The FDA has granted approval to Teal Health's at-home cervical cancer screening wand, the first self-collection tool for HPV screening in the U.S. Kara Egan, the cofounder and CEO of Teal Health, joined ForbesWomen editor Maggie McGrath talk about this milestone and what happens next.
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00:00Hi everyone, I'm Maggie McGrath, editor of Forbes Women. The FDA has approved the nation's first
00:09ever at-home cervical cancer screening. Joining us now is the founder and CEO of the company
00:16producing that screening. That company is Teal Health and that founder CEO is Kara Egan. Kara,
00:22thank you so much for joining us. I know it's been a very busy time for you since the FDA came
00:26out with this approval. Thanks so much for having me, I'm super excited to be here. So let's start
00:32with this announcement. What exactly does it mean? Yeah, so women today are supposed to be
00:39screened for cervical cancer. We often call it the pop smear, but as every woman knows, it's not a
00:44comfortable or easy thing to do. It's hard to find a doctor's appointment, the actual procedure is
00:49uncomfortable, and so now with the FDA approval, we're able to take that exact same cancer screening,
00:55but now do it from home using the Teal wand. And so now a woman can collect comfortably and privately
01:01from home for running on the same sample with the same accuracy. Sorry, same test with the same
01:06accuracy. Same test, same accuracy. How long did it take to get this approval? What was the process for
01:14you and for your colleagues at Teal? Yeah, so it has been a journey, but mostly in terms of trying to
01:21get it perfect, right? So at Teal, we really think about all of the experiences of a woman. So this
01:27was really important to not only be comfortable and collect an adequate sample, but give a woman
01:31confidence that she could do it. So we redesigned the whole product working with IDEO, which is the
01:38leading human-centered design company. And so that whole process took about a year where we really
01:42perfected and made sure that it worked. Then we almost took another full year to make sure that,
01:48again, it was collecting an adequate sample. What was the processing at the lab before we headed into
01:53the FDA clinical trial? The clinical trial itself was a 16-site nationwide study, the largest of its
02:00kind in the U.S. And what was actually really cool about the clinical trial is that one actually went
02:05quite quickly. So we kicked off the trial in November of 23 and finished enrolling in under six months,
02:12which was ahead of schedule and oversubscribed. And I think a big part of that was we had women
02:16raising their hands to be a part of this study. So anecdotally, 80% of women said yes to being part
02:22of the study. So from there, we finished the study, reviewed the results. The results were so
02:27exceptional that we received something called the FDA breakthrough device designation, which allowed
02:32us to be on the fast track through the FDA. So I would say all in, it took about five years to bring
02:37this product to market, but there were definitely aspects that actually went quite fast compared to
02:42other clinical trials. So you have the device there with you. How exactly does it work? And how
02:48foolproof is it? Because I have to say, as someone who can be a little hypochondriac,
02:53I feel like I don't know if I would trust myself to give myself a screening that is ultimately used
02:59to determine if I have HPV or something that could cause cervical cancer. Absolutely. And I think this is
03:05what the FDA study is so important for, right? Making sure that women have the confidence that if they did it
03:11at home, they're going to get the same accuracy as if they had gone into the doctor. So the way it
03:15works is it's designed very similar to a tampon. It is designed for all body types. So for some,
03:21it might go on only about two inches. For others, it might go the whole way. You insert it again,
03:25similar to a tampon, and then you extend the soft sponge. All you have to do is rotate 10 times.
03:31So again, as far as being foolproof, it's pretty foolproof. Then you just slide it back out,
03:36and then you take the sponge off actually and mail that to the lab. In our clinical trial,
03:4298% of women were able to collect an adequate sample. So when we say that this was designed to
03:47give a woman comfort and confidence, it really is. The other nice part is even if you did not
03:53collect an adequate sample, this test we use is called the Roche-Cobos HPV test. And it's a primary
03:59HPV test that's on all the leading guidelines. And it has an internal check. So if you did not collect
04:05enough sample, you would just get an invalid. You wouldn't get a false positive or a false negative.
