Your next visit to the gynecologist might look different, thanks to a new alternative to traditional Pap smears.
The first shipments of self-collection HPV tests are making their way to doctors’ offices across the United States, offering a new option for cervical cancer screening.
In May, the U.S. Food and Drug Administration approved the option for patients to collect their own vaginal samples for HPV testing, a common method for detecting cervical cancer. This self-collection can be done in medical settings like doctors’ offices, urgent care centers, or pharmacies, eliminating the need for the more invasive traditional tests that use a speculum. Two companies—Roche and BD—are leading the way, with BD’s self-collection HPV tests already being shipped and Roche’s expected later this fall.
This new method is aimed at increasing accessibility and encouraging more women to get screened. Dr. Jeff Andrews, a gynecologist and vice president of Global Medical Affairs at BD, highlighted that many cases of cervical cancer occur in women who have not been screened in recent years. By offering a self-collection option, the hope is to reach under-screened populations, as has been successful in other countries like Australia and Europe.
Cervical cancer remains a significant health issue, with over 11,000 new cases diagnosed annually in the U.S., and about 4,000 deaths. The CDC estimates that half of all invasive cervical cancer cases are diagnosed in people who have never been screened, making this new testing method an important tool for early detection.
Current guidelines from the U.S. Preventive Services Task Force recommend cervical cancer screenings every three years for women aged 21 to 29 using a Pap smear. For those aged 30 to 65, the recommendation is every three to five years, depending on whether HPV testing is used alongside Pap smears. With the introduction of self-collection, the process may become more comfortable and accessible, offering an alternative for those who find traditional screenings uncomfortable.
This innovation is expected to increase screening rates and potentially reduce the incidence of cervical cancer in the U.S., especially among those who might otherwise avoid routine checkups.
Research indicates that women who perceive a Pap test as painful are significantly less likely to schedule their first exam, contributing to lower screening rates. However, reducing the discomfort associated with Pap tests could lead to greater acceptance and adherence to regular cervical cancer screenings.
Dr. John Vullo, chairman of obstetrics and gynecology at Good Samaritan University Hospital in New York, highlights the importance of making screenings more accessible. He stresses that self-screening can be a valuable option, especially for underinsured or underserved populations. Vullo supports offering this method under a provider’s supervision, ensuring patients understand both the benefits and limitations of self-screening. This approach not only provides an alternative screening option but also allows for ongoing communication with healthcare providers during routine annual exams.
For the self-collection screening, a clinician must order the test,
ensuring that patients receive appropriate follow-up and explanations of results. Once ordered, a lab prepares a kit containing instructions, a swab, and the necessary screening materials, which is sent to the doctor’s office. Patients can self-collect a sample by inserting the swab into the vagina, typically in a private setting like the office bathroom. The sample is then sent to the lab for analysis. If results are positive, further testing would be recommended by the doctor.
While self-collection is currently available only in healthcare settings, there are hopes that it will be approved for home use in the future. BD is working with the FDA to gather data for home-use approval, and Teal Health has developed the “Teal Wand,” an at-home cervical cancer screening device. The Teal Wand received “breakthrough device” status from the FDA, fast-tracking its review.
Trena Depel, vice president of clinical and regulatory at Teal Health, emphasized that self-collection could significantly benefit those who are under-screened or avoid clinician-based screenings. Regardless of the method, regular cervical cancer screening is critical, as early stages of the disease may not present symptoms. Abnormal vaginal bleeding or unusual discharge can indicate advanced cases. Treatment for cervical cancer can involve surgery, chemotherapy, or radiation.
Preventive measures, such as HPV vaccination, avoiding smoking, using condoms, and attending regular screenings, are vital. Additionally, following up with a doctor if results are abnormal is crucial in preventing cervical cancer from progressing.
