Visby Medical gains FDA approval for Sexual Health Click Test


Associate Editor Lindsey Carr sat down with Gary Schoolnik, MD, Visby Medical’s Chief Medical Officer, to learn more about the device’s functionality and application.

The U.S. Food and Drug Administration (FDA) recently issued 501(k) clearance for Visby Medical’s Sexual Health Click Test, a single-use, instrument-free polymerase chain reaction (PCR) diagnostic test for sexually transmitted infections (STI). The device can detect 3 of the most common STIs—Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV)—in less than 30 minutes via a self-collected vaginal swab.

Schoolnik is also a professor of medicine and Attending Physician in Infectious Diseases and Internal Medicine at Stanford Medical School and Hospital.

Visby Medical’s Sexual Health Click Test: What is it, and how does it work?

Visby Medical Sexual Health Click Test

Visby Medical has developed a palm-sized [test], about the size of the computer mouse. It's single-use, and it runs a full 40 cycles of PCR. It directly takes a clinical sample. In the case of the sexual health tests that have now been FDA-approved, It's a self- or health care-provided vaginal swab sample, obviously from a woman. It takes that sample, extracts the DNA from that sample, and then uses 40 cycles of PCR to amplify the pathogen DNA that was in that sample. It then displays the results in an easily read visual manner. It does all of this within 30 minutes.

The intent here is that when a patient presents to a clinical setting, it could be a clinic, an urgent care center, an emergency room, an STD clinic, a Planned Parenthood venue, that, if the patient is there, because of symptoms.

For example, a patient might come in and say, “I've noticed a change in my vaginal discharge,” or the patient might come in and say, “I'm so sorry to tell you, but I had a potentially risky sexual contact a few days ago, and I'm worried,” then the best clinic workflow for the maximal benefit of this device, would be for the triage nurse, for example, to say to that patient, “I think I understand your main problem. I think we should get you tested. To expedite that, we'd like you to go into the women's laboratory, which is right over here, adjacent to the waiting room, and you'll find directions for how to take a self-collected vaginal swab sample. I'd like you to take that and when you're done, just come out, please give it to me, and we'll start running the test. Even before you talk to our health care provider, and provide more history, and if necessary before you have an exam.

So at that point, that clinic would, within about 20 seconds of hands-on time, take that swab sample, put it into the device, using very simple transfer pipette that we have and provide in the box, and the nurse would just press three little buttons, plug it into a wall, a circuit, could even be battery-run. Then that patient can have a more complete history taken and a physical exam is conducted, for example, a pelvic exam if indicated.

At the end of that, because the test is complete within 30 minutes, the health care provider can say,” Please get dressed, let's come into my office. I'd like to discuss your results with you.” So that the doctor will know on that initial clinic visit, what the patient has come in for, and also what the results of the test are. The way that might go is the physician might say, you know, “I have some very difficult news to share with you, I'm afraid, I have to tell you, you have gonorrhea. The good news is that because we have a test result showing that today, we can complete treatment today. And that treatment is 99% effective. Let's talk a little bit now about gonorrhea and why it's important for a woman's health.”

And then the doctor might describe pelvic inflammatory disease—a leading cause of infertility—ectopic pregnancies, and chronic pelvic pain. The doctor might then say, “Let's talk a little bit about safe sex practices so that this doesn't have to happen again.” And then the doctor might say, “We ought to talk for a moment about your sexual partner because that person needs to be treated as well. And because we have made a diagnosis in you, we actually can prescribe treatment for your sexual partner, and they don't even need to come in for an exam.” That's expedited partner treatment.

And what I like to say is that having a test result at the same time a patient presents with an illness is a huge advantage. First of all, and most obviously, whatever treatment you give is driven by an actual test result. It's not based on clinical judgment, which, as physicians, we always use clinical judgment. There's no way we can ever dispense with it.

But it could also be called an educated guess that is when we prescribe medicines when we don't actually know exactly what we're treating. We run the risk of overtreating, that is, giving medicines to people that don't really have the disease. We also run the risk of undertreatment, that is, not treating people that really are infected. That, in turn, has serious consequences because, during that period when you don't have the results, the disease can spread, for example, up the fallopian tubes to cause pelvic inflammatory disease. A person can continue to transmit it to others.

We would very much like to know the result when the person first comes in, and use that result to select therapy. In the world of many STDs, although not all, treatment is highly effective. Once we know what we're treating, we can use the CDC guidelines to prescribe a certain treatment plan for a patient.

The other thing I would say that's a huge advantage, from my perspective when you have a diagnosis that's made on an initial clinic visit, is being able to engage in what I call the teachable moment.

That's the time when a patient's most ready to engage in a conversation with a clinician about what the significance is of the disease they have, and, and what the potential complications are, what the treatment is, and most importantly, how to avoid getting affected next time.

People really listen. If you say, “Gee, you know, I think you might be sick, but I really don't know what you have.” That teachable moment is not as intense, and it doesn't really have the same impact. Just putting my physician role before anything else, there's a huge advantage in the array of infectious diseases, to have a rapid and PCR level accurate result that you can believe and act on.