04:10So what would happen in that rare case is we would just send you another kit to collect. And so again,
04:1698% of women could collect comfortably. 97% said it was easy or very easy to use. And then for anyone
04:22that wasn't, you know that you would just get an invalid. So as you talk about the clinical study,
04:28the 80% anecdotal yes rate, the 98% who said it's easy, what are the other figures that stood out to
04:36you and stood out to the FDA in terms of efficacy that our audience should know and understand?
04:42Yeah. So for us, there's kind of two parts. One, does it work, right? And so that's kind of like
04:47the safety and efficacy that the FDA cares about. The other part is, will women use it, right? So the
04:53answer the first, the study results that are so great is that we had the same accuracy as the
04:58doctor collected samples. So we had a 96% accuracy, which is really best in class. Can't really beat
05:05that. So that was fantastic. And we matched the doctor exactly with that 96%. So that was kind of
05:11the first piece. Does it work? Yes. And then the second is, do women want it? And so 94% of women in
05:18our clinical trial said that they prefer this to the standard of care. So I think that's kind of
05:23the resounding, yes, you know, women want this. And like, we have the data to show that they can now
05:29trust it and confidently take their sample at home. So it's been part of an FDA clinical study.
05:37When will it be commercially or mass market available? Yeah. So we've been working hard at this
05:44for five years for the clinical trial, but we've also been building the whole entire solution.
05:49So the way it works for TEAL is you would come to the TEAL website, you would request a kit. You'll
05:54meet with a TEAL medical practice provider who will review your eligibility, explain how it works,
06:00and then write the prescription for the device, as well as order the assay at the lab.
06:05Once you do that, the kit will come at home, you'll collect comfortably. Again, in addition to the 98%
06:12collecting a sample, 97% saying it was easy. On average, it takes less than five minutes,
06:16right? So you quickly collect your sample, then mail it back to the lab and all the prepackaged
06:21material that's sent to you, envelope that's sent to you. It's then processed at the lab. And then
06:27the results come back to TEAL. And we review the results with the clinician, and then they release
06:32them to you. If you had an abnormal result, you would speak with the clinician at that point as well,
06:37via telehealth. And we would explain your next steps. Like, this would be the same as if it was in
06:42the doctor's office, right? There are next steps for people. It's a triage, right? It's a screening
06:46that leads to a triage. And so for that, we would refer you into your in-person triage. And so all
06:52of this is built, right? So we've been eagerly waiting this day. And so we have amazing clinicians
06:57lined up. We have a full platform built end-to-end, and we're planning on launching in June. So just like
07:03less than a month away, women starting in California will be able to get the TEAL bond.
07:07So you're starting in California, and then we'll have to go state by state, I imagine,
07:12given state regulations? Yeah. So for us, it's really important that this is covered by insurance.
07:17And so we started in California, both because this is where we are, but also it allowed us to start to
07:22get in network. So we're already in network with Aetna, Blue Frost, Blue Shield, Cigna, and United
07:27inside California. And so that's really important. We're also speaking to national providers about
07:33rolling it out for their entire member base nationally. And so that's really what's going
07:37to accelerate the path into other states. Once we have national coverage, it just makes it easier
07:42for us to make sure everyone can access it. As I think about patient populations who might need to
07:47access this, and I know you've spoken to the press about populations that don't go for their annual
07:52OBGYN visit and so aren't getting these screenings. I'm wondering about folks who may not have
07:58insurance through work or on Medicaid. So is Medicaid part of the coverage options for TEAL?
08:06Yes, we are working to get into Medicaid in California and other states as well.
08:10We are already in network with Medicare, which is the first step towards getting Medicaid.
08:15But the interesting thing back to what came out of the study is, well, there are definitely populations
08:19that are less likely to be screened. So of course, uninsured or 40% less likely to be on top of their
08:25screening. What we found is it was near universal. One in four women are behind in their screening.
08:30So we mapped really, really closely to the U.S. demographics across race, ethnicity, income,
08:36education, type of insurance, where you're located. And it did not matter who you were or how you slice
08:42that data. One in four women were behind on their screening. So even if you had employer-based
08:47insurance, one in four women were behind on their screening. It was rather shocking, but not surprising
08:52when you think about what makes it hard to get a screening, right? It's, can you find a doctor
08:57that's available? And, you know, do you have time in your day? And the reality is everyone feels those
09:02two pain points. That's interesting. How do OBGYNs feel about this as an option? Because I know that my
09:10own uses an annual physical or, hey, you need to renew your birth control prescription, so come on in
09:17and let's do it all at once as kind of the carrot here. Are they open to patients doing this at home?
