Roche announces FDA approval of HPV self-collection solution
Expanding access and screening options to help eliminate cervical cancer with one of the first HPV self-collection solutions in the US
15 May 2024
Roche has announced the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. 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.
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.
“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.”
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.