FDA approves revolutionary device as alternative to Pap smear

Washington DC - The US Food and Drug Administration has approved an at-home screening tool as an alternative to Pap smears by a gynecologist, the company behind the device said this week.

The "Teal Wand" – a self-collection vaginal swab shaped like a tampon and developed by Teal Health – will be available online for individuals aged 25 to 65 who are at average risk for cervical cancer. © Collage: Nicole Morrison / Teal Health / AFP

The "Teal Wand" – a self-collection vaginal swab shaped like a tampon and developed by Teal Health – will be available online for individuals aged 25 to 65 who are at average risk for cervical cancer.

Users request a kit online, have a brief visit with a telehealth provider to gauge eligibility, and then the kit is prescribed. They then collect the sample and ship it to a lab for analysis.

Cervical cancer, which affects the lower part of the uterus, is diagnosed in about 0.6% of women.

Although HPV vaccination and regular screening are highly effective at preventing the disease, more than one in four women fall behind on routine appointments.

"When we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day," Teal Health CEO Kara Egan said in a statement.

The Teal Wand tests for high-risk strains of human papillomavirus (HPV), the primary cause of cervical cancer.

Is the Teal Wand as effective as a Pap smear?

A large clinical trial found its accuracy comparable to a traditional Pap smear, which requires a speculum and is often cited as a barrier to screening due to discomfort.

Most sexually active people will contract HPV at some point, though only a small fraction develop cancer.

Teal Health did not disclose pricing but said it is in talks with insurers to ensure affordability. The product will launch first in California in June.