# Point of Care HPV 16/18/45 DNA Test for Cervical Cancer

> **NIH NIH R44** · CROSSLIFE TECHNOLOGIES, INC. · 2020 · $299,945

## Abstract

Point of Care HPV 16/18/45 DNA Test for Cervical Cancer.
CrossLife Technologies Inc.
Project Summary/Abstract
Human cervical cancer is the fourth most common cancer among women worldwide [1].
Despite cervical cancer has been thoroughly studied and the mortality has been
significantly reduced through efficient screening, these preventive programs are found to
be less effective in developing countries [2-3]. There are unmet needs for nucleic acids
new diagnostics that can be applied at the point-of-care to detect HPV 16/18/45 DNA for
cervical cancer.
A simple, sensitive, multiplex and robust testing kits for detecting cervical cancer
biomarker HPV 16/18/45 DNA at the point-of-care will be developed. The competitive
advantage of TARA is the utilization of a novel chemical reaction with similar detection
sensitivity and specificity compared to the Hologic Aptima HPV 16 18/45 Genotype assay
and simple readout on paper-strip more suitable for field devices without an instrument.
TARA also offers the potential for direct detection in complex sample matrices, such as
cervical sample or blood, without sample preparation. Building on the chemistry and
device innovations (TARAplex, and 1D paper network), we have made significant
progress and begun to explore integration through our established collaborations.
We aim to develop a rapid point-of-test that detects HPV at the point-of-need in < 30
minutes and is appropriate for non-laboratory settings and non-technical personnel. Our
proprietary test exploits a novel probe reaction chemistry that allows multiplexed detection
of DNA or RNA without sample purification, making it operable as a simple, hand-held
test. Patient samples to be input directly into the device without pre-processing and a
disposable cartridge carry out amplification of all targets and reports visible results that
can be read by eye. We expect a sensitivity (>90%) and specificity (>90%) to the U.S.
commercially-available the Aptima HPV 16 18/45 Genotype assay (HOLOGIC) data on
the same samples.
We will conduct a large-scale validation and obtain World Health Organization (WHO)
expedited review approval and recommendation for procurement on our product and
market it first to non-governmental organizations (NGO) such as the Doctors Without
Borders or the Gates Foundation. We will obtain USFDA 510 K clearance in Phase 3 in
order to market our product in the U.S.

## Key facts

- **NIH application ID:** 10010422
- **Project number:** 1R44CA250663-01
- **Recipient organization:** CROSSLIFE TECHNOLOGIES, INC.
- **Principal Investigator:** HyunDae Cho
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $299,945
- **Award type:** 1
- **Project period:** 2020-06-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010422

## Citation

> US National Institutes of Health, RePORTER application 10010422, Point of Care HPV 16/18/45 DNA Test for Cervical Cancer (1R44CA250663-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10010422. Licensed CC0.

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