The FDA approves the first cervical cancer test at home

On Friday, a startup based in San Francisco received approval from the FDA for the very first test of cervical cancer at home.

The company, named Teal Health, was founded in 2020 and raised $ 23 million. The startup has developed a cervical cancer screening kit at home, which seeks to give patients an alternative to the desktop jacket.

Many women do not receive PAP smear, which is the standard screening method for cervical cancer – CDC guidelines say that women should be tested regularly under 21 to 65, but only 1 in 4 women in screening age is detected. Not only do many women find it difficult to find access to this exam, but many patients find the PAP uncomfortable and invasive.

Teal addresses this problem by giving patients the possibility of administering their own detection of cervical cancer in the comfort of their own house.

Once a user has requested a Teal home collection kit, his order is examined to guarantee eligibility. After that, they have a short visit with a Turchas supplier, who prescribed the kit for them and explains the house collection process. Then Teal sends a kit to the patient’s home.

Using the Teal screening device, called the Sarcelle wand, the patient can then auto -ch a cervical sample, seals the sample and send it to the laboratory. Once the laboratory was treated, Teal clinicians examine the results, which are then shared with the patient via their secure Sarcelle account.

If a patient receives a positive result, he can practically connect to a Sarcelle supplier to discuss the next steps – and if additional follow -up care is necessary, he can coordinate the reference on the TEAL platform.

“Screening is as successful as monitoring and sorting. In the current standard of care, 75% of women do not take the required monitoring stages. We believe that this ability to really explain to someone what their results are and what their next steps are extremely important to solve this problem, “said Kara Egan, CEO and founder of Teal.

The Startup’s TV platform also guarantees that suppliers are always available to answer any questions that patients can have throughout any part of this process, she added.

Now that the Teal test has received approval from the FDA, the startup is working on the marketing of the product.

“We were waiting for him to go through the FDA. We believe that the FDA is incredibly important because you must really do a clinical trial to show that it is just as precise [as a pap smear]. This is important for women. We don’t want something that is not so good. We want something so good, but more practical and comfortable, “said Egan.

Teal plans to acquire customers through direct marketing-and he will also pursue partnerships to help reach a wider audience through trusted channels such as service providers, employers and payers, she said.

The startup is first preparing to launch in California, and she is already on a network with Aetna, Cigna, Unitedhealthcare and Anthem Blue Cross Blue Shield, said Egan.

“We are also in conversations with several large national payers so that it covered nationally. For us, the goal is to make sure it is affordable for women, “she said.

She said Teal plans to start sending tests to patient home next month.

Photo: Nicole Morrison