What if you went on a date and took a small device with you? At the start of the evening, you’d run a test on the device. Half an hour later, you could show the date the result: you’re free of sexually transmitted diseases. Oh, and from Covid-19, too.
This scenario is just one of the potential uses for the miniaturized polymerase chain reaction (PCR) testing device from Visby Medical, established in the US by Israeli Prof. Adam de la Zerda. PCR tests, (which are also used to diagnose the coronavirus), can accurately identify any bacterium or virus known to humanity. Currently, PCR tests are performed by huge laboratories and take several hours.
De la Zerda found a way to speed up the test and also miniaturize it to fit a personal handheld device. This is the first time a mini-PCR testing device has been developed, and results are said to come in within half an hour. Last week, the company received FDA approval for its Covid-19 test, and it hopes to receive similar approval soon for STD tests which were submitted for approval a few months ago. Visby’s test, like all coronavirus-related products, has been fast-tracked.
This Covid-19 test could be a game-changer for dealing with the disease. De la Zerda emphasizes that if someone who does a PCR test and gets a negative result will not be contagious for several hours, and even up to 24 hours. However, that person may be contagious the next day, if they were recently exposed to the disease and as the virus gets a grip on their body. Therefore, negative test results don’t exempt people who have been exposed to patients ill with Covid-19, or people with symptoms, from isolation.
But if you want to meet with your elderly parents, visit an oncology ward, work a nursing shift, go to a wedding, a club, or board a flight - a test that takes only half an hour to provide a negative result, and is performed on the spot, can definitely be the solution.
In the most optimistic scenario, if every person could do a test every day, and leave the house only if the results were negative - we would eliminate the pandemic without a vaccine and without medication. This probably can’t be achieved at the current rate of production and cost for Visby's test, but it could make possible "corona-free event" or "corona-free zone" scenarios for those willing to pay.
Wanted: Accurate and fast diagnosis
De la Zerda was once well-known as the youngest professor at Stanford University. "Today I’m not," he says, abashed. "I've grown up." He is now 36 years old.
"My background is in science," he says in a Zoom conversation with "Globes" from his home in Silicon Valley. But academic work was not fulfilling. "Scientists produce articles, but there’s something very unsatisfactory about writing a medical article, and stopping there. When my grandfather, who was a Holocaust survivor and a very practical man, heard I was going to be an engineer, he said 'Do you want to build devices? So, build devices people will use.’ That’s something which stayed with me, and I decided I wanted to understand how to build companies."
He joined a Silicon Valley venture capital fund as an Entrepreneur in Residence, and together they defined the need to invest in a medical diagnostics company which would be able to characterize infectious diseases, even before treatment. "Today, the field of infectious diseases is the only one where treatment is administered even before diagnosis is complete. It happened that I had to bring my little daughter to the emergency room and they couldn’t tell me if she’d inhaled a foreign object into her lungs, which is very dangerous because it can lead to pneumonia. To see if she’d inhaled an object, they would have to perform exploratory surgery, which is no trivial matter for a baby. Only after 24 hours did they come back with an answer, after which the correct treatment - for a virus - began."
This incident took place at Stanford Hospital, one of the best and most highly funded in the world, and yet the test results came in so late that it was necessary to make significant treatment decisions without complete information.
The need for rapid and accurate diagnosis of infectious diseases was defined.
"I've seen over 50 companies in two years," says de la Zerda. "But none provided both accuracy and speed." For Covid-19 PCR tests - that we’ve all come to know well in recent months - samples are heated and cooled about 40 times," says de la Zerda, to encourage replication of the viral genetic code. The amount of time that testing takes is determined simply by the speed of heating and cooling.
"What happens?" de la Zerda asks "Try cooling a hot cup of coffee. If it spills on your desk, it cools in a second because the surface area has increased. Yet surprisingly, they didn’t think about doing it for PCR." This is how the device was actually developed; increasing the sample surface area shortens the required heating and cooling time.
Commenting on the claim that Covid-19 tests in Israel are too sensitive and produce too many positive results, De la Zerda says, "PCR tests are very accurate for informing us about virus absence or presence. The significance of a small amount of virus is still unclear, as is whether the person is contagious. But the virus is there - unless the laboratory is contaminated, but laboratories know how to detect contamination." For this among other reasons, Visby's device is disposable - to avoid contamination.
And then, along came corona
The device’s prototype was developed in 2014. "And it was huge, but as an engineer I already knew it could be miniaturized. In 2018, we finalized the product, which is designed to diagnose sexually transmitted diseases. The big problem with STDs, which are the most common diseases tested for in the US, with about 50 million lab tests a year, is that many patients don’t bother to come in for testing, and those who do come in, sometimes disappear afterwards. And so, we lose some of the patients with positive results, but it’s impossible to treat them because - out of shame - they severed ties. Our initial goal is a test performed at the doctor's clinic providing immediate results, and enabling a prescription to be written for that person immediately, and stopping the chain of infection."
In trials with 2,000 test subjects against conventional PCR, it turned out that the device gives the same results. "We submitted the test to the FDA. And then we said, what else can we develop until they get back to us? After all, the product is suitable for every virus and bacterium. And then, along came the coronavirus."
So you’ve got FDA approval and you’re moving into mass production?
"Yes, mass production. It sounds romantic, but it's hard work. Supply chains are a complicated matter right now. Not only has the virus destroyed many supply chains worldwide, but we're also competing for materials against anyone in the world that develops PCR tests for Covid-19. But we’re going to invest a few months and tens of millions of dollars in this process. We’ve grown to 350 people working around the clock and we’re continuing to recruit people as fast as we can.
"We’ll start marketing at the places where the product is most needed: nursing homes, cancer centers, dialysis centers. We’ll increase our production capacity quickly to make as much impact as possible, but I hope we won’t be in this market for years."
Why?
"It would be a global tragedy if this was our business. We’re building the company for many more applications. The next thing is probably antibiotic sensitivity, which means figuring out which antibiotic a particular bacterium is sensitive to, so that it can be administered right away, rather than the trial and error process. Historically, this is something that PCR doesn’t do, but a few months ago, we demonstrated feasibility in this area. Unlike Covid-19 - which struck us but will also disappear - bacterial resistance to antibiotics is a problem that’s going to persist, so it’s our obligation as a technology company to develop devices for this problem."
What’s the device’s price point? Will it really enable people to test at home before they go out?
"If we make many millions of devices, it's not out of reach."
Asked when Visby’s rapid tests will arrive in Israel - also in light of a Tweet by Deputy Health Minister Yoav Kisch, according to which, "In the area of testing, innovative and groundbreaking Israeli technological innovations are under examination" - de la Zerga replied, "No comment."
Visby Medical
- Year of establishment: 2012 The company currently employs approximately 350 people
- Developed a personal handheld disposable device that enables reliable Covid-19 test results to be obtained within half an hour. The device received emergency approval from the FDA last week.
- In April this year, the company raised $165 million; a total of $300 million has been raised to date.
- Pitango Venture Capital Israel participated in both rounds, in addition to selected U.S. investors, including the well-known Cedars-Sinai Medical Center, and leading VC funds in the medical field.
30 minutes - and go! How the test is performed
- Swabbing (currently executed by medical staff; later it will be by the subjects themselves)
- Insert the sample into the box
- Press the button
- Liquid from the swab flows into chambers inside the device and undergoes heating and cooling processes
- A chemical reaction in the device checks for the presence of the virus
- Result receipt and analysis
Published by Globes, Israel business news - en.globes.co.il - on October 1, 2020
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