Synthetic Biology Based Diagnostic Assay

Easily accessible rapid-result testing
Drive up Covid testing
Opportunity

Available for Licensing

TRL: 4

IP Status

US Utility Patent

Inventors

Claudia Gentry-Weeks
Christie Peebles
Kevin Morey

Reference No: 2021-009 and 2023-001
Licensing Manager

Steve Foster
Steve.Foster@colostate.edu
970-491-7100

At a Glance

​Researchers at Colorado State University have developed a novel, rapid, point-of-care diagnostic assay that requires minimal expertise and equipment to perform, utilizing synthetic biology. This test platform has application across many infectious and non-infectious agents, in human health as well as animal health, agricultural, and environmental applications.  The paper-based assay uses gene circuits to detect various targets in saliva and oral /nasal swabs.  Results are obtained in less than an hour.

 

Immediate application for the device includes COVID-19 detection.

 

Background

Current diagnostic assays have become quite advanced in many ways but rely on very traditional biological reagents, like antibodies, for biomarker detection. Synthetic biology has been identified as way to either enhance current approaches or develop completely innovative solutions to current diagnostic assays. Despite the recognition, very few groups have made the leap to include synthetic biology in low-cost assays.

Technology Overview

Synthetic biology utilizes gene circuits, which create genetic switches and cell free protein expression systems for transcription and translation of an end product. Transcription of a riboswitch in a gene circuit serves an on/off switch. Upon interaction with a trigger molecule, the riboswitch will alter its structure to allow translation of a functional protein, often a reporter gene.

This technology provides both compositions and methods of using the system to detect and quantify an analyte of interest. It does this by combining signal detection and signal amplification components into one modular test device. These components provide a cell-free synthetic gene circuit to address specific biological, biomedical, agricultural, or environmental diagnostic needs. This modular technology can be fine-tuned to meet a specific diagnostic need. 

 

An example of the diagnostic steps is illustrated in Figure 1, below.

An illustration of the diagnostic test
Figure 1
Benefits
  • Highly portable
  • No lab equipment is required to perform the test
  • Device is highly stable
  • Components of test are readily available and inexpensive
  • Antibodies are not required
  • High specificity and sensitivity
  • Anyone can perform the test
  • Can be rapidly scaled
  • Rapid results provided in 1 hour or less
  • Results can be read and recorded using a smartphone
  • Easily and quickly modified for detection of other viruses and microbes in a span of 1 week.
Applications
  • Viral infections, particularly in remote or rural areas
  • Bacterial infections
  • Immediate application for COVID-19

Last updated: October 2022