A San Francisco-based startup received FDA approval Friday for the first time at home cervical cancer test.
The company, called Teal Health, was founded in 2020 and has raised $23 million. The startup has developed an at-home cervical cancer screening kit designed to provide patients with alternative pap smears in the office.
Many women do not receive pap smears, the standard screening method for cervical cancer – CDC guidelines say women aged 21-65 should be tested regularly, but only one in four women of screening age are screened. Not only do many women work hard to find this exam, but many patients find PAP uncomfortable and invasive.
Tsubasa is solving this problem by providing patients with their own cervical cancer screening to solve their own homes.
Once users request Teal’s Home Collection Kit, their orders are reviewed to ensure eligibility. They have since had a brief visit with the Tsubasa provider, who opened a kit for them and explained the process of collecting at home. The kit is then delivered to the patient’s home.
Then, using a cyan screening device called a cyan wand, then self-collect the cervical sample, sealing the sample and sending it to the lab. Once the sample is processed by the lab, the cyan clinician reviews the results and then shares them with the patient through its secure cyan account.
If patients get positive results, they can almost contact the turquoise provider to discuss the next step – if additional follow-up care is required, referrals can be coordinated on the turquoise platform.
“In the current standard of care, 75% of women do not take the next steps required. We believe that this ability can really explain to someone what their outcome is and what their next steps are crucial to addressing the problem,” said Kara Egan, CEO and founder of Teal.
She added that the startup’s telehealth platform also ensures that providers can always answer any questions that patients may have in any part of the process.
Now that the Tsubasa test has been approved by the FDA, the startup is starting to work on commercializing its products.
“We’ve been waiting for it to pass the FDA. We believe the FDA is very important because you do need to do clinical trials to show that it’s just as accurate as it is. [as a pap smear]. This is important to women. We don’t want something that’s not that good. We want something good, but it’s more convenient and comfortable. ” Egan explained.
She said the Tsubasa program acquires customers through direct marketing – it will also build partnerships to help a wider audience through trust channels such as providers, employers and payers.
The startup is preparing to launch first in California and has entered the network with Aetna, Cigna, UnitedHealthCare and Anthem Blue Cross Blue Shield networks.
“We also have conversations with several large national payers to get coverage nationwide. For us, the goal is to make sure it is affordable for women,” she declared.
She said the Tsubasa plans to start shipping tests to patients’ homes sometime next month.
Photo: Nicole Morrison
