3IN1 An Innovative Product to Stabilize and Concentrate Biomolecular Species from Human Serum and Urine Samples

This proposed SBIR effort specifically aims to further optimize a highly innovative new approach termed 3IN1 for the stabilization, preservation and concentration of disease markers within serum or urine samples for later serological diagnosis. 3IN1 could potentially enable bridging the existing challenges in the need for a cold chain for transportation of clinical specimens from the point-of-collection to a diagnostic laboratory, degradation and loss of analyte content during shipping and low abundance of certain biomolecular analytes of interest all of which could lead to false negative diagnoses. Moreover, the small size, low cost and user friendly features of 3IN1 would enable seamless integration into the existing sample processing workflow currently utilized for diagnosis. Sufficient proof-of-concept for the 3IN1 approach was obtained in the Phase I. This proposed Phase II will focus on optimizing and expanding the applicability of 3IN1 to enable definitive diagnosis of the causatives of two military relevant febrile illnesses of infectious origin. Initial FDA regulatory requirements for 3IN1 will also be elucidated. The availability of 3IN1 could have a significant and positive impact at all levels of military medical care by enabling more reliable diagnosis and thereby guiding definitive treatment resulting in faster return to duty.