Food and medication administration approved on Friday the first test at the home for the detection of cervical cancer, developed by the Startup Teal Health, based in San Francisco.
The company began to develop the prototype for its bluish green wand just over five years ago. The concept was to make cervical cancer detection more accessible through the Telesalud and a test that could be self -administered at home, instead of in a doctor's office.
“The pandemic showed everyone that the Telesalud is something that is preferred … and facilitated attention to most Americans,” said Kara Egan, CEO of Teal Health, and added that Covid also demonstrated “the evidence at home were something that people could handle and really understand.”
The bluish green wand works very similar to a buffer applicator, with a large swab that the user can insert to collect a sample for the tests. The FDA designated the tool as an innovative device after the results of the company's clinical trials showed that the accuracy of the self -administered test was comparable with a detection in the office carried out by a clinician, with a 96%precision rate.
Teal plans to make the wand available in California first, starting in June.
The company has had conversations with carriers about the insurance coverage for the test as a preventive exam, which for most women would be covered without copagos as an annual doctor's visit.
The American Cancer Society recommends that women receive a cervical cancer exam every three years from the age of 21.
However, Egan says that 1 in 4 women are delayed in detection, partly because they cannot find time for a gynecologist in person, a problem especially for women in rural areas that often have to travel beyond their community to reach a doctor.
“It's about increasing access to attention and making sure we have more options to obtain that attention,” he said.
Before its anticipated approval of the FDA, Teal Health raised $ 10 million in its last financing round in January to help increase production for the launch of the blue green green wand. The investment was directed by Forerunner Ventures and Emerson Collective de Laurene Powell Jobs. The company has raised a total of $ 23 million in investors, such as Serena Ventures de Serena Williams, as well as LabCorp firm proof.
The company's milestone occurs as investors have been more interested in women's health technology.
Last year, there was an influx of $ 680 million in the space invested in 30 agreements, according to Deloitte data. About 60% of these funds were for investments at the posterior stage, according to Jen Radin, Director of Deloitte's Life Sciences and the practice of medical care.
“From 2023 to 2024 Femtech saw a growth of 41%, exceeding general health technology, which grew only 10%,” said Radin.
Femhealth Ventures's managing partner, Manheesha Ghiya, says that while investors are now more cautious, in general, interest in women's health technology is moving beyond motherhood and menopause.
“Many more people think about the healthiest women's health and support this type of innovations, and that includes the great players established as Medtech, Pharma, Biotech, large public companies that think more widely about women's health,” Ghiya said.
