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

> **NIH NIH N43** · AMPLIFIDX INC · 2022 · $400,000

## 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 organization:** AMPLIFIDX INC
- **Principal Investigator:** NANCY SCHOENBRUNNER
- **Activity code:** N43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $400,000
- **Award type:** —
- **Project period:** 2022-09-16 → 2023-09-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10707833

## Citation

> US National Institutes of Health, RePORTER application 10707833, PHS 2022-1 TOPIC 440 - CANCER PREVENTION & DIAGNOSIS TECHNOLOGIES FOR LOW-RESOURCE SETTINGS (75N91022C00060-0-9999-1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10707833. Licensed CC0.

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