Roche’s HPV self-collection screening option approved by FDA

Roche has announced that the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-collection solution.
This approval makes the solution one of the first available in the US, allowing more women to utilise an accessible screening option. The new testing option requires women to collect their own vaginal samples in a healthcare setting, which is then sent to a laborator y for analysis.
Roche has undertaken collaborations with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), on its Cervical Cancer ‘Last Mile’ initiative, which has contributed to the regulatory approva l of this novel screening option.
Currently, more than 50% of patients in the US who are diagnosed with cervical cancer have never been screened or have only had infrequent screening and do not participate in routine screening, t herefore innovations making screening more accessible are a step in the right direction.
Matt Sause, chief executive officer of Roche Diagnostics, commented: “With vaccinations, innovative diagnostic tools and screening programmes, achieving the World Health Organization’s (WHO) 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.”