DEVELOP A COCCIDIOIDES-SPECIFIC ANTIGEN IN PATIENT SERUM OR URINE AND DEVELOP AN IMMUNOASSAY FOR COCCIDIOIDES GALACTOMANNAN

Giner’s innovation comprises of unique gene specific electrochemical detection that yields attomolar-level target DNA detection without nucleic acid amplification. The Phase I program will include: (1) Identification and selection of specific target gene sequences from Histoplasma and Coccidioides species followed by preparation of a DNA hybridization assay; (2) Electrochemical assay development and evaluation of the assay performance; and (3) Testing in clinically relevant biological samples. While the Phase I program will demonstrate a proof-of-concept of the sensor to detect specific gene sequences in blood samples, the Phase II study will expand the biological sample testing and focus on detection of phase-transition elements that play a key role in pathogenesis of dimorphic fungi.