Teal CEO talks FDA approval of at-home cervical cancer screening

The FDA has greenlit the first at-home device to help screen for cervical cancer—no stirrups, speculums, or awkward small talk required.

The device, made by women’s health company Teal Health, is a wand with a sponge-like end that patients can use to self-collect vaginal samples. The service also includes a virtual visit with a Teal provider to discuss your history before receiving a device and another after if follow-up care is needed.

The samples are mailed to a lab for primary human papillomavirus (HPV) testing, the American Cancer Society’s recommended method for cervical cancer screening since 2020. (It’s an alternative to the dreaded Pap smear, which is a less accurate test.)

As co-founder and CEO Kara Egan told us: “It’s not the ‘Pap smear from home’ because you shouldn’t be doing the Pap smear anymore. You should be doing primary HPV [testing].”

A US-based study found Teal’s wand was just as effective as a test done by a doctor.

The hope is patients will be more willing to get tested when they can do so themselves from home. Right now, 1 in 4 patients aren’t up-to-date on their screenings, and a 2022 survey of 20,557 women found most who had missed their screenings didn’t know they needed to get them.

Ahead of the device’s planned California rollout in June, Egan talked to Healthcare Brew about the significance of its approval and the company’s future plans.

This interview has been edited for length and clarity.

We’ve been testing for cervical cancer for decades. Why do you think no one has invented an at-home collection method sooner?

I think the biggest reason was we never asked women if they wanted something better.

And then there’s the technical component…When you were looking at just the Pap smear, you had to get cervical cells, and that’s really hard to do. Primary HPV can be done just as well with vaginal cells.

How did you go about designing the wand?

I would say for the wand, it was making sure that it was comfortable, making sure that it actually could collect an adequate sample…The other part is giving a woman confidence that she did do it right.

It feels like someone’s holding your hand a little bit…Most women will have negative results, but for the few that have positive results, how does that feel? Do you feel like you got the information that you need? And are you able to speak to a provider right away to understand your next steps? And so we built that whole journey in.

How are insurers responding?

We are in-network for the telehealth side—and then you start to work with [insurers] once you’re through the FDA to get the full thing covered. But what we would say is it has been really positive. We’ve had a lot of large national payers proactively reach out to us, even ahead of the FDA [approval], to understand how it’s going to work and make sure that they can get it for their members. So we are in negotiations right now to get this covered nationally with no cost-sharing.

You’re launching in California in June. How are you preparing to manufacture and distribute the wand after that?

We are encouraging everybody to join the wait list no matter what state you’re in because how we move to other states, or just start to address the other states, will be through the wait list. In the beginning, we’re going to start smaller…We want to make sure everything’s perfect in terms of the experience on the telehealth platform side. So we’ll start in the hundreds in the first couple months, but then the idea is we can quickly scale. All of our manufacturing, all of our lab partners, everything can handle hundreds of thousands, if not millions [of patients].

How did receiving FDA breakthrough device designation influence the development and approval process for the wand?

The FDA breakthrough was [based on] our clinical trial data, which was already wrapped and exceptional. So it didn’t affect development, but it did put us on what’s considered the fast track for the FDA. It was great. The FDA was super responsive. We had almost daily interactions with them.

Are you investing in any particular marketing or awareness campaign?

We’re working on educational campaigns…I think education is going to happen on its own because everybody is gravitating toward the fact that they want a better way [to test]. It is hard to find a doctor’s appointment, it is hard to find time out of your work or childcare, and then the experience itself is not positive, whether it’s painful for you or just kind of violating and uncomfortable.