Roche announces FDA approval of one of the first HPV self-collection solutions in the U.S.
May 20, 2024
Roche announced the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States.
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.
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.
