NEW YORK – Imec, a Belgian R&D organization focused on digital and nanotechnologies, has developed a breath-based test for SARS-CoV-2 and intends to deploy a prototype of the platform in Brussels Airport next summer. Imec has also partnered with UZ Leuven University Hospital to validate the system and is currently considering different ways to commercialize the technology.
"This is a major focus for us today," said Peter Peumans, CTO of health technologies at the Leuven-based R&D hub. "We see an immediate way in which our technology can impact society that will allow us to return to normal, because without a solution like this, a return to normal will still take another year or more," he said.
Founded in 1984, Imec, employs 4,000 people. Health is just one application area for the organization, along with energy, agriculture, and industry. Imec often works with partners to develop new chip technologies but, as a nonprofit, it relies on third parties or spinouts to bring them to market.
It also has at its disposal an array of technology platforms, including nanopore technology, biosensors, PCR-on-chip, high-throughput cytometry, microelectrode arrays, implantable devices, and others. The breathalyzer technology it has in development consists of silicon chips for collecting aerosols and droplets, coupled with a real-time quantitative PCR platform for detecting SARS-CoV-2, the virus that causes COVID-19, in samples. The turnaround time for the test is estimated at five minutes.
Imec's breathalyzer platform is completely new and not based on previously developed technology. Peumans noted that users can detect the presence of SARS-CoV-2 in droplets using a variety of methods, not just real-time qPCR. "The reason we picked real-time qPCR is because we had it on the shelf, basically," said Peumans. "But it could be next-generation sequencing based, according to the workflow, or immunoassay based," he said.
The "key innovation," is the sample collection component, which enables users to obtain aerosols from respiratory samples that can be used to test for SARS-CoV-2. Most current detection methods rely on nasopharyngeal swabs analyzed via real-time PCR, though sputum-based PCR tests, and finger-prick antibody assays are also available.
Considering SARS-CoV-2 is transmitted via respiratory droplets, breath-based tests could potentially easily discriminate contagious from noncontagious patients. Yet this has proved a challenge, Peumans said. "The respiratory sample has been underappreciated for a long time," he said. "It plays an important role, and many diseases are transmitted that way, but it is hard to get at," Peumans added.
The main obstacle has been the size of the particles involved, which are difficult to collect. Imec however was able to engineer a silicon chip with holes of a specific size and geometry to collect particles from an individual submitting a breath sample via a sample collector. A sufficient volume is considered to be 10 liters of air, the typical volume exhaled by an adult when sitting idle. "It's up to the user whether the sample is delivered in 30 seconds or a few minutes," Peumans said.
Imec is now working with UZ Leuven University Hospital to validate the platform before proceeding to field trials at Brussels Airport next summer.
The partners have received a €2 million grant from the Flemish government to support the work.
"It will be one of the first locations where we roll out," said Peumans. "That being said, we aren't there yet, and we are testing prototypes in a hospital setting to really understand the quantitative relationship between classical nasopharyngeal swab followed by PCR and compare that to our own aerosol collection plus PCR."
One point he stressed is that Imec's platform measures contagiousness. It is able to achieve this by quantifying the number of viral particles per liter of air exhaled. "The focus is really on detecting whether somebody is spreading the virus," he said. Imec's breathalyzer is therefore being envisioned as more of an economic tool than a medical tool. "It is in principle so easy and has such a fast turnaround that you can imagine doing this before you enter the workplace, before you go to a concert, before you board a plane," he said.
The road to market is uncertain at this point, but Imec is developing the breathalyzer as if it will be commercialized, including establishing quality management systems. As a nonprofit, Imec cannot commercialize the platform itself. However it has created companies in the past, such as MiDiagnostics, which relies on nanofluidic processors to diagnose and monitor various infectious diseases. Peumans is also the CTO of MiDiagnostic, but it is possible the breathalyzer will be commercialized via another route. "We are looking into which party it will be," he said.
The bigger picture
There are other companies developing breath-based tests for SARS-CoV-2. Last month, for instance, Canary Health Technologies, a US firm based in Cleveland, and Divoc Laboratories of Delhi, India, said they planned to assess a rapid breath test in a clinical trial. According to the partners, the test relies on nanosensors to detect the particles, and relies on volatile organic compounds (VOCs) in human breath as biomarkers for SARS-CoV-2.
Other firms have developed platforms for detecting VOCs as markers for the virus, such as Breathonix, a Singaporean spinout of the National University of Singapore, and Imspex Diagnostics, based in Abercynon, Wales.
VOCs are chemicals produced by cellular metabolism that change in response to infection. Therefore, individuals infected with SARS-CoV-2 emit different VOCs, and have a specific profile that can be used as a basis for diagnosis. But Imec's Peumans said that VOCs might not cut it as biomarkers for detecting the virus. Imec's test would detect the coronavirus itself.
"Our assessment is if you rely on VOCs, you will wind up with limited sensitivity and specificity," he said.
Beyond the current pandemic, Imec clearly sees a future for its newest innovation. Peumans said the platform could be used to detect influenza infection in similar settings. And the platform could be applied as a diagnostic for other indications, he noted.
"The obvious thing is to go after respiratory infectious diseases, but beyond that, there might be other biomarkers one finds in these kinds of samples, because this is a fairly intimate sample," said Peumans. "The liquid you sample comes from the surface of lung tissue which is in many respects similar to plasma," he said. "So we expect to see a lot more than just viruses eventually."