What kind of impact do you think this technology will have on sexual health and STD testing?

There’s a trend in infectious disease diagnostics very generally, but it's very obvious in the area of STDs that we want to bring these test modalities closer to the patient.

We could call them patient-side testing. And eventually, it's going to be testing at home, where people actually can obtain a device such as the Visby device, for example, at a pharmacy, take it home with them, and be tested in the privacy of their own home, perhaps with the support of a telemedicine hookup so that there they have the counsel and ultimately somebody has to generate a prescription and so that they can be tested, but still have all the advantages that come with telemedicine.

In the area of sexual health testing, that's a hugely important trend. The reason for that is that people are understandably reluctant to have a more public place where they're tested with a major fear, loss of confidentiality of some sort. These are diseases that people feel embarrassed about, and yet they're diseases that definitely need to be treated.

The COVID epidemic, in general, has accelerated this trend toward home testing and point-of-care testing enormously because it has elevated the use of telemedicine. If you've been to a physician in the last 12 months, very likely it was not in their office.

There are some things that have to be done in an office obviously, but there are many things that don't have to be, so telemedicine is now at a very different level than it was before the COVID pandemic occurred.

The future of STD testing

When we do surveys of potential patients, we find a huge interest in people being able to be tested at home. In the area of STDs, it's important that we also be able to get those results off the device and to the municipal, county and federal health authorities because two of the organisms that are tested in our device are reportable diseases. That’s how we track the movement of the chlamydia and gonorrhea epidemic in the United States is, we are hopeful that every case or most cases are actually reported to the CDC. It's also important in some cases for contact tracing, so that we can identify sexual contacts and get them treated before people spread their infection to others.

I think you'll find STDs leading the way for home testing. It will be different than what's now available, which of course, is the mail-in testing kit. If you go into Google and look for home STD testing, you'll find a number of different companies that will send you—by mail—a kit, to test yourself. That is, you take a sample, and then you mail it back to some central lab.

Then, usually, about 48 hours later, you will get a result from the central lab. What we're proposing is something that's quite different, you not only take the sample at home, you activate the device. And that means, within 30 minutes of taking the sample, you actually have a result that we know is equally accurate to the result you would have gotten had you set that sample off to a large laboratory.

Study findings

The reason we know it's equally accurate is because the clinical trial for the Visby device was actually published in The Lancet Infectious Diseases. It was all written by academic infectious disease and STD experts. That study was funded by the federal government. It compared the performance of the Visby device with large laboratory instruments, the kind of instruments that run in large laboratories and are, you know, six feet by six feet in size. They're very accurate, but it takes many, many hours, and sometimes several days to get a result from them. So, we're very interested in how to best and most appropriately put this kind of device into the home, because we think it will make a difference in STDs, which I like to call the other epidemic, right? It's the epidemic, which isn't seasonal, and it's not going to be here today, and gone in a few years. It's going to be with us for the long term.

Next steps for getting the Visby device into pharmacies and into the hands of the patients

So it's FDA-approved now for point-of-care testing, which means that it is being used and will continue to be used in all kinds of point-of-care testing venues. Doctors offices, retail pharmacies, urgent care centers, ERs, OB/GYN offices, and so on.

The next step of getting it over the counter (OTC) will require that we have a clinical trial demonstrating that it can be effectively used at home. So, we are gearing up to conduct a trial of that kind, and we have a fairly large group of people working on the OTC indication for this, and that comes in two flavors. There's over-the-counter RX, and then there's over-the-counter.

Over-the-counter RX simply means a doctor actually has to prescribe it and the patient can then pick it up. That's the easiest pathway via the FDA to start with. With just over-the-counter, it is out on the shelves of places like retail pharmacies, where patients can pick it up and obviously, with the full support of telemedicine and some means of deploying the data, go to a pharmacy to generate a prescription, and then to the CDC for the reportable diseases for surveillance purposes.

COVID-19 put sexual health on hold

This sexual health test was done over a number of years by a dedicated small team of scientists and engineers. We were about 60 people in size, and then the COVID pandemic occurred.

Even though we had completed six successful clinical trials with that sexual health device at that time, we sort of put it aside and pivoted the entire company to COVID. Can we build a COVID diagnostic test using exactly the same kind of device that looks the same from the outside? And we grew from 60 to 600 people in about three months. Many of those 600 people were on a manufacturing line where we actually began to build up to 10,000 of these devices a week.

We put our whole sexual health effort kind of on the side, and then returned to it about five months ago to complete all of the FDA documents that required for submission. So now, we're back in the STD plus COVID field, but the COVID pandemic did a lot for us. It built a huge manufacturing capacity that we didn't have before.

It developed our clinical trials team to a very large and capable group, our regulatory team to deal with the FDA. It really, in some ways, was a fortunate diversion for us, but if it hadn't been for COVID, we would be having this conversation probably a year and a half ago.

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