Avnesh Thakor's Teal Health Wins FDA Approval As First Home Cervical Cancer Test Kit
By Reuters | 09 May, 2025

The Teal Wand allows women to take pap smears at home and send it in for testing for the HPV virus, the key marker for cervical cancer.

The U.S. Food and Drug Administration has approved the first at-home test for cervical cancer screening, its maker Teal Health said on Friday, offering an alternative to Pap smears that need to be undertaken at a doctor's office.

Pap smear tests have significantly reduced cancer incidence from when they were first introduced 80 years ago. But they can be uncomfortable due to the requirement for an in-clinic exam.

Each year in the U.S., about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die of this, according to the Centers for Disease Control and Prevention.

Teal Health said the FDA's decision was based on a study in more than 600 women that showed self-collected samples using its test had the same performance as clinician-collected samples.

The approval is "not just about an innovative new product, it's about finally giving women an option that makes sense for their lives — something that can be done quickly and comfortably at home," said Teal's co-founder and CEO Kara Egan.

Its device, Teal Wand, detects human papillomavirus (HPV) — the virus responsible for nearly all cervical cancers.

The Teal Wand, similar to Roche's cobas HPV test, allows women to collect samples from home and send it to a certified lab for testing. Roche's test, however, is approved for use in the clinic.

Teal Health plans to begin rolling out the kits in June, starting with California. The device will be available at the startup's telehealth platform for patients aged 25 to 65 years.

The company did not disclose the test's price. It said it was working with major insurance providers and plans to have flexible payment options.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Manas Mishra and Shilpi Majumdar)