# Electrochemical Assay to Monitor Anti-TB Antibiotics

> **NIH ALLCDC R43** · GINER, INC. · 2020 · $212,083

## Abstract

PROJECT SUMMARY/ABSTRACT
Tuberculosis (TB) is one of the top ten causes of death globally and is the second most powerful single
infectious agent behind HIV/AIDS. While the incidence of TB continues to decrease every year, there has been
a significant rise in drug resistant TB (DR-TB), with 10% of the cases developing into extensively drug resistant
TB (XDR TB). The therapeutic outcome of these drug resistant TB forms are unexpectedly poor due to toxicity
of second line antibiotics and low efficacy of therapeutic regimes due to lack of blood monitoring. Despite
tremendous evidence that concentrations matter enormously and they are highly variable, therapeutic drug
monitoring in TB has been perceived as a luxury, rather than a necessity. Additionally, blood levels of
antibiotics can only be measured using sophisticated instruments in highly specialized laboratories, increasing
the cost and turnaround times and making the monitoring essentially impossible in the global clinical field.
Currently there is no rapid and cost-effective method capable of monitoring anti-TB antibiotics in blood.
A recent landmark clinical study showed that a three-drug NIX-TB regimen (Linezolid, Pretomanid and
Bedaquiline) has great potential, remarkably curing ~90% of patients with XDR-TB after only six months of
treatment. However, many patients experienced side effects due to high dose linezolid and patients often
require therapeutic drug level monitoring. This remains a major gap in TB care since this testing currently takes
one week even in high resource settings and is unavailable in most high TB incidence countries. A rapid and
simple electrochemical test to quantify the levels of anti-tuberculous antibiotics in blood meets a critical need
within TB care. Giner aims to demonstrate the feasibility of an electrochemical assay for the three antibiotics
used in NIX-TB regimen in human serum samples with low (<100 µl) sample requirements and a sample-to-
result time of <10 minutes. Quantification will be demonstrated at a broad relevant clinical range of 0.05 µg/mL
to 100 µg/mL. The Aims of the Phase I feasibility program are: 1) Development of an electrochemical assay for
each drug in NIX-TB regimen (Linezolid, Pretomanid and Bedaquiline); 2) Validation of sensitivity, specificity,
and simultaneous measurement capability; and 3) Evaluation of assay performance in human blood serum and
benchmarking against the gold standard analytical method.

## Key facts

- **NIH application ID:** 10010646
- **Project number:** 1R43GH002368-01
- **Recipient organization:** GINER, INC.
- **Principal Investigator:** Avni A Argun
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $212,083
- **Award type:** 1
- **Project period:** 2021-09-30 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010646

## Citation

> US National Institutes of Health, RePORTER application 10010646, Electrochemical Assay to Monitor Anti-TB Antibiotics (1R43GH002368-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10010646. Licensed CC0.

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