The Food and Drug Administration (FDA) has recently approved the first at-home screening tool specifically designed to detect cervical cancer, providing an innovative alternative to the traditional Pap smear typically performed in a doctor's office. This new tool, developed by Teal Health, empowers patients to self-collect a vaginal sample and send it to a laboratory for comprehensive testing.
The at-home screening wand allows users to collect samples conveniently from the comfort of their own homes. The samples are then analyzed for high-risk strains of human papillomavirus (HPV), a sexually transmitted infection that is responsible for nearly all cases of cervical cancer. According to data from the Centers for Disease Control and Prevention (CDC), approximately 11,500 new cases of cervical cancer are diagnosed each year in the United States, leading to around 4,000 deaths annually.
Experts emphasize that due to the effectiveness of screening tools and the availability of the HPV vaccine, cervical cancer is considered one of the most preventable types of cancer. Emily Ko, an associate professor of gynecologic oncology at the Perelman School of Medicine at the University of Pennsylvania, notes, “There is still a large proportion of women who could be screened for cervical cancer but are not getting screened because of various reasons. Being able to extend this to home screening will help fill that gap.”
Many may wonder if the at-home test offers the same reliability as traditional screenings conducted in a doctor's office. The answer is yes; while the method for collecting the sample differs, the at-home wand utilizes the same FDA-approved HPV tests recommended by the American Cancer Society and the U.S. Preventive Services Task Force. This ensures that the at-home screening provides the same level of clinical accuracy as tests performed in medical facilities.
By allowing patients to collect samples at home, this innovative tool can eliminate several barriers that prevent individuals from accessing necessary screenings. Colleen Denny, an associate professor in the obstetrics and gynecology department and director of family planning at NYU Langone Hospital in Brooklyn, states, “We know that access to a facility can be a big barrier for people. It may be more comfortable for people with a history of trauma or gender dysphoria to screen themselves.”
The at-home testing process begins with a virtual consultation where a healthcare professional reviews the individual’s health history and assesses eligibility. If approved, a testing kit is shipped to the patient’s home. After collecting the sample, it is returned to the lab for testing. Teal Health providers then analyze the results, and if any follow-up care is necessary, referrals will be provided. The test is approved for individuals aged 25 to 65 with a cervix.
While the at-home cervical cancer screening tool aims to enhance access, some reproductive-health experts have raised concerns about potential false positives. Denny points out that although most people will contract HPV at some point in their lives, it often resolves on its own. However, a positive result necessitates proper follow-up. “A positive test doesn’t mean you have cancer, but it does mean you need more screening and support to navigate that,” Denny explains.
As for the cost, Teal Health has not publicly announced a cash price for its at-home cervical screening test. However, the company is actively working with insurers to ensure affordability. Currently, Teal Health is in-network with most major insurers in California and is looking to expand its coverage nationally. Once launched, payment options will include insurance coverage, out-of-pocket payments, and reimbursement through health savings accounts (HSA) and flexible spending accounts (FSA).
Kara Egan, the CEO and co-founder of Teal Health, expresses hope that this device will help bridge the gap in women’s healthcare, particularly for individuals who may struggle to access traditional gynecologic care. The introduction of this at-home cervical cancer screening tool marks a significant advancement in making essential health services more accessible to all.
