Teal Health, a company led by women, is dedicated to ensuring that all women and individuals with a cervix in the US receive cervical cancer screening.

They have achieved a significant milestone by receiving Breakthrough Device status from the US Food and Drug Administration (FDA) for their innovative at-home self-collect cervical cancer screening device, the Teal Wand™.

This designation, granted based on promising midpoint clinical trial data, gives Teal Health priority status for FDA review upon submission of final study data. The FDA Breakthrough program expedites access to medical devices that could improve diagnosis or treatment of life-threatening diseases, particularly benefiting populations facing healthcare disparities.

With 1 in 4 US women not up-to-date on cervical cancer screening, this FDA Breakthrough status is especially crucial. It aims to provide access to individuals who rarely or never undergo screening or cannot undergo a standard exam with a speculum, offering them the option to self-screen at home or in more convenient locations.

Teal Health now joins a select group of companies in the microbiology category to receive this designation, underscoring the rarity and significance of this achievement since the program's inception nearly ten years ago.

The Teal Wand is a proprietary device designed to empower individuals to collect their vaginal sample comfortably and confidently for cervical cancer screening, eliminating the need for an invasive exam. Users can mail their sample to a laboratory for testing on an FDA-approved diagnostic test for high-risk HPV (human papillomavirus), as recommended by medical guidelines.

Through the Teal Health patient portal, users will receive clear test results, access to women's health providers, and assistance in securing follow-up care or procedures, as needed.

In a study involving 215 participants, the Teal Wand proved effective and highly preferred, with 97% of women finding it easy to use and 94% expressing a preference for self-collection over the current standard of care.

Additionally, 87% stated they would be more likely to undergo screening if the Teal Wand were available.

Expressed gratitude to the team, study participants, and the FDA for recognizing the significance of Teal's solution in addressing the gap in women's cervical cancer screening.

The company's nationwide clinical trial, SELF-CERV, involving 17 leading health organizations and over 600 participants, demonstrated the device's effectiveness across diverse demographics, exceeding enrollment goals and timelines.

Cervical cancer, largely preventable and curable when detected early, remains a significant health concern, especially among underserved populations. Barriers such as discomfort during exams, lack of information, time constraints, and access issues contribute to low screening rates.

Self-collection presents a promising solution to increase accessibility and preference, as evidenced by its success in other countries like Australia.

Emphasized the public health benefit recognized by the FDA in granting Breakthrough status to the Teal Wand. The device's clinical performance underscores the potential for at-home self-collection to become a viable option for eligible individuals in the near future.

Teal Health looks forward to collaborating closely with the FDA to expedite this option for women and individuals with a cervix in need of accessible screening solutions.





Source: prnewswire.com

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