# Point of care detection of fluroquinolone, bedaquiline and linezolid resistant Mycobacterium tuberculosis for rapid treatment decisions.

> **NIH AI R01** · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · 2026 · $782,450

## Abstract

ABSTRACT
 Rapid and sensitive point of care tests that can detect all forms of drug resistance are urgently needed to
enable appropriate treatment for TB. Molecular drug susceptibility tests (mDSTs) which use nucleic acid
amplification techniques to detect mutations associated with resistance to the primary tuberculosis (TB) drugs
isoniazid (INH), and rifampin (RIF), and in a few rare cases fluoroquinolones (FQs) have demonstrated the
potential of this susceptibility testing approach. However, current mDSTs are unable to detect the large numbers
of mutations which encode for resistance to the critical new anti-tubercular drug, bedaquiline (BDQ), and linezolid
(LZD). These new drugs along with FQs and another new drug Pretominid (Pa) comprise the backbone of the
most promising TB treatments of the future. Yet, without the availability of companion mDSTs, the world risks
losing these new drugs to drug resistance within a few years of deployment. We propose to use innovative new
fluidic and assay designs to enable detection of hundreds of different mutations encoding FQ, LZD, and BDQ
resistance using the standard Cepheid assay cartridge. This new test would retain all the advantages of current
Cepheid TB assays, a robust manufacturing and instrument placement base enabled by the high volume of
assays currently produced. This research program will include 4 aims. Aim 1. Develop mis-match tolerant or
“sloppy” molecular beacons (SMBs) that identify mutations associated with FQ and LZD resistance that are
optimized for ultimate use in the new three-phase highly multiplex system to be developed in this grant. Aim 2.
BDQ assay development detecting mutations in atpE and a new SMB tiling approach that queries the entire Mtb
Rv0678 gene to identify mutations causal of BDQ resistance. Aim 3 Optimize three-phase cartridge fluidics for
highly multiplex mutation detection. Aim 4. Perform an initial laboratory and clinical validation study of the final
aim 1-3 assays using stored c

## Key facts

- **NIH application ID:** 11258882
- **Project number:** 5R01AI182257-03
- **Recipient organization:** RUTGERS BIOMEDICAL AND HEALTH SCIENCES
- **Principal Investigator:** David  Alland
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** AI
- **Fiscal year:** 2026
- **Award amount:** $782,450
- **Award type:** 5
- **Project period:** 2024-02-26T00:00:00 → 2028-12-31T00:00:00

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11258882

## Citation

> US National Institutes of Health, RePORTER application 11258882, Point of care detection of fluroquinolone, bedaquiline and linezolid resistant Mycobacterium tuberculosis for rapid treatment decisions. (5R01AI182257-03). Retrieved via AI Analytics 2026-05-17 from https://api.ai-analytics.org/grant/nih/11258882. Licensed CC0.

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