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Opko to Purchase OURLab CLIA Lab to Support US Launch of 4Kscore Prostate Cancer Dx

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Opko Health has entered a definitive agreement to acquire Prost-Data, which does business as OURLab, a Nashville, Tenn.-based CLIA laboratory.

The acquisition will provide Opko with a platform to support the US commercial launch of its 4Kscore protein biomarker prostate cancer test, the company said. Opko is planning a "near-term" US launch of the test as a laboratory-developed test.

Earlier this month, Opko started European sales of the test, marketing it through its partner International Health Technology (PM 10/5/2012).

The 4kscore diagnostic uses two protein biomarkers in the kallikrein family along with prostate-specific antigen for early detection of prostate cancer. Opko licensed the two markers from Finnish biotech firm Artic Partners in January (PM 1/30/2012).

The biomarkers were identified by researchers at Sweden's University of Malmo, Finland's University of Turku, and New York's Memorial Sloan Kettering Cancer Center, who showed that the markers, in combination with prostate specific antigen, could predict initial biopsy results in men suspected of having prostate cancer.

The researchers tested the markers in more than 8,000 men, and the markers were independently validated in the European Randomized Study of Prostate Cancer Screening.

According to Opko, use of the panel could potentially eliminate more than 50 percent of unnecessary prostate biopsies by improving on the specificity of existing PSA tests.

In a statement, Opko CEO Phillip Frost noted that "the OURlab structure will also be helpful in speeding the development and introduction of other important tests, including newly discovered antibody-based tests which utilize Opko's unique peptoid technology."

Upon completion of the deal, Jonathan Oppenheimer, founder and CEO of OURlab, will assume the role of CEO of Opko's diagnostics division.

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