09:24Yeah. I mean, every single doctor wants to make sure women have access to cervical cancer screenings.
09:30As I mentioned in the beginning, their main concern was just, does it work as well, right? And so that's
09:34the really nice part about our clinical trial. It does. It has the same accuracy. What we're actually
09:38finding, as you mentioned, there's other things that are happening in that doctor's visit, right?
09:42While people might be thinking to come in because of the cervical cancer screening,
09:46what this now allows the doctor to do is have more time for those visits or for that,
09:51those other conversations that they would be having. So this is not to replace your relationship
09:57with your doctor. It's just to give women a better way to screen, right? And so those two are not at
10:02odds with each other. Everyone wants to make sure women are screened back to point one and four are
10:07behind. It's an entirely preventable cancer. Every doctor wants better ways. We just, this is about more
10:13care. Zooming out, you mentioned this has been five years in the making and you are the, not just
10:19the CEO, but the founder of this business. What gave you the initial idea for Teal Health?
10:25Yeah, yeah. So I'm a CEO and co-founder. And so what gave me the idea is a combination. It's actually
10:31the combination of the two of us. So I've always been super passionate about women's health and using
10:37kind of best modern practices to reach a woman where she is, right? So my background is I used to
10:44be a health tech investor and then I worked at a couple of different tech companies and then was a
10:48software investor as well. And so healthcare just can use, you know, can learn a lot from all of these
10:55industries and how they're reaching out to their patients and how they're communicating and how
10:58they're engaging. And that can range from using really modern technology, like, I mean modern, but
11:05like text, email, things like that, but also how we brand and communicate with people, right? So
11:11speaking to a woman in a way that she wants, feels seen and understood, like we care about everything,
11:16like our box, we research like the first words that welcome you into the box and how it made a woman
11:22feel. So all of this branding and stuff can kind of really reach women better through healthcare.
11:27And then, as I think we mentioned in the beginning, you know, one of the biggest pain points for women
11:31is the cervical cancer screening, right? And nobody enjoys the current way. And so it's a really
11:36beautiful moment to kind of bring the cervical cancer screening and telehealth together. And so
11:42I kind of came with the telehealth piece and my co-founder came with the initial prototype of a
11:48self-collection device. So what's next? Obviously rolling out in California and eventually getting into
11:55every state will keep you busy in the near term. But if I were to speak to you in a year, is there
12:01a statistic that you would hope to have changed or a metric that you hope to have reached or
12:07some sort of mile marker that you're envisioning?
12:11Yeah, that's a great question. I mean, I think we're really laser focused on cervical cancer right
12:17now, right? So there's plenty to address in women's health, but cervical cancer is huge. And,
12:22you know, all women ages 25 to 65 are supposed to be screened. So we're really focused on making sure
12:27that that happens. So I think for us, it would be metrics around making sure more women are screened.
12:33So I think just numbers of women screened is going to be something that we look at. I think just changing
12:39the conversation, you know, women often don't know what the pap smear is for. They just kind of know
12:46they're supposed to get one. They're not aware that it's a cervical cancer screening. So really kind of
12:50changing the way that we talk about that screening and making sure every woman knows that she's
12:55supposed to get screened for cervical cancer. I think just even having that be part of the
13:00conversation is going to be a huge thing for us. And I think it's something we can do and something
13:04we're already seeing, right? Like all of this coverage about Teal being at home, it's like there's
13:09this pain point, but there's this conversation that needs to be happening. And so I think those would
13:15be the two that would look to. Well, we will have to have you back as Teal continues to grow
13:21and expand. But in the meantime, congratulations on the FDA approval and good luck with the rollout.
13:27We so appreciate your time and your insight today. Thank you. Thanks for having me. And thanks again
13:32for getting the word out about cervical cancer. Appreciate it.