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Home » Blog » FDA Approves First At-Home Cervical Cancer Test
Health

FDA Approves First At-Home Cervical Cancer Test

Rachel CollinsBy Rachel CollinsMay 10, 2025
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On Friday, a Startup based in San Francisco received the approval of the FDA for the first Ove-Eve-EV cervical cancer test.

The company, called Teal Health, was founded in 2020 and has raised $ 23 million. The Startup has developed a cervical cancer detection kit at home, which seeks to give patients an alternative to the Papanicolaou test in the office.

Many women do not receive a Pap smear, which is the standard detection method for cervical-CDC cancer guidelines, it says that women must be regularly evaluated from the ages of 21 to 65, but only 1 in 4 women of detection age are examined. Many women not only struggle to find access to this exam, but many patients consider that Pap smear is not uncomfortable and invasive.

Teal is addressing this problem by giving patients the option to manage their own cervical cancer detection in the comfort of their own homes.

Once a user has requested a collection kit at the Teal Home, his order is reviewed to guarantee eligibility. After this, they have a brief visit with a bluish green supplier, which prescribes the kit and explains the home collection process. Then, bluish green sends a kit to the patient’s house.

Using the teal detection device, called a bluish green wand, the patient is the self -colle a cervical sample, seals the sample and sends it to the laboratory. Once the laboratory processes the sample, teal doctors check the results, which are then shared with the patient through their bluish green account.

If a patient receives a positive result, you can connect to Virtualy with a bluish green provider to discuss the next steps, and if additional monitoring care is needed, you can coordinate the reference on the teal platform.

“The detection is as successful as monitoring and triage. In the current care standard, 75% of women are not taking the required monitoring steps. We believe that this ability to explain to someone is the following Cone and that problem only,” said Kara Egan, CEO and Teal Founder.

The Startup telesalud platform also guarantees that suppliers are always notable to answer any questions that patients may have throughout any part of this process, he added.

Now that the teal test has received the FDA approach, the startup is working on product marketing.

“We have a leg waiting for Fda. We believe that the FDA is incredible important that you really need to do a clinical trial to show that it is equally precise [as a pap smear]. That is important for women. We don’t want something that is not so good. We want something so good, but more convenient and comfortable, “Egan explained.

Teal plans to acquire customers through direct marketing, and will also look for associations to help reach a broader audience through trust channels such as suppliers, employers and payers, he said.

The startup prepares to launch in California first, and is already on the network with Aetna, Cignna, UnitedHealthcare and Anghem Blue Cross Blue Shield, said Egan.

“We are also in conversations with several great national payers to obtain this national covered national. For us, the goal is to make it affordable for women,” he said.

She said Teal plans to start sending evidence to patient’s houses at some point in next month.

Photo: Nicole Morrison

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