75N91022C00060

Small Business Innovation Research Program (SBIR) Phase I

PHS 2022-1 TOPIC 440 - CANCER PREVENTION and DIAGNOSIS TECHNOLOGIES FOR LOW-RESOURCE SETTINGS

A rapid point of care test for high-risk human papillomavirus HPV (hrHPV) would allow doctors to quickly identify high risk patients during routine care and perform next steps in cervical and anal cancer screening and diagnosis. The proposed system is built on a next-generation molecular diagnostic platform which provides high sensitivity and selectivity performance at a fraction of current testing costs, using a commercially available assay that can detect 15 hrHPV types with specific call-outs for high-risk HPV16 and HPV18. Specific Aim 1 involves the integration and optimization of the existing HPV assay kit into the current cartridge, and will compare analytical sensitivity to an existing HPV assay. Aim 2 compares clinical performance to an existing FDA-approved system. Aim 3 compares results from patient self-collected to clinician-collected patient swabs. Use of the proposed HPV test system at a doctor's office will provide better test access for cervical and anal cancer screening, especially in locations with limited access to laboratories such as rural or remote areas. The system is designed as a CLIA Waived test, and can also be implemented through self-collection using swabs collected by patients from the cervix or anus, further increasing patient access, flexibility and healthcare cost-effectiveness of HPV screening.

The goal of phase I is to establish the technical merit, feasibility, and commercial potential of proposed R&D efforts and determine the quality of performance of the small business awardee organization.

440

75N91022C00060

PHS-2022-1

Nancy Schoenbrunner