Roche Bags US FDA Nod for its human papillomavirus self-collection solutions

Roche reported that its human papillomavirus (HPV) self-collection solution, which was among the first available in the United States, has been approved by the US FDA. Screening for HPV can assist identify women who are at risk of getting cervical cancer, allowing the disease to be detected and treated early on.

HPV self-collection provides an accessible screening alternative. In a hospital context, a patient takes their own vaginal sample, which is then submitted to a laboratory for examination using Roche's Cobas molecular technology. Those who have a positive HPV result will continue to receive care from 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 of all cervical cancer patients in the United States have never been screened or have been screened seldom, and they do not participate in routine screenings. Many factors can contribute to people not engaging in cervical cancer screening programs, including access to healthcare, social and economic hurdles, a history of traumatic experience, cultural concerns, and embarrassment. Roche's self-collection solution can help to remove these obstacles by providing an alternative to physician collection processes, as well as accurate and trustworthy results that clinicians can use to make patient care decisions.

The pharmaceutical firm has worked with the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), on the Cervical Cancer "Last Mile" initiative. This public-private partnership has helped to pave the way for regulatory approval.