Infectious disease diagnostics constitute a large, inadequately served medical need. Most current diagnostic approaches require obtaining a patient specimen that contains the pathogen for subsequent identification by culture, molecular amplification, or mass spectrometry. These methods are prone to false negatives due to poor sampling or false positives due to contamination from the skin and in the case of deep tissue infections, e.g., bone and joint infections, subject the patient to invasive, costly and potentially high risk sampling procedures. Other diagnostic methods measure pathogen-specific antibodies in the serum. Serum antibody levels, however, may achieve detectable levels too late after infection to be clinically useful, decline too slowly to track therapeutic effectiveness, and are often confounded by presence of antibodies produced in response to prior infection(s) and therefore do not distinguish current exposure from prior exposure to the same infectious agents.

MicroBplex’ technology overcomes these limitations of other diagnostic approaches by enabling detection of the patient’s earliest cellular immune response to infectious pathogens without the need for pathogen isolation. Our first products are directed to: (1) Lyme disease, where we provide earlier detection than current diagnostic products, an assessment of therapeutic effectiveness and distinguish new infection from prior exposure to the Lyme bacterial pathogen, and (2) Clostridium difficile infection, where we distinguish infection from colonization and identify patients that produce protective immunity and are at low risk for disease recurrence from patients that fail to produce protective immunity and would benefit from prophylaxis treatment.

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