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

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