FDA approves Roche’s self-collected HPV tests

On Wednesday, May 15, 2023, Roche announced that the United States FDA has approved the company’s human papillomavirus (HPV) self-collection solution, making it the first HPV self-collection test approved in the US. The company claims that this approval and future availability of this solution will help expand access to HPV screenings and may contribute to earlier detection of cervical cancer.

According to the CDC, HPV is the most common sexually transmitted infection (STI), with roughly 43 million infections detected in 2018. The public health organization notes that HPV is common among sexually active individuals in their late teens and early 20s.

The virus is spread through vaginal, anal, or oral sex and can be spread even if a patient is asymptomatic.

While the virus resolves on its own within two years in approximately 90% of cases, when it persists, it can cause significant healthcare concerns. For example, it can cause genital warts in many cases. Beyond that, HPV infections have been linked to multiple kinds of cancer, most notably cervical cancer. However, the condition has also been associated with vulvar, vaginal, penile, anal, and oropharyngeal cancer.

The best way to protect against HPV and its associated health risks is to get the HPV vaccine, which is recommended for preteens at the age of 11 or 12 and anyone up to 26 who has not been vaccinated.

The FDA approval of Roche’s HPV self-collection solution offers a tool for detecting HPV and preventing disease spread or understanding the risk of cervical cancer.

The company’s press release notes that individuals can collect their own vaginal sample in a healthcare setting, and the sample can be sent off to a laboratory to be analyzed with Roche’s cobas molecular instrument.

“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, in the release. “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.”