# Next-generation phenotypic antimicrobial susceptibility test platform: rapid results and comprehensive menus

> **NIH NIH R44** · SELUX DIAGNOSTICS, INC. · 2020 · $1,000,000

## Abstract

The goal of this Phase II SBIR proposal is to develop SeLux’s rapid, comprehensive, low-
cost, phenotypic antibiotic susceptibility test (“AST”) system through FDA 510(k)
submission for fastidious bacteria and yeast. SeLux’s next-generation phenotyping (“NGP”)
platform uniquely enables rapid AST with comprehensive antimicrobial menus of >50 drugs at a
low cost from isolates and positive blood culture samples. NGP thus holds the promise to
transform infectious disease patient care by cutting 1-2 days off the standard delay to targeted
therapies. Aim 1 will optimize NGP assays for fastidious bacteria and yeast, including CDC
Urgent Threat Neisseria gonorrhoeae. Aim 2 will optimize the NGP algorithm and scale
reagents for manufacturing. Aim 3 will comprise a 510(k) equivalence study performed at three
trial and one reference site as defined by the FDA’s recent presented guidance. The proposed
work builds on SeLux’s NGP development to date, which has demonstrated performance
exceeding FDA requirements for all drugs tested to date with 13 major non-fastidious species.
SeLux has assembled a world-class R&D team and Advisory Board and has developed the
manufacturing and clinical study partnerships required for successful study completion.

## Key facts

- **NIH application ID:** 9892951
- **Project number:** 5R44AI136125-03
- **Recipient organization:** SELUX DIAGNOSTICS, INC.
- **Principal Investigator:** ERIC STERN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2018-03-14 → 2021-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9892951

## Citation

> US National Institutes of Health, RePORTER application 9892951, Next-generation phenotypic antimicrobial susceptibility test platform: rapid results and comprehensive menus (5R44AI136125-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9892951. Licensed CC0.

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