Want to bring back major sports events and concerts? The answer may lie in a mouthwash test for COVID


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The test arrived in the mail in early November. I took it on a Wednesday, then mailed off my sample to Vienna for processing. On Friday, I received an email with a link to my results: negative.

I didn’t have the symptoms anyway, apart from fatigue—a common symptom of having an early rising toddler—but given the fact that many carriers remain asymptomatic, it was good to confirm I didn’t have COVID-19.

The test in question came from an Austrian startup called testFRWD, one of the many companies trying to solve the challenge of returning to a safe semblance of normality, through easier and more widespread coronavirus testing.

The company was cofounded by Hennes Weiss, an Austrian music promoter, who is desperate to revive the live-music scene that is currently locked down across much of Europe.

The solution he and his partners—entrepreneur Veit-Ander Aichbichler and virologist Christoph Steininger—are offering is, well, a solution. Specifically, a saline solution that comes as part of a single-use home-testing mouthwash kit from Lead Horizon, Steininger’s diagnostics firm.

Now spit

It’s basically a more comfortable alternative to the familiar method of gathering samples for polymerase chain reaction (PCR) coronavirus tests—though it does constitute something of a balancing act, given that you need to do the whole thing in front of a webcam or your phone’s camera.

Rather than sticking a swab up your nose or down your throat, you swish around a small amount of saline solution in your mouth for at least a minute, release it through a paper straw into a tube that already contains some liquid, hold up the tube so the unique number is visible to the camera, then seal it with one of the stickers in the pack. And into the mail it goes, for processing at one of the many labs that have been processing COVID-19 PCR tests for much of the year.

Lead Horizon COVID-19 test
David Meyer

If the test comes back positive, the result is automatically entered into the national epidemic notification system (Austria’s system in this case—though once testFRWD expands into Germany, where I live, it would go into the German system).

If it comes back negative, you can download a certificate saying as much, for 1.90 euros ($2.22). If the test was ordered by an employer, entering a code will send the result directly to them. And that is really the point of the exercise—to prove you tested negative very recently, so you can get into a concert or a soccer match, board a flight, or go to school or a workplace.

“We thought about how to make an event possible—only if you can control the risk of infection at the event,” says Aichbichler. “But how can we test a lot of people at the same time? The first bottleneck is that we couldn’t easily collect the samples for 10,000 people in a day. If you have to have medically trained staff to collect the samples, it’s impossible.

“We know mouthwashing has at least the same accuracy as the nasal swab. If we can decentralize testing—get the sample collection away from a testing area—everyone can do it at home.”

TestFRWD’s mouthwash kit has been on sale for a couple of months in Austria and is already being used by police forces and schools. The startup is beginning a rollout in Spain and Portugal and is in negotiations with German labs and the large German drugstore chain DM about expansion there too.

At the moment, the test costs 190 euros ($225) in Austria, but Aichbichler expects that to fall as lab costs are negotiated down. “We think we’ll be able to offer the test in Germany for under 100 euros,” he says. Ultimately, the plan is for people to get a Lead Horizon test when they buy a ticket to a concert or game, with the cost being split among the promoter, the government, and the person taking the test.

But how accurate is this method of testing?

Beating PCR

In the case of Lead Horizon, it’s about as accurate as a swab-based PCR test—that is to say, extremely accurate, as long as the sample is fresh enough. All that differs is the sample-collection method.

PCR tests are the current gold standard when it comes to judging coronavirus infections, but some researchers and companies think they can do better. And again, noninvasive mouthwashes come into play.

Andrea Sinz, a pharmacy professor at the Martin-Luther University in Halle, Germany, points out that the PCR method—essentially, to amplify the genetic material in the sample, in order to spot the SARS-CoV-2 virus—can sometimes result in false-positives.

Sinz and her team have developed a different technique that involves a gargle solution and a technology known as mass spectrometry, which she says allows a lab to identify the coronavirus’s proteins with ultimate certainty.

“There is no mistake possible. We can even distinguish different strains,” she says.

The Halle team have been planning for months to develop the technique along with a startup in Frankfurt and have just received the go-ahead for government funding. They reckon they can get the testing time down from five minutes—which is how long it takes with their initial processing method—to mere seconds with the technique they are now developing.

“We need more testing capabilities with regards to [reestablishing] normal life—schools, concerts, sports games,” says Sinz. “That’s the way to live with it. We cannot shut down everything because of the virus. It will just not go away.”

One-second screening

Another outfit taking the spectrometry tack is Virusight, a joint venture between Newsight Imaging and the Sheba Medical Center near Tel Aviv.

This time, the journey began in the semiconductor world—cofounders Eyal Yatskan (CTO) and Eli Assoolin (CEO)—pictured below—previously worked together at TransChip, the company that developed the first CMOS camera sensor for phones (Samsung bought it in 2007).

Newsight co-founders Eli Assoolin & Eyal Yatskan, with Professor Eli Schwartz from Sheba Medical Center.
Newsight cofounders Eli Assoolin (left) and Eyal Yatskan (right), with professor Eli Schwartz from Sheba Medical Center.
Virusight

A year ago, they developed a spectrometer on a chip, which they piloted with Israel’s national water company as a tool for water-monitoring systems; this type of spectrometry identifies substances by measuring light wavelengths.

“Once corona happened, we took everything we knew and tried to make it work for the diagnosis of corona,” says Assoolin. The result is SpectraLIT, a compact spectrometer that Virusight says could be used for screening liquid samples—either from mouthwashes or from swabs—in just one second.

SpectraLIT is currently going through certification processes in the U.S. and Europe, and there are 26 pilots ongoing in hospitals around the world. ICTS, the European airport security giant, is also trialing it, using the mouthwash technique.

“We are not trying to develop something instead of PCR in diagnostics,” says Assoolin. “We are planning a screening device. PCR is not a screening device. It was not meant to be a screening device—it became a screening device because other systems like [rapid antigen testing] do not work.” (The U.S. Food and Drug Administration warned about false-positives from rapid tests earlier this month; some antigen tests reportedly have a sensitivity as low as 50%.)

So far, the screening device has been able to achieve high correlation with PCR tests, which suggests they are very accurate. In some cases it has only achieved correlation of around 85%, but Assoolin insists that the system will improve, thanks to the self-teaching of Virusight’s A.I. system.

“We will charge per check—a few dollars, maybe $1 in very big quantity,” says Assoolin. “The device itself is not going to cost a lot. We’re developing a robot to do mass screening in the interest of sports—we’ve been in touch with some leagues in the U.S.…You can also place a device like this at the entrance of a concert, and check the audience quite quickly.

“I really hope [the virus] is not going to stay with us for a long time,” he added. “But for the time being, I think we can play a role in bringing life back to normal.”

More health care and Big Pharma coverage from Fortune:

  • Creating a COVID vaccine is only half the battle
  • Biden’s COVID-19 task force is 38% female and 69% underrepresented minority
  • Infectious disease experts are very excited about the Pfizer and BioNTech vaccine
  • We don’t know enough about COVID antibodies to count on them
  • U.K. to use A.I. to spot dangerous side effects in the millions of COVID-19 vaccinations it will deliver

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