Portable endotoxin immunoassays on a proprietary point-of-need biosensing platform

Overview

Micromensio is developing a portable, cost-effective endotoxin detection solution by adapting ELISA-style immunoassays to its proprietary point-of-need biosensing platform. Endotoxin testing is critical across pharmaceutical manufacturing, medical device production, and clinical diagnostics, yet conventional ELISA methods demand expensive equipment and trained technicians. Micromensio's approach aims to deliver comparable or superior sensitivity and specificity in a simple, field-ready format that removes the need for laboratory infrastructure.

The core value proposition is a consumable-driven testing system: custom sensor microchips, manufactured using highly scalable microelectronics processes, perform the sensing within a disposable cartridge. The associated reader is purely electronic, robust, and very low cost, making the platform well suited for routine quality control, on-site diagnostics, and resource-limited environments.

Technical specifications

• Proprietary sensor microchips manufactured using scalable microelectronics technology, enabling high-sensitivity, multiplexed measurements within a single consumable
• Consumable-based architecture that embeds the sensing element directly in a disposable cartridge, simplifying the reader to a low-cost electronic device
• ELISA-compatible detection with demonstrated colorimetric ELISA performance matching that of a spectrophotometer using the sensor microchip
• Expected sensitivity improvement of at least two orders of magnitude over current prototype performance through optimized microchip design
• Label-free detection potential that could further simplify the product design and reduce assay complexity
• Additional assay compatibility demonstrated with ATP bioluminescence and chemiluminescent assays, indicating broad applicability beyond endotoxin testing
• Multiplexed measurement capability allowing multiple targets to be detected simultaneously from a single sample

Technology readiness level

The biosensing platform has been developed with prior research funding and is largely de-risked from a manufacturing standpoint. Sensor microchips have been validated in liquid samples, initially for a novel ion-sensing bacterial identification assay and subsequently for colorimetric ELISA and chemiluminescent assay formats, with results indicating that high performance is achievable.

A five-month proof-of-concept phase is planned to benchmark existing endotoxin ELISA assays, source endotoxin-specific antibodies, design and manufacture sensor prototypes, and characterize sensitivity using both labeled ELISA and label-free approaches. Sensitivity and specificity will be validated on real endotoxin samples, and modeling work will predict performance for an optimized custom microchip implementation. Following successful proof-of-concept, the prototype will be translated to the scalable, low-cost, multiplexed biosensor platform for further development and commercialization.