# Rapid Drug Susceptibility Test for Tuberculosis

> **NIH NIH R41** · PULMONESCENCE DIAGNOSTICS, INC. · 2022 · $306,500

## Abstract

Project Summary
In this grant application, we propose to develop a rapid phenotypic drug susceptibility test for tuberculosis (TB)
based on our rapid sputum diagnostic test for TB. The emergence of drug resistance in tuberculosis (TB), already
the most frequent cause of infectious death in humans worldwide, constitutes a significant concern in global
health. The World Health Organization (WHO) set as a critical milestone in their End TB Strategy, a goal of a
75% reduction in tuberculosis deaths over the ten years from 2015 to 2025. However, the emergence of TB
strains with drug resistance threatens global progress toward this milestone and hinders all tuberculosis
eradication programs. Factors contributing to drug resistance include the treatment of patients with a drug that
does not affect resistant organisms, poor management of the supply and quality of drugs, and higher
transmission of TB in public places. Moreover, patients face catastrophic costs while undergoing treatment for
drug resistance and often go untreated as a result, further exacerbating the problem.
The key to the reduction and containment of these antibiotic-resistant strains is the early detection of all forms
of drug resistance in TB. To solve this problem, we are developing a rapid phenotypic drug susceptibility test
based on our novel REFtb sputum-based TB diagnostic system that can dramatically transform how the drug
susceptibility diagnosis is currently made in low-resource public settings. The broad objective of the proposed
research in this Phase 1 application is to develop the rapid phenotypic drug susceptibility test to the front-line
tuberculosis drugs.
In this Phase 1 application, we plan to carry out development of an optimized rapid phenotypic drug susceptibility
test and test antibiotic-resistant BCG spiked sputum samples. For the Phase 2, we plan to continue development
to extend these findings to drug resistant TB in preliminary clinical trials. Thus, the long-term goal of our research
is to develop a drug susceptibility test TB diagnostic that is stable in storage at ambient temperature and can be
shipped worldwide without reliance on a cold-chain. The central hypothesis of this research is that our sputum-
based REFtb diagnostic can be adapted to include drug susceptibility testing. Without the right drug susceptibility
tests available near where patients seek care, the majority of patients with MDR-TB will go undetected, second-
line treatments will not be started, and the WHO goal of TB elimination will not be met. Successful completion of
the above tasks in Phase I will begin the development of a rapid drug susceptibility test that can be used to reach
more of these patients in low-resource settings so they can be referred for additional testing and treatment, thus
significantly contributing to the goal of TB elimination.

## Key facts

- **NIH application ID:** 10379831
- **Project number:** 1R41AI167101-01
- **Recipient organization:** PULMONESCENCE DIAGNOSTICS, INC.
- **Principal Investigator:** Jeffrey D. Cirillo
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $306,500
- **Award type:** 1
- **Project period:** 2022-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10379831

## Citation

> US National Institutes of Health, RePORTER application 10379831, Rapid Drug Susceptibility Test for Tuberculosis (1R41AI167101-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10379831. Licensed CC0.

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