Opko Health, Inc., a multinational biopharmaceutical and diagnostics company, and Immuno Technologies, Inc. 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."


Immuno Technologies, Inc. focuses on translational research for infectious diseases. It does research and development of diagnostics and immuno preventive (vaccines) compounds.

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