# Novel Biosensor for Detection of Endotoxin

> **NIH NIH R43** · MONOD BIO, INC. · 2024 · $290,066

## Abstract

Abstract. Bacterial endotoxins are components of the outer cell membranes of gram-negative organisms and is
one of the most potent human toxins. Due to the health dangers associated with endotoxin contamination, testing
is critical for pharmaceuticals, biological products, and medical devices. The majority of endotoxin testing still
relies on the Limulus Amebocyte Lysate (LAL) assays using an extract from the blood of the horseshoe crabs.
This decades-old technology threatens a limited biological resource, which is considered vulnerable by
international organizations. We seek to enable the design of new endotoxin sensors with no requirement for
horseshoe crab blood or any of its components. In addition, unlike typical analytical assays composed of multiple
biological components and often complicated assay steps, our one-step lucCage biosensor can eliminate many
complexities of existing assays as it is a "single-step, all-in-solution" assay. Our approach will be enabled through
the (i) computational design and experimental selection of functional LPS bioluminescent biosensors; (ii) in vitro
evolution of biosensors to optimize sensitivity and stability; and (iii) optimization of the LPS detection assay
conditions and formulation of a 96-well kit. With our proprietary technology, we can develop alternative de novo
protein endotoxin biosensors that provide multiple advantages over current techniques: (i) sensitivity by using
bioluminescent readouts over turbidimetric, colorimetric or fluorescent readouts, (ii) broad dynamic range in a
single test that will reduce the total number of tests required by the user to quantify endotoxin in a sample, (iii)
stability and cost, as our biosensor proteins are highly stable and easy to manufacture. Thus, successful
development of endotoxin sensing lucCage biosensors will enable the development of sustainable, inexpensive,
and robust endotoxin bioassays of high impact in the biotechnology industry.

## Key facts

- **NIH application ID:** 10822992
- **Project number:** 1R43TR004888-01
- **Recipient organization:** MONOD BIO, INC.
- **Principal Investigator:** Alfredo QUIJANO RUBIO
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $290,066
- **Award type:** 1
- **Project period:** 2024-01-01 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10822992

## Citation

> US National Institutes of Health, RePORTER application 10822992, Novel Biosensor for Detection of Endotoxin (1R43TR004888-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10822992. Licensed CC0.

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