Sample Collection and Processing Methods to Support Battlefield Wound Infection Diagnostics

Jan Biotech proposes to commercialize our SEPSIDX, a Sepsis Diagnostic with novel integrated sample preparation and molecular harvesting components. This entirely automated and portable sepsis diagnostic system will be suitable for far-forward military battlefield use. According to the World Health Organization, sepsis infections affected approximately 49.0 million people and resulted in 11.0 million deaths globally, and for infections treated quickly, there was a significant reduction in mortality for every hour earlier treatment was provided. The U.S. military has urgent need for a quick, cost-effective, multiplexed diagnostic for a wide variety of sepsis-causing pathogens, including drug-resistant bacteria and fungi. Sepsis Diagnostics to date have not been suitable for large panels of pathogens, do not analyze different matrices, and/or do not detect antibiotic resistance. Further, culture- and PCR-based sepsis diagnostics suffer from a low detection rate for sepsis pathogens. Our proprietary hands-free tissue homogenization and RNA extraction methods do not require any downstream diagnostic requirements, as our system includes our proprietary RNA biomarker detection technology that provide an unprecedented limit-of-detection (LOD) in a touchless platform. RNA detection has major advantages over DNA detection. The SEPSIDX assay leverage is three-prong:  (a) RNA is present at a much higher level than DNA in a cell; (b) ribosomal (r) RNA is present at a high level in actively growing cells, such as in a rapidly growing, sepsis-causing pathogen; and (3) the assay avoids detection of free DNA that could be present from noninfectious bacteria or fungi, which would be detected by PCR.