The FDA grants trans-inclusive at-home cervical screening device a priority review
The new device breaks down barriers for LGBTQ+ people to access life-saving cervical screening. (@teal.health/Instagram/Getty)
The U.S. Food and Drug Administration (FDA) has granted a priority review for a trans-inclusive cervical screening at-home test to become approved in the US, and we think it’s high time for a change.
For women, trans and non-binary people with uteruses, undergoing a regular cervical smear to prevent and detect cervical cancer can be an unpleasant experience due to the cold and down-right uncomfortable speculum used. Some gender-diverse people also experience gender-based discrimination in such appointments.
The outdated device used in pelvic appointments to separate the vaginal walls can be cold and uncomfortable. The clamp-like instrument was invented in the mid-19th century and hasn’t adapted much since its bleak origins.
But the wait for a trans-inclusive and women’s-forward cervical screening at-home test might not be much longer, as the Teal Wand has been granted Breakthrough Device Designation status from the FDA. This means once the women-owned brand Teal Health submits its final study, it will be fast-tracked for a review.
This status is reserved for devices which the FDA believes could provide more effective diagnosis or treatment of life-threatening diseases, as well as their potential to benefit populations impacted by healthcare disparities.
Self-collected cervical screening tests actively reduce barriers for women and LGBTQ+ people facing healthcare-based discrimination. In the UK, LGBTQ+ people are less likely to access vital screenings, with 15 per cent of lesbian and bisexual women over 25 never having had a smear test, compared to seven per cent of women over 25 in general.
The new device allows people at risk of cervical cancer (all those with a cervix who are or have been sexually active) to perform their pap smear in the comfort of their own home with less discomfort, nerves and pain, compared to in-clinic collection methods, according to clinical trial results.
The tool combines a wand designed to fit all bodies”, a dial which “moves up and down to extend and retract the sponge”, and a soft sponge which collects the cervical cells for testing.
Similar self-collection screenings for cervical cancer are already available in other countries. In Australia, the government introduced such tests in July 2022.
