# ConProject-001

> **NIH NIH UH3** · BECTON, DICKINSON AND COMPANY · 2020 · $525,239

## Abstract

HPV-associated cervical cancer is among the leading causes of death in women worldwide, with more 500,000
cases and 275,000 deaths annually. While repeated screening through frequent use of the Papanicolaou
(Pap) smear has drastically reduced the incidence and mortality of cervical cancer in developed nations, the
vast majority of cervical cancer-related deaths occur in low- and middle-income countries with minimal
healthcare infrastructure. Cytology-based prevention programs have proven to be extremely difficult to
implement and sustain in low-resource settings, and as a result over 85% of new cervical cancer cases
originate in developing countries. The lack of adequate infrastructure for traditional cytology-based screening
combined with the presentation of cervical cancer, where symptoms are not present until the cancer is in an
advanced stage, emphasize the clinical need for a screening test appropriate for low resource settings.
Development of a reliable Point-of-Care (POC) test with high sensitivity and specificity has the ability to reduce
the incidence and mortality of cervical cancer worldwide. We propose to develop a novel nanotechnologybased
diagnostic assay platform to detect cervical cancer progression in low-resource settings. This multiplex
assay platform, which is currently being developed for non-oncology applications by Becton Dickinson (BD), is
designed to be low-cost, easy to use, and inexpensive. We propose to adapt this platform to develop a highly
specific diagnostic test that will screen women who do not need treatment and identify women with cervical
lesions who need to be referred for colposcopy. The diagnostic test is based on Surfaced Enhanced Raman
Scattering (SERS) technology, that enables detection of multiple targets in a complex sample without the need
for washing or purification. The test and analysis is completed in less than 30 minutes, provides a “sample-inanswer-
out” workflow, making the platform ideal for a “screen and treat” test in low-resource settings.
Diagnostic development and validation will be done in close collaboration with a multidisciplinary team with
expertise in HPV and cervical cancer screening as well as clinical oncology. By combining BD’s experience in
assay development, global healthcare delivery, and regulatory approval with the clinical expertise of other team
members, the team has the expertise required to develop and validate a POC cervical cancer test for low
resource settings. In addition to BD assay development, engineering, global healthcare delivery, and
regulatory personnel, the team includes Dr. Jennifer S. Smith (UNC-Chapel Hill), Dr. Douglas Clark (UNM), Dr.
Mark Stoler (UVA Health System), Dr. Scott McClelland (UW), and clinical validation site leaders including Dr.
You-Lin Qiao (Chinese Academy of Medical Sciences), Dr. Nelly Mugo (Kenya Medical Research Institute), Dr.
Jose Fregnani (Barretos Cancer Hospital), and Dr. Adhemar Longatto-Filho (Barretos Cancer Hospital, Brazi...

## Key facts

- **NIH application ID:** 9999294
- **Project number:** 5UH3CA202663-05
- **Recipient organization:** BECTON, DICKINSON AND COMPANY
- **Principal Investigator:** JENNIFER SUSAN SMITH
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $525,239
- **Award type:** 5
- **Project period:** 2016-07-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999294

## Citation

> US National Institutes of Health, RePORTER application 9999294, ConProject-001 (5UH3CA202663-05). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9999294. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*