Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible

Recently expanded laboratory tests to screen for human papillomavirus (HPV) could mean far more women are tested for the disease on a regular basis, potentially finding cervical cancers earlier and reducing mortality from the disease.

Reducing mortality from cervical cancer in the US has mostly been a success story. It has declined by 40 percent since the early 1990s. It stood at 3.5 deaths per 100,000 patients in 1992, but only 2.1 per 100,000 died as of 2022.¹ Experts credit the decline to more screenings and the use of an HPV vaccine.

HPV screening challenges

However, the mortality rate remains higher for poor women and women of color, likely due to issues surrounding access to regular healthcare services. And there is also another issue that has emerged in recent years: A significant increase in the number of women who have not had cervical cancer screenings at recommended intervals.

According to the National Cancer Institute, 23 percent of women in the US were overdue for screenings in 2019. That compares to just 14 percent in 2005.²

One of the issues is anxiety over the Pap smear procedure, which is invasive and can cause significant pain in some patients. “This exam can provoke negative physical and emotional symptoms such as pain, discomfort, anxiety, fear, embarrassment, and irritability,” stated a 2021 study in the Journal of Primary Care & Community Health. “These negative symptoms can interfere with preventative health screening compliance resulting in delayed or avoided care and significant health consequences.”³

Potential solutions

However, self-collection options may help reduce such screening challenges. The U.S. Food and Drug Administration (FDA) recently expanded the accessibility of two tests, allowing patients to self-collect the cell samples required for HPV testing. The tests include the Onclarity^™ HPV Assay by Becton, Dickinson and Company (BD) and Roche’s cobas^® HPV Test. The FDA approvals allow women to collect the sample in a clinical setting. A third option, the Teal Wand^™ sample collection device, is aiming for an approval that would allow specimen collection to occur from home.

BD noted in a statement that its Onclarity assay can be used in non-traditional settings, such as pharmacies or mobile clinics.⁴

“Many patients are uncomfortable with the intimate nature of a pelvic exam,” said Jeff Andrews, MD, a gynecologist by training and BD’s vice president of global medical affairs for diagnostic solutions, in the statement. “Also, many people live in areas without a local doctor or clinician trained to obtain a sample with a speculum. The option to self-collect in a healthcare setting can help women overcome some of these barriers.”⁴

Christine Snyder, BD’s vice president of global marketing, said that the expanded tests recently began to ship, and that the initial response has been enthusiastic.

“Many customers have already ordered validation kits and product to begin the process of getting up and running,” Snyder said in an email, adding that the first self-collected tests should begin soon. “We expect to have a large network of labs accepting these patient-collected samples in the coming year.”

Roche, which is based in Basel, Switzerland, suggested that the approval for self-collection could be used on a global scale to reduce cervical cancer rates.

“With vaccinations, innovative diagnostic tools, and screening programs, achieving the World Health Organization’s goal of eliminating cervical cancer by 2030 is within reach,” said Roche Diagnostics chief executive officer Matt Sause in a statement about the FDA approval. “Our HPV self-collection solution helps support this goal.”⁵

Teal Health’s Teal Wand may take that a step further. In May, the San Francisco-based startup received Breakthrough Device Designation from the FDA for the device, which, if eventually approved, could allow women to collect specimens for screening from their own home. According to a 215-patient study undertaken to obtain the breakthrough designation, 97 percent of participants said the device was easy or very easy to use, while 94 percent said they would choose a self-collection option over a clinician performing the collection. Moreover, 87 percent said they would be more likely to get screened for cervical cancer if the Teal Wand was an option. A follow-up study was launched late last year with 600 participants, the company said.⁶

A Teal spokesperson added that the data from the larger study was being gathered with the intent of submitting it to the FDA this fall as part of a De Novo submission. The data will be published publicly in late October.

If the De Novo submission is successful, Teal Health would be one step closer to its vision for the future, described in six succinct words on its homepage: “No more stirrups, no more speculum.”

References:

1. https://seer.cancer.gov/statfacts/html/cervix.html
2. https://www.cancer.gov/news-events/cancer-currents-blog/2022/overdue-cervical-cancer-screening-increasing
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970676/
4. https://www.prnewswire.com/news-releases/women-in-us-can-now-collect-their-own-sample-for-cervical-cancer-screening-302145620.html
5. https://www.roche.com/media/releases/med-cor-2024-05-15
6. https://www.getteal.com/news/teal-health-completes-clinical-trial-at-record-speed-and-receives-fda-breakthrough-designation-for-its-at-home-cervical-cancer-screening-device-the-teal-wandtm

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Key recent FDA approvals of laboratory-related platforms, IVD devices, and over-the-counter tests and products include: