Roche’s human papillomavirus (HPV) self-collection solution has been approved by the US Food and Drug Administration (FDA), offering individuals an alternative to clinician collection procedures.
More than 13,000 people are diagnosed with cervical cancer every year in the US, with specific types of HPV accounting for more than 95% of all cases.
Screening for HPV can help identify those who are at risk of developing cervical cancer so that the disease can be found and treated before it is able to develop.
Despite this, more than half the patients diagnosed with cervical cancer in the US have never been screened or have only been screened infrequently for HPV.
There are many factors that contribute to individuals not participating in screening programmes, including access to healthcare, social and economic barriers, a history of traumatic experiences, cultural concerns and embarrassment.
Roche hopes that its self-collection solution will help reduce these barriers by providing an alternative option to more invasive clinician collection procedures while also ensuring “accurate and reliable results”.
Individuals will be able to collect their own vaginal samples in a healthcare setting. These will then be sent to a laboratory for analysis with Roche’s cobas molecular instrument and those who receive a positive HPV result will continue their care with a healthcare provider.
The approval falls in line with the World Health Organization’s (WHO) global strategy to eliminate cervical cancer, adopted in August 2020.
Specifically, these targets include fully vaccinating 90% of girls with the HPV vaccine by age 15, screening 70% of women using a high-performance test by age 35, and again by age 45, as well as ensuring 90% of women identified with cervical disease receive treatment.
Commenting on the authorisation, Matt Sause, chief executive officer of Roche Diagnostics, said: “With vaccinations, innovative diagnostic tools and screening programmes, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach.
“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.”