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

NIH RePORTER · NIH · N43 · $400,000 · view on reporter.nih.gov ↗

Abstract

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.

Key facts

NIH application ID
10707833
Project number
75N91022C00060-0-9999-1
Recipient
AMPLIFIDX INC
Principal Investigator
NANCY SCHOENBRUNNER
Activity code
N43
Funding institute
NIH
Fiscal year
2022
Award amount
$400,000
Award type
Project period
2022-09-16 → 2023-09-15