Roche announces FDA approval of one of the first HPV self-collection solutions in the U.S.

May 20, 2024
Each year in the U.S., more than 13,000 patients are diagnosed with cervical cancer.

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.

Roche release on Globe Newswire