LUNA LABS USA LLC — Department of Homeland Security SBIR Phase I: DHS221-011

Description

Emerging infectious diseases and transboundary animal pathogens are of significant consequence to biosecurity and the preservation of livestock food supplies, international trade, and the US economy. Highly contagious swine diseases, such as African swine fever and foot and mouth disease, are highly contagious and would cause an estimated $20B in losses in the event of a single US outbreak. There is an increasing demand to implement surveillance programs that facilitate the rapid detection of high consequence pathogens to allow for appropriate countermeasures to be enacted. However, diagnostic testing is typically limited to centralized laboratories and therefore has significant drawbacks, including turnaround times and costs. To address the need for rapid, simple, and fieldable surveillance technologies, Luna Labs LLC will develop the ASAP technology. ASAP will include high sensitivity molecular amplification and detection of 6 pathogens of concern to the pork industry, and be integrated into a portable, user-friendly, and automated microfluidic system. During the Phase I program, molecular amplification techniques and protocols will be refined and demonstrated to enable rapid (Obj: <60 minutes) detection of 2 of 6 target pathogens with equivalent sensitivity and specificity to gold-standard assays. Detection will be demonstrated in blood, serum, and urine (Phase I), with additional sample matrices to be validated in Phase II. Luna will also work with industry partners to complete the design and initiate prototyping of the microfluidic cassette in Phase I. During Phase II, remaining assays will be developed and integrated within injection-molded microfluidic cassettes for validation studies.