Start-up wins FDA breakthrough designation for at-home cervical cancer screening solution

The US healthcare start-up Teal Health has received breakthrough device status from the US Food and Drug Administration (FDA) for its at-home cervical cancer screening solution.

The Teal Wand is a device that aims to help women collect their own vaginal sample for cervical cancer screening from their home or health clinic, without the need for an invasive exam.

FDA breakthrough, which was awarded after reviewing Teal Health’s midpoint clinical trial data, will grant the start-up priority status when it submits its final study data for FDA review.

The programme helps patients have more timely access to medical devices that could provide more effective diagnosis or treatment of life-threatening diseases and for their potential to benefit populations impacted by healthcare disparities.

With one in four US women not up-to-date on their cervical cancer screening, Teal Health says this FDA breakthrough designation is particularly significant in that it is aimed to increase access for people who rarely or never screen or who can’t undergo a standard exam with the speculum by having an option to screen themselves at-home or in more convenient locations.

Kara Egan, co-founder and CEO of Teal Health, said: “I am so grateful to the amazing team at Teal, our hardworking PIs and sites, the supportive participants in our study, and the FDA for recognising the importance of Teal’s solution to help close the women’s cervical cancer screening gap in the US.

“The speed of our study shows that if you design for and engage with women to advance women’s health, you’ll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long.

“This study and breakthrough designation is an important moment for women’s health.”

Late last year, Teal Health followed its initial study with a nationwide clinical trial, titled SELF-CERV, which included 17 leading health organisations and more than 600 participants.

The research was designed to validate the performance of the Teal Wand and compare results against a clinician collected sample with a speculum and brush.

The study, which completed enrolment for its initial FDA indication this month, received an overwhelming response from women, exceeding initial enrolment goals.

Lead SELF-CERV enroler, Clair Kaplan, director of clinical research and principal investigator at Planned Parenthood of Southern New England, said: “The Teal Wand and self-collection really resonated with our patients and they were excited to be a part of the SELF-CERV trial.

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

Cervical cancer is preventable and is curable 92 per cent of the time. However, it is the second leading cause of cancer death among women aged 20-39 and incidence is increasing among women aged 30-44.

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, lack of information, time and access.

Studies show that women of all races and socioeconomic levels experience these barriers, with native American, black and Hispanic women resulting in higher under-screened rates.

Self-collection, which has already been adopted in countries such as Australia, is thought to increase access to screening.

Trena Depel, vice president of clinical and regulatory at Teal Health, said: “FDA’s recognition of the Teal Wand as a breakthrough device acknowledges the important public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinician-based screening for cervical cancer.

“The clinical performance of the Teal Wand shows promise that an at-home self-collection device is possible in the near term and Teal looks forward to working closely with FDA to expedite this option to eligible women and people with a cervix.”