FDA Approves First Home Test for Cervical Cancer Screening

Pap smears are an important tool for preventing cervical cancer because they can detect cellular abnormalities before cancer is diagnosed. Unfortunately, a system barrier or lack of comfort with the program means that many people don’t receive it. But on Friday, the FDA approved the first home test for screening for cervical cancer, a less invasive and possibly easier to use cervical smear.
The newly approved test was developed by San Francisco-based startup Teal Health. Like a traditional pap smear, a cyan health test for human papillomavirus or HPV can cause almost all cervical cancer. However, this is a test, the turquoise wand only requires a vaginal swab with a sponge-like tool, rather than inserting a mirror to scratch cells from the cervix.
Kara Egan, CEO and co-founder of Teal Health, said in a statement that the approval was not “just an innovative product—which ultimately provides women with a meaningful choice to live—to do it quickly and comfortably from home.”
“Because when we make care more accessible, we help women stay healthy, stay healthy for themselves and those who rely on them every day,” Egan continued.
In the United States, about 11,500 new cases of cervical cancer are diagnosed each year, and 4,000 people will die. However, cervical cancer may be “errorization”[d] Throughout our lives, Dr. Alexi Wright, director of gynecological oncology outcomes research at the Dana-Farber Cancer Institute, told the New York Times: “We have the tools to do this. We just don’t have a comprehensive HPV vaccination or cervical cancer screening and we usually don’t have access to those at the highest risk. ”
According to the American Cancer Society, cervical cancer deaths have dropped by more than half since the mid-1970s, although it has recently escalated. A 2022 study found that 23% of people were on screenings in 2019, compared with 14% in 2005. Despite the different reasons, one study found that lack of insurance and cost are common factors. In addition, cervical cancer rates in rural areas are 25% higher and mortality rates are 42%, which may be due to a lack of resources and healthcare providers. Discomfort is also a big obstacle for some people. In 2023, many participants in Michigan Medical Research said that the at-home kit “provides a comfortable, convenient and flexible option without trauma.”
At home screening is an effective alternative to closing the screening gap. One study found that mailing kits to people screening for cervical cancer increased by 50% compared to providing only routine care. Furthermore, they are as accurate as clinical testing. (Teal Health also conducted a self-study study.)
Starting in California, the Tsuki Health Plan will offer a kit next month. The company also coordinates with major insurance providers to pay for the fees. In addition to testing through Teal Health’s platform requirements, people can coordinate follow-up care when necessary.