On May 15, Roche announced the U.S. Food and Drug Administration (FDA) approval of its human papillomavirus (HPV) self-collection solution—one of the first of such tests available in the United States.
Screening for HPV can help identify women who are at risk of developing cervical cancer so that the disease can be found and treated early before cervical cancer has a chance to develop. HPV self-collection offers an accessible screening option. In a health-care 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 health-care provider.
“With vaccinations, innovative diagnostic tools, and screening programs, achieving the World Health Organizations’s goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, Chief Executive Officer 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.”
Barriers to Screening
More than half the patients diagnosed with cervical cancer in the United States have never been screened or have been screened infrequently, and they do not participate in routine screening, per research conducted by the National Cancer Institute (NCI). Many factors can contribute to individuals not participating in cervical cancer screening programs, such as access to health care, 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 NCI on the Cervical Cancer ‘Last Mile’ Initiative. This public-private partnership has, in part, facilitated the regulatory pathway towards the self-collection solution’s approval.
