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Kephera Nabs $5.7M in NIAID Grants for Lyme, Chagas Tests

NEW YORK – Kephera Diagnostics said Thursday that the National Institute of Allergy and Infectious Diseases has awarded the firm two three-year grants totaling $5.7 million for development of immunoassays to aid diagnosis of Lyme disease and monitor treatment response in patients with Chagas disease.

The Framingham, Massachusetts-based startup was awarded two Phase II Small Business Innovative Research (SBIR) grants for development and testing of its immunoassays. The firm has been developing a menu of point-of-care infectious disease immunoassays with the backing of previous federal grants, mostly from the US National Institutes of Health and Centers for Disease Control and Prevention.

The firm will use a $2.8 million SBIR award for development and clinical trials of its Lyme disease ELISA, which will include collaboration with three major medical centers where Lyme patients are diagnosed and treated. The firm noted that the CDC recommends a two-step screening and confirmatory testing process because of the high rate of false positives in many current tests, and said that its assay can produce accurate results in a single step.

Kephera will also use a $2.9 million SBIR award to complete development of its blood-based immunoassay to measure immune response to Chagas disease antigens that wane quickly upon successful treatment, as well as evaluate that assay in collaboration with research and clinical partners in the US, France, and Brazil. The firm said drugs used to treat Chagas have varying efficacy in adults with chronic infections and adverse events are common, and it intends to develop an assay that can let clinicians interpret responses to treatment within one year or less. That test will be developed as an ELISA for laboratory use and a lateral flow immunoassay for use in the field.

"Each of these diseases presents significant diagnostic challenges and addressing them with unique and innovative assay solutions fits our mission at Kephera to improve the diagnosis of emerging and neglected diseases in the US and globally," Kephera CEO Andrew Levin said in a statement.