First Of Its Kind At-Home Cervical Screening Device Gets FDA Green Light

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In a major step forward for women’s health and cancer prevention, the U.S. Food and Drug Administration (FDA) has officially approved the Teal Wand™—the first ever at-home cervical cancer screening device. Created by San Francisco-based Teal Health, the self-administered screening tool allows people to collect their own vaginal samples for testing high-risk strains of human papillomavirus (HPV), which are responsible for the majority of cervical cancer cases worldwide. This approval could mark a turning point in how we detect and prevent one of the most preventable yet deadly cancers affecting women.

A shift from speculums to self-sampling

For decades, cervical cancer screening in the United States has largely relied on the Pap smear—a clinical procedure requiring a speculum exam to collect cervical cells. Though highly effective, the process is often seen as uncomfortable, invasive, or logistically challenging. As a result, many people delay or avoid regular screenings altogether. According to the U.S. Centers for Disease Control and Prevention (CDC), nearly 25% of eligible women in the U.S. are not up to date with their cervical cancer screenings, leaving them more vulnerable to late-stage cancer diagnoses.

The Teal Wand™ offers an alternative. Roughly the size and shape of a tampon applicator, the device allows users to collect a sample themselves in less than five minutes from the privacy of their home. The sample is then mailed to a certified lab for analysis, with results shared through Teal Health’s online portal. A clinical study conducted by Teal Health found that self-collected samples using the device were 96% as accurate in detecting cervical precancer as those collected by healthcare professionals.

Why accessibility matters

This new option isn’t just about comfort—it’s about reaching the people who have historically been left behind by standard screening models. Many face barriers such as limited access to gynaecological care, distrust in the healthcare system, or simply the discomfort of a speculum exam. Others may have experienced trauma that makes pelvic exams especially difficult, or they may live in areas without nearby clinics.

An earlier study published in JAMA Network Open revealed that when given the option, a large percentage of people preferred at-home HPV testing to in-clinic visits. Teal Health’s own research backs this up. In a nationwide clinical trial involving over 600 women, 94% said they would prefer to collect their sample at home rather than book an appointment for a traditional screening.

How the Teal process works

Teal Health is pairing its at-home screening tool with a comprehensive telehealth platform. Users begin by requesting a kit online. Before receiving the kit, they complete a short virtual consultation with a Teal provider to assess eligibility and answer any questions. Once the sample is returned and analysed, users receive their results and, if necessary, a follow-up plan tailored to their health history.

Importantly, Teal Health aims to ensure that users who test positive for high-risk HPV are not left to figure out the next steps alone. If further evaluation or treatment is needed, users are connected with clinicians or local care providers to continue their care in-person. According to Teal Health CEO Kara Egan, the company’s goal is to “remove the friction” in the cervical cancer screening process—from access to follow-up.

The broader implications for cervical cancer prevention

The impact of this new tool could be far-reaching. Cervical cancer is considered one of the most preventable forms of cancer, thanks in large part to regular screening and early treatment. When caught in its early stages, the five-year survival rate is above 90%, according to the American Cancer Society. Yet in many cases, women are still being diagnosed too late, when treatment options are more limited and outcomes far worse.

Dr. Rachel Bervell, a physician and women’s health advocate, believes the approval of the Teal Wand™ represents a critical moment in addressing long-standing gaps in preventive care. “We’ve known for years that barriers to screening exist,” she said. “This is a direct response to what patients have been asking for—comfort, privacy, and autonomy.”

Equity and availability moving forward

Teal Health plans to begin distributing the Teal Wand™ in California as early as June, with a national rollout to follow. The company is currently in talks with major insurers and Medicare to ensure coverage, aiming to make the service free or affordable for most users.

According to Reuters, the FDA’s approval also includes plans for further research to assess how self-collection impacts long-term screening rates, particularly in lower-income communities. If early results are any indication, the convenience of self-testing could dramatically increase participation in preventive screenings and lower cervical cancer rates overall.

The Teal Wand™ is not the only self-collection option being explored. The World Health Organization has also been urging countries to adopt HPV self-sampling as part of its broader plan to eliminate cervical cancer as a public health problem. In fact, Australia’s national cervical screening program now includes self-collection as an option for all participants—a move that has already led to higher screening uptake among marginalised groups.

A sign of what’s to come

Teal Health’s milestone could pave the way for a new era of accessible women’s healthcare. With rising interest in at-home diagnostics and telemedicine, the Teal Wand™ fits into a broader trend of meeting people where they are—both literally and figuratively. It’s a reminder that sometimes, innovation isn’t just about the technology itself, but about the real-world barriers it helps remove.

As more people gain access to tools that allow them to care for their health on their own terms, the hope is that fewer lives will be lost to diseases we already know how to prevent. Cervical cancer doesn’t have to be deadly. The tools are there. Now, thanks to Teal Health, they might just be in your bathroom cabinet instead of a clinic 30 miles away.

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