Project description and overview:

Examin Holdings have developed The Examin Covid Breath Test (ECBT). The ECBT is a handheld device that will detect COVID-19 on patient breath with sensitivity and specificity similar to the ‘gold standard’ PCR lab test. The device can be used in high-traffic settings such as airports, transport hubs, workplaces, or PoC. The detection platform uses a patented electrochemical biosensor to detect the virus on the patient breath. The detection process is based on quantum-mechanical tunnelling current sensors (TCS) technology, pioneered by Utah University.

The ECBT handheld device will detect COVID-19 infection and early-stage COVID-19 infection, not by detecting the body’s immune response to viral infection but by detecting the presence of the COVID-19 viral particle itself at a molecular level in the patient’s breath. In addition, the device will include sophisticated software to read capacitance changes from the sensor, which spike in response to COVID-19, a reading device and associated app, and a secure cloud database to store and communicate testing details and results to all stakeholders.

Contamination between patients is addressed by using a mouthpiece fixed on the device from a  container. On completion of each test, the mouthpiece ejects into a biohazard container for disposal. Before mounting the next mouthpiece, the handset is cleaned with an antivirus cloth at the end of each test.

This project will deliver a validated production-ready device, associated TGA/CE/FDA ready documentation and a local supply chain ready to produce to customer orders subject to TGA/CE/FDA approval.