# SBIR PA22-176 - Rapid Point-of-Care Detection of Human Papillomavirus

> **NIH ALLCDC R43** · ELECTRONUCLEICS, INC. · 2023 · $275,760

## Abstract

Project Summary
The goal of this project is to demonstrate feasibility of a rapid (≤5 mins), sensitive system for the point-of-care
(POC) detection of human papillomavirus (HPV) in human vaginal samples that integrates our patented detector
of pathogens based on identification of species-specific, nucleic acid (NA) sequences. The detector relies on a
patented electromechanical signal transduction mechanism that enables the low-cost, optics-free and
amplification-free (e.g., no PCR) detection of DNA/RNA at ultralow concentration (~10-19 M). A compelling need
persists for rapid (minutes), cost effective, POC NA detection devices for infectious disease diagnostics so as to
facilitate prompt, well-informed therapies and counseling and to avoid potentially harmful actions including the
inappropriate prescription of antibiotics. In earlier work, we demonstrated the detection of Neisseria gonorrhoeae
(NG) with sensitivity of ~98% and specificity of ~100%. We currently are gathering similar data for detection of
Chlamydia trachomatis (CT). Since HPV is the most common STI and the cause of slowly developing cervical
cancers, it is a logical target for us to address in order to facilitate life-saving precancer screening. A key feature
of our patented detector is the use of peptide nucleic acid (PNA) capture probes, which are uncharged polyamide
analogs to NAs that share the same base chemistry. Since bead-PNA conjugates are designed to be charge
neutral, they do not exhibit electrophoretic movement in the presence of a DC electric field. However, the
substantial negative charge acquired upon capture of a target NA sequence makes the hybridized conjugate
mobile. Electrophoresis of the bead-PNA conjugate with hybridized target NA to the mouth of a smaller diameter
glass pore causes a significant increase in pore resistance, thereby resulting in a strong, sustained drop in
measured ionic current. Nonspecifically bound NA is removed from the bead conjugate in the strong electric
field at the pore mouth resulting in no sustained signal. Further, the opposing electroosmotic flow through the
glass pore sweeps PNA-bead conjugates without hybridized target away from the pore mouth. In such a way,
this simple conductometric device gives a highly selective (no observed false positives), binary response
signaling the presence or absence of the target NA (and associated pathogen). This project focuses on three
Aims: 1) Detection of highest risk HPV mRNA in media at ≤10-19 M (~60 copies/mL) and of HPV-infected human
cells at ~5-10 cell/mL; 2) Development and testing of an integrated, lateral flow assay (LFA)-based prototype
device for rapid (≤5 mins) detection of HPV-infected human cells at ~5-10 cells/mL; and 3) Demonstration of
highest risk HPV detection in remnant clinical samples in 95% concordance with an approved commercial nucleic
acid amplification test (NAAT). Successful achievement of these Aims will result in a device concept ready for
manufacturable prototyp...

## Key facts

- **NIH application ID:** 10761537
- **Project number:** 1R43IP001231-01
- **Recipient organization:** ELECTRONUCLEICS, INC.
- **Principal Investigator:** Zhenrong Zheng
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2023
- **Award amount:** $275,760
- **Award type:** 1
- **Project period:** 2023-09-30 → 2024-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10761537

## Citation

> US National Institutes of Health, RePORTER application 10761537, SBIR PA22-176 - Rapid Point-of-Care Detection of Human Papillomavirus (1R43IP001231-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10761537. Licensed CC0.

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