Imec and miDiagnostics set to commercialize Covid breathalyser

21 Oct 2021

A licensing agreement is intended to bring laser-based PCR test to market.

Imec, which announced in October 2020 that it was starting development of a test to identify Covid-19 virus particles in exhaled breath, has now signed a licensing agreement aimed at bringing that test to market.

A non-exclusive licensing deal for imec's technology has been signed with miDiagnostics, a spin-out from imec founded in 2015 in collaboration with Johns Hopkins University that specializes in development of point-of-care testing.

The agreement enables miDiagnostics to work towards the commercialization of a Covid-19 breathalyzer, offering an alternative to exiting Covid-19 tests based on saliva, blood or nasal swabs.

"We have succeeded in transforming a promising concept and groundbreaking technology into a functional proof-of-concept that has passed both user tests and clinical studies," said imec CEO Luc Van den hove. "This is the first time that we have gone this far in the development of our chip technology towards commercialization."

Earlier this year miDiagnostics developed a Covid-19 test platform using the company's proprietary nanofluidic chip-based technology to examine nasal swabs, designed to help PCR testing become more feasible in domestic or workplace test regimes.

The imec breathalyzer platform is designed to build upon that core chip technology and allow testing of a sample of exhaled breath to be as accurate as that using a nasal swab, by catching aerosol particles on a chip and then detecting them using a dual-laser platform.

Imec envisages a workflow in which a sample of breath collected from a subject is mixed with the PCR reagent and placed into a customized testing apparatus where it experiences thermal cycling. Viral RNA is copied into DNA, as in existing PCR Covid testing, but in this case the chemical reaction is monitored through fluorescence from the DNA.

The system uses two lasers alternately to illuminate the sample. "One is used for SARS Cov-2 detection, the other to check the validity of the test," according to imec. Any fluorescence from the sample will indicate that viral RNA was present in the original sample, and the more rapidly the fluorescence signal reaches a threshold level, the more viral material the patient exhaled.

Future pandemics, other diseases

The imec breathalyzer represents two current themes of research into Covid diagnosis: the possibility of breath analysis as a rapid test for the virus, and the use of photonics technology in Covid testing regimes.

A January 2021 study by the international medicine federation IFCC (pdf) identified more than two dozen individual research projects then underway examining the potential use of Covid breathalyzers, including the imec effort. Those involved a range of different analysis methods, with fluorescence spectroscopy one option alongside gas chromatography, mass spectrometry and specialized nanosensors.

Photonics developers are playing their part by designing sources suitable for detection of small quantities of specific molecules of interest, as part of the trend toward increasingly sensitive optical sensing.

In October 2021 a project at research institute JILA developed a laser frequency comb specifically intended for identification of disease biomarkers in breath, and indicated that one motivation behind the project was the possibility of using it for virus detection, starting with Covid-19.

Imec expects a prototype of its platform to be trialed at Brussels airport in November 2021, while the researchers go on to consider if the same technology could be adapted to detect other airborne diseases. The work may also benefit the ongoing efforts to detect biomarkers of different cancers in exhaled air, a long-standing goal of breath analysis.

"Despite the vaccination campaigns, there is still a great need for accessible and reliable rapid tests to curb new virus outbreaks or to avoid unnecessary quarantine," said Katleen Verleysen of miDiagnostics. "With our license to imec's groundbreaking technology, we aim to make our ultra-fast PCR technology compatible with exhaled air, the perfect sample for silicon-based PCR."