# POINT of CARE: PrOviding an Innovative New Triage and Treatment strategy for Cervical cAncer scReening Efficiency

> **NIH NIH R01** · BASIC HEALTH INTERNATIONAL, INC. · 2024 · $481,280

## Abstract

PROJECT SUMMARY
Although preventable, cervical cancer is a leading cause of mortality in low- and middle-income countries
(LMIC). Infection with high-risk human papillomavirus (HPV) can lead to cervical precancer (cervical
intraepithelial neoplasia grade 2 or higher, or CIN2+). The World Health Organization (WHO) endorses both
ablation and excision treatment of CIN2+. Excision requires specialized equipment and high-level providers
and is generally not used in LMIC. Thermal ablation (TA) is commonly used to treat CIN2+ in LMIC.
Conventional TA is performed with a non-portable desktop device that requires electricity. The WHO endorsed
TA in 2019 based largely on data from the desktop device, which uses an endocervical probe for every
treatment. Cure rates with the desktop device were 97% after 18 years of follow-up, likely due to using an
endocervical probe being used. Endocervical probes can treat the entire squamocolumnar junction (SCJ),
where cervical cancer arises, versus a flat probe alone. Handheld, inexpensive, portable, battery-operated TA
devices were recently created for use in LMIC. None of the current handheld devices have an endocervical
probe, and cure rates in LMIC are significantly lower at 83%. Liger Medical (Lehi, UT) manufactures a
prototype that is a combination handheld TA device and digital colposcope, the IRISTM, for use in LMIC. The
IRISTM will be modified to include an endocervical probe. In addition, the IRISTM will integrate a machine
learning (ML) algorithm, automated visual evaluation (AVE). When AVE is combined with HPV genotyping,
preliminary data has shown an area under the Receiver Operating Characteristics (ROC) curve (AUC) of 0.89
with a limited total extreme misclassification rate of 3.4% (CIN2+ as normal or normal as CIN2+).The purpose
of this proposal is to modify the current IRISTM device and clinically validate the changes through the following
aims: Specific Aim 1: To modify the IRISTM prototype device for optimal use in LMIC by a) modifying the existing
probes and b) adapting it to have a machine learning component, automated visual evaluation (AVE); Specific
Aim 2: To clinically validate the IRISTM endocervical probes by estimating the cure rates of CIN2+ one year
after treatment; and Specific Aim 3: To perform a retrospective validation of the AVE algorithm on IRISTM
images utilizing HPV genotyping and histopathologic disease status.
The IRISTM device has the potential to be a global game changer in the field of cervical cancer
prevention. Successful modification of the IRISTM will result in more effective precancer treatment, less
over-treatment, and increased efficiency of screen-and-treat approaches. This project will bring
effective point-of-care triage and treatment to cervical cancer elimination programs in LMIC.

## Key facts

- **NIH application ID:** 10980567
- **Project number:** 1R01CA285369-01A1
- **Recipient organization:** BASIC HEALTH INTERNATIONAL, INC.
- **Principal Investigator:** Karla Alfaro
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $481,280
- **Award type:** 1
- **Project period:** 2024-09-18 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10980567

## Citation

> US National Institutes of Health, RePORTER application 10980567, POINT of CARE: PrOviding an Innovative New Triage and Treatment strategy for Cervical cAncer scReening Efficiency (1R01CA285369-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10980567. Licensed CC0.

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