The first-ever at-home screening test for cervical cancer earned approval by the Food and Drug Administration on Friday, paving the way for the DIY device to be in the hands of eligible women as early as next month. And it’s already in-network with big insurers Aetna, Cigna, and Blue Cross of California.
Developed by femtech startup Teal Health, the Teal Wand, which is modeled after a tampon, was shown in clinical trials to have the same accuracy as the cervical cancer test performed in your OB-GYN’s using a speculum. To date, the company has raised a total of $23 million with funding from Serena Ventures, Metrodora, and Labcorp.
While the at-home test won’t replace your visits to the gynecologist where you can get a full pelvic exam and address other issues with your doctor, Teal Health CEO Kara Egan hopes its accuracy, convenience, and comfort factors will encourage more women to get lifesaving screening.
About one in four women are currently behind on cervical cancer screening, which along with the HPV vaccine, is a proven way to prevent the cancer from developing. Cervical cancer will kill more than 4,000 women this year.
In clinical trials, 94% of users said the Teal Wand was preferable to getting the test in a doctor’s office, and 86% of participants said they’d be more likely to stay up to date with cervical cancer screening if they could do it at home.
“All women prefer a better way,” says Egan. She spoke with Fortune about the Teal Wand and why some women skip out on potentially lifesaving care.
This interview has been edited for length and clarity.
Fortune: What problem is Teal Health aiming to solve in women’s healthcare?
Kara Egan: When we look at the top three reasons why women aren’t getting screened, it’s “access,” “convenience,” and “fear/discomfort.” But when you talk to real women, they explain it differently. Like, “I don’t get screened because I’m a mom and I have two young boys, and all the doctor time gets taken with them.” Another woman said, “I live in New York City and I can’t find an OB-GYN.” That’s an access issue, but we describe it in everyday terms like not being able to find an appointment or not being able to take time off work.
Teal addresses all of this. You can collect your sample comfortably at home. We wrap the experience with a telehealth solution, so you get access to doctors for both prescription and result review. It’s convenient and flexible—you can take the telehealth visit from home when it works for you.
Fortune: Walk me through how it works. How do I know I need a screening, how do I collect the sample, and how do I get my results?
Kara Egan: You start by visiting the Teal Health website and completing a short eligibility registration. Most people don’t know when they’re due, but based on your last screening and its type, it could be anywhere from one to five years. Most insurance will cover it every two years. If you’re unsure—just get screened.
We use the exact same test used in doctor’s offices—primary HPV screening, which is now the standard. The difference is that you’re collecting the sample using the Teal Wand at home. So you’d have a short visit with our clinician, and she’d explain how Teal is going to work. It takes about 10 minutes total. Then we ship the kit to your house. It’s designed like a tampon, which is something that every woman’s comfortable with. We designed this to really be both comfortable but also give a woman confidence that she is collecting enough sample. In our clinical trial, 98% of women collected enough sample for the test.
You can’t do it wrong. If not enough sample is collected, the result comes back as invalid—not a false positive or negative.
Here’s how it works: insert into the vagina to the back wall, extend, rotate 10 times, slide it back out, pop off the sponge, place it in the vial, and send it back to the lab.
The clinician knows both your new results as well as your past history. So coupling those two together is how we decide if you have any follow up appointments. And this is the exact same as if you had done it in person.
Fortune: That sounds simple enough. So why aren’t we doing this in doctors’ offices?
Kara Egan: Good question. It just hasn’t shifted yet. Even though doctors could allow in-office self-collection, the problem Teal solves is getting to the appointment in the first place. Most women choose Teal not just for comfort, but because it’s easier to get done.
All women deserve a better way. We have a problem with the way it’s currently being done, and that one in four women are behind, but all women who get screened are like, “I didn’t like that.” Why does it have to be like that? We’ve evolved the screening tests. We’re comfortable with screening at home. There was a lot of momentum to get this done, but a big piece of it was asking women what they preferred.
