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FDA Approves At-Home Cervical Cancer Test

by Ethan Caldwell

FDA Approves At-Home Cervical Cancer Screening Device, Expanding Access to Care

CAPITAL — May 11, 2025 — The FDA has approved the Teal Wand, an at-home device for cervical cancer screening, promising greater accessibility. This new device allows users to collect vaginal samples at home, a notable advance in preventive care. The approval of the device is expected to expand access to care, and drive a paradigm shift in cervical cancer screening.

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FDA Approves At-Home Cervical Cancer Screening Device, Expanding Access to Care

In a move poised to revolutionize cervical cancer screening, the Food and Drug Administration (FDA) has approved the Teal Wand, an at-home vaginal sample self-collection device. This innovation offers a more accessible and perhaps more comfortable alternative to traditional Pap smears,especially benefiting women who find in-office procedures uncomfortable,painful,or inaccessible due to time constraints,disabilities,or other barriers.

The teal Wand: A New Approach to Screening

the teal Wand allows users to collect a vaginal sample using a sponge-tipped tool. This sample is then mailed to a lab for HPV (human papillomavirus) testing. HPV is the primary cause of most cervical cancers. Unlike Pap smears, which involve scraping cells from the cervix for microscopic analysis, the Teal Wand focuses on detecting the presence of HPV.

Did you know?

Cervical cancer is highly preventable with HPV vaccination and regular screening. However, approximately half of all diagnosed cases in the U.S. occur in individuals who have never been screened or are infrequently screened.

Shifting Paradigms in Cervical Cancer Screening

The approval of the Teal wand aligns with a growing trend toward HPV testing as the primary screening method for cervical cancer.As The New York Times noted, some authorities are now recommending HPV testing as the primary screening for cervical cancer. This shift is supported by initiatives like the National Cancer Institute’s Cervical Cancer ‘Last Mile’ Initiative, which aims to expand access to screening through self-collection methods.

national Cancer Institute’s Initiative

Last year, the National Cancer Institute launched a clinical trial network called the Cervical Cancer ‘Last Mile’ Initiative and teamed up with Roche, which provided a similar self-collection solution for participants. The cancer institute explained at the time that cervical cancer is highly preventable with HPV vaccine and regular screening, but half of all diagnosed cases in the US are of individuals who have never been or are infrequently screened. A self-collection device can vastly expand access to cervical cancer screening.

How the Teal Wand Works

Teal Wand users gain access to the company’s telehealth services, where providers offer guidance on proper device usage. The process involves detaching the swab from the wand, placing it in a provided vial, labeling it, and mailing it to a designated laboratory for analysis.

Accuracy and Availability

Teal Health asserts that its solution demonstrates comparable accuracy to in-clinic screening methods, based on its clinical study. The company plans to begin shipping wands to California residents in June, with a nationwide rollout to follow. Pricing details are still under growth, but Teal Health is actively engaging with insurance providers to secure coverage and exploring options for subsidized costs and flexible payment plans for uninsured individuals.

FDA Approves At-Home Cervical Cancer Test
teal Health

Frequently Asked Questions (FAQ)

What is the Teal Wand?
The Teal Wand is an FDA-approved at-home device for self-collecting vaginal samples for cervical cancer screening.
How dose it work?
Users swab their vagina with the device, detach the swab, and mail it to a lab for HPV testing.
Is it as accurate as a Pap smear?
Teal health claims its solution is as accurate as in-clinic screening, based on their clinical study.
When will it be available?
Shipping begins in California in June, with a nationwide rollout planned.
how much will it cost?
Pricing is not yet available, but Teal Health is working with insurance providers and exploring options for subsidies and flexible payment plans.

Pro Tip

Consult with your healthcare provider to determine if at-home HPV testing is right for you. Discuss your individual risk factors and screening history to make an informed decision.

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