Groundbreaking at-home cervical cancer test granted 'breakthrough' status by FDA, fast-tracking approval process

Left: A mockup of an iPhone showing a Teal Health chat screen next to the Teal Wand cervical cancer testing device. Right: The Food and Drug Administration campus

Teal Health is a woman-led company ready to revolutionize cervical cancer screenings in the United States.

The company is behind the proprietary Teal Wand, an at-home self-collect device that aims to improve rates of screenings and provide a comfortable and accessible alternative to traditional pap smears.

A Teal Wand cervical cancer screening device by Teal Health
Photo courtesy of Teal Health

And now, the U.S. Food and Drug Administration has granted the Teal Wand with Breakthrough Device status; a designation awarded to medical devices that the FDA considers “life-saving” or “life-changing.” 

“The FDA has recognized the importance of Teal Health’s ability to increase access to screening and wants to do their part to help accelerate the time to market by giving us priority review and feedback,” Teal Health CEO and co-founder Kara Egan told Good Good Good.

FDA Breakthrough was awarded after reviewing Teal Health’s promising clinical trial data and will grant the company priority status as it submits its final study data for FDA review.

Teal Health co-founders Dr. Avnesh Thakor and Kara Egan
Teal Health co-founders Dr. Avnesh Thakor and Kara Egan. Photo courtesy of Teal Health

“We will still be held to the highest of standards, as we should — this is a nationally recommended cancer screening and needs to be taken very seriously,” Egan continued. 

“We have completed our clinical trial and are on track to submit for FDA review and approval in the next few months. We look forward to working with the FDA for an expeditious process upon submission.”

What is the Teal Wand?

The Teal Wand, which is designed for a broad range of bodies and health literacy levels, was initially tested in a 215-person study that proved women were able to collect an adequate sample — and that the experience was much preferred to traditional methods.

Patients use the Teal Wand to comfortably collect their own vaginal sample for cervical cancer screening from the privacy of their homes or health clinics. Then, they mail their sample to a laboratory for testing for primary screening of high-risk HPV.

Close-ups of the Teal Wand device on a turquoise background
Photo courtesy of Teal Health

Lastly, using the Teal Health online portal, users receive clearly communicated test results, have direct access to women’s health providers, and may receive assistance to find follow-up care.

In Teal Health’s initial studies, 97% of participants said the device was “easy” or “very easy to use,” and 94% said they would choose the self-collect method over the current standard of clinician collecting. 

“I think this is a huge win for women’s health. For far too long women and our experiences have been overlooked as a part of healthcare and research. It wasn’t until 1993 that women were required to be a part of clinical trials,” Egan said. 

“It has been great to see the FDA recognize Teal Health’s solution with both the Teal Wand to collect a sample, and the telehealth solution to be able to increase access to screenings. Increasing access to care is critical to addressing the women’s health gap in the U.S. and this is a big step towards closing that gap for millions of women.”

Closing the cervical cancer screening gap

Teal Health joins a shortlist of companies that have received Breakthrough Designation within the category of microbiology, which accounts for less than 4% of all Breakthroughs awarded since the program’s inception nearly ten years ago. 

The prioritization of self-screenings makes sense, as health organizations have been working hard to increase rates of cervical cancer screenings across the country.

Cervical cancer is the second leading cause of cancer death among women aged 20-39, even though it is preventable and is curable 92% of the time

More than half of cervical cancer cases are in people who are not routinely screened, which is in large part due to barriers such as discomfort during the exam, as well as a lack of information, time, and access. 

With one in four U.S. women not up-to-date on their cervical cancer screening — which Egan said adds up to an estimated 20 million people — it’s clear the current methods are failing.

A mockup of an iPhone showing a Teal Health chat screen next to the Teal Wand cervical cancer testing device
Photo courtesy of Teal Health

Egan said another major barrier is simply that in-office cervical cancer screenings “can be especially difficult for people who experience pain or discomfort, have a history of trauma, or do not identify as female.”

Fortunately, self-collect models work. When the method was offered to all women in Australia, screenings increased 50-fold within its first year, and the county is now on track to eliminate cervical cancer as a public health concern by 2035.

Following Teal Health’s initial study, a nationwide clinical trial (called “SELF-CERV”) took shape last year, following 17 leading health organizations and more than 600 participants — all spanning different races and ethnicities, socioeconomic statuses, and sexual and gender orientations.

“The Teal Wand and self-collection really resonated with our patients and they were excited to be a part of the SELF-CERV trial,” Clair Kaplan, the Director of Clinical Research and Principal Investigator at Planned Parenthood of Southern New England, said in a statement. 

“We saw upwards of an 80% enrollment rate, which more than met our expectations. I am honored to have been part of the efforts to advance cervical cancer screening and create more options for patients to get the care they need.”

In addition to the FDA’s support, and the evident success of the clinical trials, Teal Health has been financially backed by some big names, like Chelsea Clinton’s Metrodora Ventures and Serena Williams’ Serena Ventures.

Chelsea Clinton speaks into a microphone
Chelsea Clinton. Photo courtesy of Lorie Shaull (CC BY 2.0)

This latest milestone is proof that they’ll soon be seeing a return on their investments — both in Teal Health and in a better future in women’s health.

“The Teal Wand achieving an FDA Breakthrough Designation is a watershed moment for women’s healthcare, and brings us one meaningful step closer to eradicating cervical cancer,” Clinton said in a statement. 

“Women need better access to screening and early diagnosis for cervical cancer so that potentially life-saving care can be accessed as soon as possible, and with Teal Health, they will.”

Header images courtesy of Teal Health and FDA

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May 8, 2024 3:00 AM
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