FDA Approves First At-Home Cervical Cancer Screening Device

The FDA recently approved Teal Wand, the first at-home, vaginal, self-collection device for cervical cancer screening, according to a news release. The kit, made by Teal Health, will be available next month, starting in California. Teal is currently working with insurance companies to develop coverage options and payment assistance plans, the news release says. 

Patients can order a Teal Wand kit through the Teal website. A virtual appointment will be scheduled with a Teal healthcare provider who prescribes the kit and sends it. Once the patient receives the kit and gathers their sample, they send it to a lab where it is tested for HPV. Results are available online in the patients' Teal account.

This approval was made using results from the SELF-CERV study of more than 600 women, which showed that the Teal Wand detected precancerous cells 96% of the time, which is the same as a clinician’s collection, the study says. Almost all (94%) of women in the study reported that they preferred Teal Wand self-collection over in-person collection by a clinician.

Access is at the center of Teal’s research priorities, according to Rahma S. Mkuu, Ph.D., M.P.H., assistant professor in the Department of Health Outcomes & Biomedical Informatics at the University of Florida College of Medicine. Mkuu is currently researching ways to improve access to the Teal Wand and to figure out ways to boost women’s confidence while using it. She sat down with Managed Healthcare Executive to explain the significance of this FDA approval.

Rahma S. Mkuu, Ph.D., M.P.H.

This Q&A has been edited for length and clarity.

MHE: Why is cervical cancer a public health problem?

Mkuu: Currently, about 4,000 women every year die from cervical cancer, but these deaths could be prevented through screening. Ninety-nine percent of cervical cancers diagnosed are because of the human papillomavirus (HPV). If a woman is positive for HPV, it doesn't mean that she’ll develop cervical cancer. What it means is that we need to do close surveillance monitoring. Providers might recommend a Pap smear after a positive test to ensure that there are no abnormal cells. In fact, [providers] can catch cervical abnormalities three to seven years before they turn into cancer.

In cancers among women, cervical cancer used to be the leading cause of death in the United States. Then, cervical cancer screening, specifically Pap smears, which test cervical abnormalities, became more widely available, and we have more than halved the deaths of women diagnosed with cervical cancer.

MHE: Which populations are the most at risk for cervical cancer?

Mkuu: Cervical cancer mainly affects women who have never been screened, and these are typically women who have very limited access to care, whether it's lack of insurance, proximity to a provider or financial. It could also be a time barrier. For example, I'm a mom of a toddler, so it's very difficult to find time to prioritize my own health.

Exam fear is also a barrier. The Pap smear is infamous. The process of getting those cervical cells is very uncomfortable.

MHE: Why is the FDA approval of the Teal Wand significant?

Mkuu: Cervical cancer tests like the Teal Wand test allow women to take their health into their own hands by giving a woman the opportunity to self-swab.

The reason it got FDA approval is because self-samples are as accurate as a provider's sampling. This is a really big change in addressing a lot of barriers that women face in getting cervical cancer screening.

MHE: You’re currently researching ways to improve test access and confidence while using the test. Can you tell me more about that?

Mkuu: In my current research, I'm focused on how to improve cervical cancer screening, specifically for rural women, women living in poverty and women who have chronic conditions. These women face extra barriers to cervical cancer screening.

One way that we are solving this problem is by asking women how we can improve their self-collection experience. Research already shows us that women prefer self-collection over in-person screenings with their providers. However, few studies highlight what some women have shared with us - that they are concerned about whether they did the test correctly.

In our focus groups with women, they gave us feedback on how we could improve tests. For example, making sure the instructions are easier to read and even making sure that within the materials, there's representation of women across age groups.