Israeli lab puts PCR testing in the palm of your hand

Visby Medical, founded by Israeli-born Adam de la Zerda, has found a way to speed up the test and also miniaturize it to about the size of an iPhone

 PROF. ADAM De La Zerda of Visby Medical: COVID is a great example of the diagnostics world changing. (photo credit: Courtesy)
PROF. ADAM De La Zerda of Visby Medical: COVID is a great example of the diagnostics world changing.
(photo credit: Courtesy)

NEW YORK – As 200 people packed indoors at New York’s National Press Club recently, guests were confident that coronavirus was not one of the attendees.

Half an hour before entering, partygoers provided a nasal swab. Coronavirus test results were generated almost instantly, using the FDA-approved single-use test developed by Visby Medical, a company founded by Israeli-born Prof. Adam De La Zerda, which could be a game-changer for dealing with the virus.

With COVID-19 breakthrough infections on the rise around the world, the need for rapid and reliable COVID testing remains strong. Currently, polymerase chain reaction (PCR) tests are performed by massive laboratories and take several hours or even days.

Visby Medical, which employs about 350 people working around the clock, has found a way to speed up the test and also miniaturize it to about the size of an iPhone. This is the first time a mini-PCR testing device has been developed, and results are said to come in within 30 minutes.

The company was established in 2012, initially to develop STD diagnostic rapid tests. While still seeking FDA approval for the sexual health tests, when the pandemic hit, Visby quickly pivoted to COVID tests, which they received fast-track approval for (like all coronavirus products).

PCR tests processed by AID Genomics (credit: AID GENOMICS)PCR tests processed by AID Genomics (credit: AID GENOMICS)

Between meetings with investors and pharmacies, Silicon Valley-based De La Zerda, 36, who was once well-known as the youngest professor at Stanford University, sat down with The Jerusalem Post at the Yale Club in midtown Manhattan, where he explained how his team was able to scale the complexity of a “sofa-sized” PCR test down to a device that fits in the palm of your hand.

At this stage in our pandemic response, at least in the US, there are many types of COVID-19 testing available. These include lab-based PCR, which are highly accurate and can generate results in under 12 hours, as well as rapid antigen tests, which have been purchased and distributed by the millions by the US federal government. What do you see as the primary advantages of the Visby COVID test compared to these tests?

In the world of diagnostics, whether we’re talking COVID or anything else, you need to make a choice. Do you care about speed or do you care about accuracy? It’s very hard to get both at the same time. Antigen testing is fast and can be used at home, but it can be wrong 30% of the time. PCR results would make you feel comfortable visiting an elderly person, but the problem is you can’t get results here and now. Sometimes it even takes longer than 12 hours. Once you get the results, it will tell you that you were negative a few days ago, but what does that mean about you right now? What if you got on a flight within those 12 hours and one person sneezed?

What is the trade-off for such a small test?

There really isn’t one. Our results are essentially 99% accurate. A traditional PCR machine is about the size of a sofa. When we miniaturized it into this [Visby test], there was no compromise in the accuracy. If you’re a virus, from a biophysics point of view, you can’t tell the difference between this and a sofa-sized machine.

Truly anyone can carry it at any time. Another benefit is you can run multiple tests in parallel. The US Olympics team used it this summer before going into Tokyo to test over a thousand athletes.

Have any independent studies compared the accuracy of the Visby device to that of conventional lab-based PCR? What were the results?

Yes, plenty. We’ve been running our own studies for the FDA. We go to the large academic centers running the clinical trials. Once we got FDA approved, we got the devices out to customers and many decided they wanted to run their own independent studies, including the Lancet, one of the best medical journals in the world.

What is your average price per test?

Currently, the test is only being sold to doctor’s offices. Each vendor sets the price. For our other two products, we intend to get them into pharmacies so people can use them at home. Although, we probably won’t take our COVID test there.

Can you tell us about the other two products? What are the diseases that Visby targets beyond COVID? Are STDs your main focus? How will you compete with companies like Everlywell and LabCorp’s Pixcell that sell home collection kits for STDs at CVS and Walgreens? Is your main advantage the fact that results come back in 30 minutes vs 24-48 hours? Can rapid antigen and antibody tests yield the same benefits or is your PCR test more accurate?

[Before the pandemic hit,] our original focus was the sexual health test. Our other is a full respiratory test, Flu A, Flu B and COVID.

COVID is still important, but it’s not the only respiratory infection, especially going into the winter season.

In the world of sexually transmitted infections, the only option currently is getting an at-home collection kit. That gives a very different journey for the patient, because they collect a sample, put it in the mail, FedEx it back to the lab, and then a lab still runs the test. So they promise you results within three days, but you can’t get it right here, right now.

What we can do is actually give results immediately, in 28 minutes, like the COVID test. Imagine what this could look like in a home environment.

If a women at home is worried about some symptoms she’s having, she can go into her telemedicine app, put in the symptoms she’s feeling, trigger a prescription which hopefully insurance will pay for, and then a delivery service like Uber or DoorDash will come knocking on your door and deliver within 20 minutes. She tests herself, gets a result and then most importantly, we aren’t just leaving her hanging at home with a chlamydia diagnosis. We give the full process from ‘I’m worried” to a definitive diagnosis to this is what will make you better. Best of all, she never has to leave home. There’s no stigma, just ownership to take control of health from the convenience of home.

Your STD test currently only applies to women; will you be expanding to men?

Yes. We just had to pick one to start with. In the case of sexually transmitted infections, men often carry them but don’t show symptoms or suffer long-term consequences. In women, it can lead to infertility and ectopic pregnancy, which is life threatening.

Plus, as my wife would say, women are just more important in general.

Historically diagnostics have received less interest from venture capital investors as compared to new drugs and medical devices. Do you see that changing as a result of the pandemic?

I think it is changing. If you think about why that’s the case, it’s a question of how much value did you create. In the diagnostic world, we educate you about the condition of the patient. But what’s the value there? It’s only relevant if you’re going to actually do something different now. COVID is a great example of the diagnostics world changing. If you tell someone they are positive right here and now, they will do something differently. They will go home and quarantine. If you tell someone they have a 1% chance of developing a disease later in life, they aren’t going to make any changes.

Since the pandemic, you certainly see a lot more interest from the business community.

Israel’s reputation as the Start-Up Nation has mainly derived from successes in hi-tech and computer sciences, rather than the life sciences. Do you see this changing post-pandemic?

I haven’t been living in Israel for about 16 years, but I go back to visit family quite often. It’s a special place in my heart. There are actually quite a few cool medical device companies coming out of Israel. But you’re right that hi-tech is very strong there. I think generally, a challenge in the medical device world is that you want to be close to the market and the US market is incredibly large and strong.