FDA approves Roche HPV self-test in US

The US FDA has approved Roche’s human papillomavirus (HPV) self-testing kit, expanding screening options crucial to helping eliminate cervical cancer. 

Each year, more than 13,000 patients in the US are diagnosed with cervical cancer and approximately 4,000 die from the disease, caused by HPV infection.

Data from the Centers for Disease Control and Prevention shows that more than half of all cases of cervical cancer diagnosed in the US occur in individuals who have never been or are infrequently screened.

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.

Roche says its self-collection solution, one of the first available in the US, can help improve access to testing by allowing women the option to privately collect their own sample.

The kit, the Swiss drug maker claims, offers an alternative to more invasive clinician collection procedures, while still providing accurate and reliable results.

“With vaccinations, innovative diagnostic tools and screening programmes, 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.”

Women can use the kit in healthcare settings after they receive instructions from a healthcare professional.

The swab is then sent to a laboratory for analysis using Roche’s cobas HPV test. Those who receive a positive HPV result would then continue their care with a healthcare provider.