Five minutes, one answer

LEUVEN, Belgium—While the efforts to develop an effective vaccine against SARS-CoV-2 and better treatments for patients who contract COVID-19 continue, work is also still underway to engineer better diagnostic testing—both for this virus and ones in the future. To that end,  imec is developing a breath test to detect SARS-CoV-2 particles in patients’ breath and has tapped the UZ Leuven University Hospital to clinically validate the test, with the goal of having a functional prototype to test at Brussels Airport this coming summer.

“Thanks to a grant of €2 million provided by the Flemish government, we are off to a flying start,” Luc Van den hove, CEO of imec, said in a press release. “After all, the speed with which we will be able to bring this test to the market will greatly depend on the proper financial support. In anticipation of other investors joining this effort, imec has decided to pre-invest the necessary resources as part of our contribution to the global fight against COVID-19.”

The offering from imec will feature both a sample collector and an analysis unit, the former of which will collect aerosol and virus particles to support the testing solution’s high-speed, real-time quantitative (RT-q)PCR functionality.

“Merging these tasks using conventional technologies would be extremely hard to do, but thanks to our innovation capability when it comes to using silicon, we have developed a chip that effectively does both,” commented Peter Peumans, chief technology officer of health technologies at imec. “Its silicon microscale PCR cavities make for thousands of impactors that allow us to capture the viral particles, while its powerful RT-qPCR functionality brings down the duration of the PCR effort from 50 to five minutes. Importantly as well, the standard silicon technology used to build this chip facilitates mass-production at a low cost.”

Current testing options such as polymerase chain reaction (PCR) tests of nasopharyngeal swabs, rapid antigen tests or serological tests of blood samples are all useful options, but they have varying utility and drawbacks; the first takes at least two days to provide results, while the antigen test is less reliable—and serological tests only detect the presence of antibodies.

“While each of these tests can provide clues about a current or past infection, none of them can determine to what extent someone can still pass the virus to others. That is why we have started developing a test that indicates, in less than five minutes, whether someone is carrying the SARS-CoV-2 virus and whether they have a high probability of being contagious,” Peumans remarked, adding that “we are designing our test to flexibly cope with the rise of other viruses and germs that spread via exhaled particles—such as influenza, RSV and tuberculosis.”

Once the testing technology is ready, UZ Leuven University Hospital team members will join imec in conducting an extensive clinical study of the accuracy and reliability of the breath test.

“We are happy to be teaming up with imec for this exciting new development,” remarked Prof. Katrien Lagrou, head of the molecular diagnostic lab of UZ Leuven. “Not only will we provide extensive clinical support to validate the test, we will also support the development using the PCR diagnostic know-how we built up at UZ Leuven for over 20 years.”

Lisheng Gao, an analyst at Lux Research, noted that “The new method, if it works, will allow faster and more comfortable testing than the incumbent PCR and antigen tests involving nose swabbing and blood draws. Imec aims to bring the new tool to clinical trials in mid-2021. Frequent, fast and on-demand massive testing is the first step to control the pandemic, making the new technology promising at first glance. However, manufacturing and logistics could be challenging and may not be accomplished before the epidemic ends. Nonetheless, these sensors may pioneer future testing methods for respiratory diseases.”

Clinical trial and manufacturing delays could indeed mean that imec’s test is not widely available before the end of the pandemic, but given that some health officials have suggested that COVID-19 could end up like the flu—a viral enemy that returns each year—it’s likely that it will still prove useful for this virus. Additionally, experts have warned that judging by the 2003 SARS outbreak and now the SARS-CoV-2 pandemic, widespread viral threats could be more common due to factors such as antibiotic resistance and land development leading to increased animal-human viral transmission. Regardless, it is certain the imec’s test, should it prove successful, will have plenty of opportunities for future use.