Low-volume, point-of-need diagnostic assays via cell-free synthetic biology

Overview

This innovative solution uses cell-free synthetic biology to develop low-volume, visually interpretable assays for diagnostic applications. Using processed bacterial lysates, we leverage cellular functions like transcription and translation for in vitro sensing of molecular targets and transduction of that signal into measurable (and usually visually interpretable) outputs. This yields a user-friendly, point-of-need test that can provide colorimetric readouts for quick, semi-quantitative assessments or fluorescent readouts for more accurate, fully-quantitative measurements using simple devices like a cell phone.

Technical specifications

• Cell-free system: Uses processed bacterial lysate to perform transcription and translation.
• Modular sensing capabilities: We have multiple platform technologies that allow for easy re-engineering of an existing sensor towards new targets, including modular protein detection and modular nucleic acid detection. We also have numerous bespoke applications for small molecule sensing.
• Clinically relevant sensitivity: Assays use existing biological machinery plus signal amplification as needed to detect clinically relevant analyte concentrations.
• Assay format: Assays function in sample volumes as low as 8 uL and complex sample matrices including blood, suitable for minimally invasive fingerstick samples.
• Readout options: Colorimetric or fluorescent readouts for varying levels of precision.
• Storage and transport: Assays can be lyophilized for ease of storage and transport, eliminating the need for a cold chain.
• Applications to date: Sensors for zinc, homocysteine, vitamins B12 and C, and multiple different protein targets.

Technology readiness level

This technology is at TRL 4, as it has been validated in a laboratory environment. Future work includes collaborating with sponsors to refine assay formats and develop new sensors, adapting the technology for practical deployment.