OPKO Claros1 Analyzer Selected for Development of a Rapid Lyme Disease Test Under Immuno Technologies NIH Grant

OPKO Health (Ireland)

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January 13, 2015 11:49am EST

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MIAMI & MEMPHIS, Tenn.--(BUSINESS WIRE)--

OPKO Health, Inc. (NYSE:OPK) and Immuno Technologies, Inc. today

announced that the National Institutes of Health (NIH) has awarded a $3

million grant to develop a rapid diagnostic test for Lyme disease. The

Phase II Small Business Innovation Research (SBIR) grant was issued to

Immuno Technologies working in collaboration with OPKO Diagnostics, LLC

and Columbia University in the City of New York. The goal of the grant

is to develop a rapid diagnostic test based upon novel antigens that

increase the specificity and sensitivity of the current laboratory

assays and improve discrimination between early and late stage disease

using OPKO’s Claros®1 in office analyzer. Combinations of these antigens

have already been successfully demonstrated on OPKO’s microfluidic

cassettes for the detection of Lyme disease using challenge panels from

patients.

“Prompt diagnosis and treatment is critical to prevent disease

progression, but current laboratory testing is difficult to interpret

and time-consuming,” said Maria Gomes-Solecki, President and CEO of

Immuno Technologies, Inc. “The Claros 1 system can provide rapid,

quantitative, multiplexed results, and coupled with well-selected

antigens, can greatly improve diagnosis and management of Lyme disease.”

“Our lab is pleased to participate in this collaboration to develop a

point-of-care test for such a clinically important disease,” said Samuel

Sia, Associate Professor of Biomedical Engineering at Columbia

University.

Lyme disease is a progressive disease with a wide array of largely

non-specific clinical manifestations gradually developing from early to

late stage. Moreover, Lyme disease is the most common tick-borne disease

in North America and Europe and is one of the fastest-growing infectious

diseases in the United States. According to recent estimates from the

Centers for Disease Control, about 300,000 cases of Lyme disease occur

in the United States each year.

“We look forward to development and commercialization of this

breakthrough test that will address a large and growing global health

challenge,” said David Okrongly, President of OPKO Diagnostics. “A rapid

and more accurate in-office diagnostic for Lyme disease would be a game

changer and help insure prompt and effective treatment for patients.”

About OPKO Health

OPKO is a multinational biopharmaceutical and diagnostics company that

seeks to establish industry-leading positions in large, rapidly growing

markets by leveraging its discovery, development and commercialization

expertise and novel and proprietary technologies. For more information,

visit www.opko.com .

About Immuno Technologies

Immuno Technologies, Inc. focuses on translational research for

infectious diseases. It does research and development of diagnostics and

immuno preventive (vaccines) compounds. As products evolve from the

laboratory to the next (early) stage of development its long term goal

is to design prototypes and spin off these technologies to new ventures

and seek strategic alliances. The company’s main area of interest is

Lyme disease. For more information visit www.immunotechnologies.com .

About Columbia University

Among the world’s leading research universities, Columbia University in

the City of New York continuously seeks to advance the frontiers of

scholarship and foster a campus community deeply engaged in the complex

issues of our time through teaching, research, patient care and public

service. For more information visit www.columbia.edu .

SAFE HARBOR STATEMENT

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 expected benefits of the

diagnostic test for Lyme Disease using the OPKO Claros 1 system, that

the test will increase the specificity and sensitivity of the current

laboratory assays and improve discrimination between early and late

stage disease, that the Claros 1 system will provide rapid,

quantitative, multiplexed results, and whether the test can greatly

improve diagnosis and management of Lyme disease and insure prompt and

effective treatment in patients, whether the parties will ever

successfully develop or commercialize this breakthrough test and whether

it will address a large and growing global health challenge, the market

for and expected sales of the test, 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 the

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.

David Okrongly, 305-575-4133

Source: OPKO Health, Inc.

Released January 13, 2015

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