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OPKO Health Announces Commencement of U.S. Clinical Trial for Point-of-Care Prostate Specific Antigen Test

December 21, 2011
By

MIAMI–(BUSINESS WIRE)–
OPKO Health, Inc. (NYSE: OPK – News) today announced the commencement of a
multi-center clinical study of OPKO’s point-of-care diagnostic test for
prostate specific antigen (PSA) utilizing its proprietary diagnostic
platform. OPKO intends to submit its application to the U.S. Food and
Drug Administration for approval of the assay in 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.

About OPKO Health, Inc.

OPKO is a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical markets by leveraging its discovery, development and
commercialization expertise and novel and proprietary technologies.

This press release contains “forward-looking statements,” as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
“expects,” “plans,” “projects,” “will,” “may,” “anticipates,”
“believes,” “should,” “intends,” “estimates,” and other words of similar
meaning, including statements regarding the OPKO platform and its
expected benefits, the platform’s ability to provide lab quality results
in minutes, the design of the clinical trial, expectations regarding
enrollment and the outcome of the trial, including the demonstration of
equivalence compared to results obtained with large laboratory
instrumentation, the timing of the submission to the FDA for regulatory
approval, and our ability to build a larger panel of urologic tests, as
well as other non-historical statements about our expectations, beliefs
or intentions regarding our business, technologies and products,
financial condition, strategies or prospects. Many factors could cause
our actual activities or results to differ materially from the
activities and results anticipated in forward-looking statements. These
factors include those described in our filings with the Securities and
Exchange Commission, as well as integration issues involving Claros,
risks inherent in funding, developing and obtaining regulatory approvals
of new, commercially-viable and competitive products and treatments. In
addition, forward-looking statements may also be adversely affected by
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.

OPKO Health, Inc.
Steve Rubin, 305-575-6015

Article source: http://finance.yahoo.com/news/opko-health-announces-commencement-u-185400463.html

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