Claros 1 menu.