USFDA approves Roche HPV self-collection solution in US

HPV self-collection offers an accessible screening option. In a healthcare setting, an individual collects their own vaginal sample, which is sent to a laboratory for analysis with Roche’s cobas molecular instrument. Those who receive a positive HPV result would then continue their care with a healthcare provider.

“With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, CEO of Roche Diagnostics. “Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing.”

More than half the patients diagnosed with cervical cancer in the U.S. have never been screened or have only been screened infrequently, and they do not participate in routine screening. Many factors can contribute to individuals not participating in cervical cancer screening programs, such as access to healthcare, social and economic barriers, history of traumatic experience, cultural concerns and embarrassment. Roche’s self-collection solution can help reduce these barriers by offering an alternative to clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions.

Roche has collaborated with the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), on the Cervical Cancer “Last Mile” Initiative. This public-private partnership has, in part, facilitated the regulatory pathway towards the approval.