SBIR-STTR Award

Direct to Phase II

Lyme disease (LD), caused by the tick-borne bacteria Borrelia, is the most common vector-borne infectious disease in the US with 300,000 new cases annually. If diagnosed early and treated with appropriate antibiotics, outcomes for LD are typically excellent, but delays in treatment result in arthritis, carditis, or neuroborreliosis. The most telling manifestation of early LD is the erythema migrans (EM); however, the EM is often difficult to distinguish from an allergic reaction, and 50% of those infected never develop the rash. Displaying non-specific symptoms which mimic those of other diseases, LD can only be confirmed by laboratory tests. Current laboratory tests rely on serological methods which are ineffective at diagnosing early LD and cannot distinguish between an active and previous infection. Molecular diagnostic tests for direct detection of Borrelia from blood continue to demonstrate poor performance. The end result is that no test can detect early LD with confidence. To address this unmet need, HelixBind has developed RaPID/LD; a fully automated, ultra-sensitive test specifically designed for the direct detection of Borrelia from whole blood. RaPID/LD displays a limit of detection that is roughly two orders of magnitude more sensitive than existing molecular diagnostics. RaPID/LD will only detect active infections and incorporates a broad menu of Borrelia species. The assay has undergone preliminary analytical verification studies and has been assessed with clinical specimens. As a result of the demonstrated capabilities, RaPID/LD was selected as a Phase I winner of the US Dept of HHS's LymeX Diagnostics Prize. This proposal focuses on completing the tasks required to directly support commercialization of RaPID/LD through key verification and validation efforts required to launch the test. To ensure success in this project, we have assembled a world-class team of experts. Combined our team has deep technical expertise in assay development, microbiology, Borrelia infections, and molecular diagnostics. Our team members have been instrumental in developing multiple in-vitro diagnostic platforms and over 30 commercial in-vitro diagnostic assays, and combined with our internal regulatory expertise, has necessary experience and capabilities to ensure that all milestones will be met.

Public Health Relevance Statement:
NARRATIVE Rapid and effective diagnosis of Lyme Disease (LD) is an urgent and unmet clinical need. If diagnosed early and treated with appropriate antibiotics, outcomes for LD are typically excellent, but delays in treatment result in arthritis, carditis, or neuroborreliosis. The current standard of care for in-vitro diagnosis, relying on serological tests, lacks both specificity and sensitivity, and cannot distinguish among an active and previous infection. Molecular diagnostic methods for direct detection, while widely appreciated to be the path forward, have persistently demonstrated poor sensitivity. HelixBind has developed RaPID/LD, a best-in-class diagnostic test for the detection of early LD directly from blood with markedly improved performance attributes compared to any other commercially available test. In this CRP, HelixBind will complete the tasks necessary to launch RaPID/LD. The information provided would provide the clinician with objective information on how to identify patients with an active infection weeks before serological test results are useful. Terms: