At-home cervical cancer screening device demonstrates comparable performance to clinic-based testing in major US trial

A self-collection device for cervical cancer screening has shown equivalent effectiveness to traditional clinic-based testing, according to new research that could help address screening gaps affecting women’s health outcomes.

The SELF-CERV trial, which validated the Teal Wand device across 16 medical sites in the United States, found that self-collected samples detected precancer 96 per cent of the time with comparable performance to clinician-collected samples.

The study was led by researchers at the University of Colorado School of Medicine.

Christine Conageski is associate professor of obstetrics and gynaecology and principal investigator for the trial.

Conageski said: “Studies have shown that half of new diagnoses of cervical cancer are those that were not screened in the preceding five years.

“That tells us that cervical cancer has really become a disease of access: access to the vaccine for prevention, access to cervical cancer screening, and follow up management of the first abnormal screen.”

The US Food and Drug Administration approved the Teal Wand in early May following completion of the trial, which involved more than 600 participants who received mailed kits with instructions for easy sample collection and return to laboratories.

Researchers estimate that a quarter of women are not up to date on their cervical cancer screening, commonly known as a pap smear.

Current US guidelines recommend screening every three years for women aged 21 to 29 years and every five years for women aged 30 to 65 years.

Conageski, who is also a physician at the CU Cancer Center, said: “We’ve not seen the number of cervical cancer cases in the US budge in the better part of five years, and it’s because screenings are not reaching those who are at greatest risk.”

The trial revealed significant barriers to clinic-based testing, with 32 per cent of participants reporting delays due to time constraints, 32 per cent citing discomfort with examinations, and 32 per cent noting financial issues as reasons for delay.

The at-home device appeared to address many of these concerns, with 86 per cent of participants saying they would be more likely to stay up to date with screening if they could complete it at home. Over 90 per cent said they preferred the self-collection method.

 Conageski said: “With the Teal Wand, it took 90 per cent of patients less than five minutes to complete the sample collection and 60 per cent of patients less than two minutes, so it’s a quick and easy process.

“You can fit this into your schedule, whenever that may be, and avoid having to schedule an appointment,”

Cervical cancer is typically linked to certain types of human papillomavirus (HPV), which is transmitted through sexual contact.

“While many people are infected with HPV, only a small percentage develop cervical cancer, making early screening crucial for detection and intervention.

Conageski said: “If we can make screening more accessible to those that we’re not currently reaching, that is ultimately going to drive cervical cancer rates down, because cervical cancer is an almost 100 per cent preventable cancer,”

The researchers suggest that widespread implementation could benefit both patients and healthcare systems, allowing physicians to focus on other aspects of patient care during visits whilst maintaining confidence in screening reliability.