FDA Puts Teal Health on an Accelerated Path to Market for our At-Home Cervical Cancer Screening

This is a Big Deal. Teal Health’s at-home cervical cancer screening has received FDA Breakthrough Device Designation, putting it on an accelerated path to market based on our ability to increase access to this life-saving screening. This designation was given based on the strength of the interim results from our clinical trial. And, on top of that, we’ve since finished our clinical trial in record time, so when we say at-home cervical cancer screening is one step closer to becoming a reality in the US, we really mean it! This is a huge moment for women’s health, for the company, and for me who is in awe of our incredible team that is making it all happen. 

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A woman’s experience matters

Accelerating our time to bring at-home cervical cancer screening into the hands of women is critically important. Today, the screening is done in the office with a woman in stirrups, and the provider collecting a sample with a speculum and brush. It’s invasive. It’s uncomfortable. It’s inconvenient. And it’s causing a national health crisis. 1 in 4 women in the US are behind on their cervical cancer screenings and it doesn’t need to be like this. Teal is committed to closing the screening gap and enabling women and people with a cervix to catch up on this screening comfortably, conveniently, and privately from home. Cervical cancer is nearly entirely preventable through regular screenings; no one should be dying of cervical cancer in the US.

At Teal, one of our core beliefs and design principles is that a woman’s experience matters. Far too often healthcare overlooks the preferences and needs of women. So we’ve designed an end-to-end screening experience to increase access, by removing most barriers a woman might have. The Teal Wand allows a woman and person with a cervix to comfortably and privately self-collect their own sample, removing the barriers associated with fear, discomfort, or trauma. 97% of women in our initial study said it was very easy or easy to use. Additionally, our Telehealth platform will make care accessible and convenient addressing the barriers of time, availability, transportation, childcare, and financial burden associated with having to go into a clinic to receive care. 94% of women in our initial study said they would prefer Teal to the current standard of care.

“I believe the speed of completing our clinical trial is a testament to what happens when you design for the person and not just the detection of disease.” 

People all across this country readily signed up to participate in Teal’s clinical trial because they want a better experience! We finished our study 2 months ahead of schedule and 33% larger than anticipated with over 600 participants. This is exceptional. To put it in context, 90% of studies have to double their timeline to reach their enrollment goals, of which most enroll less than 500 participants. I am so grateful to our dedicated Principal Investigators (PIs) and passionate participants, who allowed us to accomplish this. There is really something magical that happens when you design for and with women. 

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The FDA Breakthrough designation validates our commitment to excellence

We’ve designed the product so that women want to use it, which will increase access and adherence to screening, but at the end of the day safety and efficacy are paramount. We are trying to move a nationally recommended cancer screening into the home to increase access and save lives. This is a really big undertaking. It's important for the health of women that we reduce these barriers, but we have to make sure that the at-home collection is clinically acceptable and meets rigorous FDA requirements. Simply put, it has to work well and be easy to use by all. That is what this clinical study aims to show and the Breakthrough designation was awarded based on the strength of our results at the half-way point of the study. We’ve worked hard to ensure we meet the strict FDA standards, because this is what women deserve. We have since finished the study and are preparing for our formal submission to the FDA. We are excited to work closely with the FDA to bring this life-saving device to market as quickly as possible.

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Small but mighty

Speaking of working quickly, the Teal team makes it all happen. I am in awe of this team. We are a small but forceful set of individuals who are just getting it done! The Breakthrough has been led by our clinical team, which is a powerhouse of 4 full-time individuals setting up and managing 17 sites across the country, countless analytical studies, and navigating FDA submissions and requirements. It’s unbelievable what they’ve accomplished. But this Breakthrough is also recognition of the whole solution Teal offers, which is the hard work of everyone on this team - from the physical product, to the software platform, to how we communicate and make the woman feel. It's all there, and that is everyone - and so that feels fantastic, unifying, and validating too. Teal Health is the first time I have truly had the benefit of working on something that is mission-driven. And I am learning that when you work on something that truly matters, where there is genuine passion, your capacity expands. And it expands because what you are accomplishing gives you energy. Our team is fueled by passion and that is why they are able to accomplish so much. I couldn’t feel more grateful to them all. 

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We are one step closer

*May 2025 Update: The Teal Wand is FDA-authorized. Check medical eligibility to get started and see if Teal is right for you.

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Our next step is FDA submission and review and thanks to FDA Breakthrough Designation, we will get priority review. We can’t provide a definitive timeline of when the Teal Wand will be available, but we will be submitting our data to the FDA soon and this Designation makes it clear that self-collect cervical cancer screening is a priority to enable increased access and help close the screening gap in the US.

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