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PROGRESS: PRevention of cervical cancer using the Genotyping scREening and Same-day Self-sampling

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA272177-01
Agency Tracking Number: R44CA272177
Amount: $1,997,669.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA21-260
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-05
Award End Date (Contract End Date): 2024-08-31
Small Business Information
740 Sierra Vista Ave, Suite E
Mountain View, CA 94043
United States
DUNS: 022196022
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (650) 544-4516
Business Contact
Phone: (650) 544-4516
Research Institution

In 2018, the World Health Organization (WHO) called for action towards achieving the global elimination of
cervical cancer. Member states ratified a strategy for achieving this goal in August 2020. The WHO plan calls
for an aggressive approach of vaccination, screening, and treatment of the human papillomavirus (HPV), the
single cause of cervical cancer. In low- and middle-income countries (LMIC), which bear 90% of the incidence
and mortality of cervical cancer globally, it is estimated that these goals will not be reached until 2120 – a
century from now. One way to shorten this timeline is through HPV self-sampling and immediate treatment for
those at the highest risk of developing invasive disease. This will only be possible through a
low-cost and effective test that is easy to use in the field, combined with triage strategies that channel women
to treatment but avoid unnecessary procedures that drain limited resources. The modified AmpFire® HPV
Genotyping test (Atila Biosystems, CA) is a new test that identifies 13 high-risk HPV types and stratifies them
by oncogenic risk into four groups. AmpFire® relies on loop-mediated isothermal amplification (LAMP) rather
than DNA extraction, thus allowing for small-batch processing in 1-2 hours at a low cost per sample. No other
HPV test has these characteristics, which allow for the development of same-day screen-and-treat strategies
that can triage women at the highest risk, reduce loss to follow-up, and decrease overtreatment. Furthermore,
the modified AmpFire® has demonstrated high sensitivity in self-collected samples. The purpose of this study is
to evaluate the performance of this in the detection of high-grade precancer (cervical intraepithelial neoplasia,
grade 2 or higher, or CIN2+). We will also pilot a same-day screen-and-treat strategy using AmpFire® and
Automated Visual Assessment (AVE), an artificial intelligence triage method based on an assessment of
cervical images captured with an ordinary smartphone. Thus, this study will accomplish the following Specific
Specific Aim 1: To estimate the test performance of self- and provider- collected modified
AmpFire® screening platform in Honduras; Specific Aim 2: To evaluate the feasibility of a single visit
approach using a self-sampled modified AmpFire® screening platform; Specific Aim 3: Evaluate the
cost-effectiveness of the same-day screen-and-treat approach using the modified AmpFire® test
followed by triage with Automated Visual Evaluation (AVE) versus the current strategy in Honduras.

* Information listed above is at the time of submission. *

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