# An automated, scalable, and rapid AST system for Gonorrhea STIs

> **NIH NIH R44** · ACENXION BIOSYSTEMS, INC. · 2021 · $967,087

## Abstract

Gonorrhea is a sexually transmitted infection (STI) caused by the bacterium Neisseria gonorrhoeae (NG) that
infects the urogenital, anorectal and pharyngeal tracts in humans. In 2018, there were an estimated 1.14M
cases in the US, and 86.9M cases worldwide. Of concern is the growing incidence of antimicrobial resistance
not only due to inappropriate use of antibiotics, but also because NG interacts with and acquires genetic
material from other co-infections in the anatomical sites that it infects. This wide range of resistance
mechanisms that NG isolates can potentially harbor makes it very challenging to develop rapid molecular
methods of Antibiotic Susceptibility Testing (AST). Even among phenotypic AST methods, it has so far not
been considered feasible to perform automated broth microdilution based ASTs on NG: principally because it
is a fastidious organism in liquid culture. As a result, the primary method used to perform ASTs for NG is the
manual agar dilution method, which (because it is so labor intensive) is currently conducted in only a very
limited number of public health labs. Even these labs test only 200-300 samples a month.
Acenxion Biosystems proposes to develop the first fully automated NG phenotypic AST platform that both
satisfies the current CDC guidance for surveillance and fulfils an unmet clinical need for AST-guided “directed”
antibiotic therapy. Our instrument will provide Minimum Inhibitory Concentration (MIC) and Susceptible/
Intermediate /Resistance (S/I/R) interpretation in < 6 hours with minimal sample preparation (<5 min per
sample) at a reasonable price. The instrument will consist of stackable, cassette reader units with up to eight
microfluidic cassette capacity; software/PC Controller; and single-use consumable (50-well microfluidic
cassette pre-spotted with candidate antibiotics). Optimized broth and rapid stirring are employed for NG
growth, enabling automated broth microdilution. With prior funding from the CDC, we have demonstrated
proof-of-concept for the proposed instrument by building a partly-automated system to perform broth micro-
dilution experiments on a single 16-well cassette, and used it monitor the growth (or lack thereof) of 3 NG
strains (1 ATTC QC strain, and 2 AR isolate strains) in the presence of multiple candidate antibiotics with
100% sensitivity & specificity. We seek “Direct to Phase II” funds to expand this earlier work: build a fully
automated instrument and test it against the CDC’s challenge AR bank panel of 50 clinical isolates (which span
multiple resistance mechanisms and yield wide range of phenotypic responses). We chose this set of
organisms in lieu of patient samples from 2 - 3 locations to ensure better chances of success in the real world.
Our commercialization strategy aims to first bring efficiencies to the existing market (regional labs participating
in the Gonococcal Isolate Survey Program) and then to expand the user (customer) base to hospital labs,
clinical laboratory...

## Key facts

- **NIH application ID:** 10157322
- **Project number:** 1R44AI157675-01
- **Recipient organization:** ACENXION BIOSYSTEMS, INC.
- **Principal Investigator:** Roy R Swiger
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $967,087
- **Award type:** 1
- **Project period:** 2021-01-15 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157322

## Citation

> US National Institutes of Health, RePORTER application 10157322, An automated, scalable, and rapid AST system for Gonorrhea STIs (1R44AI157675-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10157322. Licensed CC0.

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