America’s First At-home Cervical Cancer Screening Device Approved by FDA

Roughly 4,000 women die from cervical cancer annually in the United States, according to the CDC.

Published: 5/10/2025, 7:57:25 PM EDT

America’s First At-home Cervical Cancer Screening Device Approved by FDA — Signage outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)

Women’s health company Teal Health received approval from the Food and Drug Administration (FDA) for its cancer detection tool Teal Wand, “the first and only at-home vaginal sample self-collection device for cervical cancer screening in the United States,” the company said in a May 9 statement.

When a woman has cervical cancer, the cells in the cervix, which connects the vagina to the upper part of the uterus, start to grow uncontrolled. The main cause of these cancers is infections from the human papillomavirus (HPV), a virus pathogen passed between people through sexual contact. The cancer typically occurs among women aged over 30.

Cervical cancer screenings are “critical to a woman’s health, but they are inconvenient and uncomfortable for most. Now women have a new way to screen that is as accurate as going to the doctor’s office, comfortable, and done from home,” the company said.

Teal Wand is a prescription device that will soon be made available online at the company website for individuals aged 25 to 65.

Women can use the company’s telehealth service to consult with Teal medical providers who prescribe the kit, which is then shipped to the home address.

Once a person receives the kit, they collect a vaginal sample and send it to the company. A certified lab will process the sample and provide the results.

“Cervical cancer is one of the only cancers that is almost entirely preventable with regular screening, yet more than 1 in 4 women in the U.S. are behind,” according to the company.

“With the Teal Wand, women are testing a sample for HPV (human papillomavirus), the virus that causes nearly all cervical cancers, using the same highly accurate HPV test that medical guidelines recommend and providers use in the clinic.”

The FDA approval of Teal Wand is supported by a company study that showed self-collected samples using the service “have the same performance as clinician-collected samples,” detecting cervical precancers 96 percent of the time, said Teal Health.

Cervical precancers refer to abnormal cervical cells that are not yet cancerous but could be an indicator of cancer developing later.

The company intends to make its Teal Wand kits available beginning next month, first in California and later across the United States. Flexible payment options via partnering with insurance companies are also being explored.

The FDA confirmed the approval in an email to The Epoch Times.

Testing for Cancer

According to data from the Centers for Disease Control and Prevention, roughly 11,500 new cervical cancer cases are diagnosed annually in the United States, with around 4,000 women dying from the disease.

As of 2021, the southern regions of the United States had higher rates of cervical cancers per 100,000 women. This includes states such as Texas, Oklahoma, Arkansas, Louisiana, Florida, and Alabama.

There are two screening tests conducted for cervical cancer—HPV and Pap. An HPV test looks for the HPV virus that can trigger cell alterations in the cervix, A Pap test looks for precancers.

In a Dec. 10 statement, the U.S. Preventive Services Task Force had recommended that clinicians screen women between the ages of 21 and 29 with a Pap test every three years.

For women between the ages of 30 and 65, it recommended screening with an HPV test once every five years.

“New evidence shows that screening with an HPV test every 5 years provides the best balance of benefits and harms for women ages 30 to 65, meaning it helps detect the early signs of cervical cancer with fewer harms, like unnecessary follow up tests and procedures,” said the statement.

“However, all three screening methods—HPV tests, Pap tests, and co-testing—are effective and recommended by the Task Force. Current evidence continues to show that getting a Pap test every 3 years is the best screening approach for women ages 21 to 29.”

From The Epoch Times