The US Food and Drug Administration (FDA) has approved the first at-home test for cervical cancer screening, its maker Teal Health said on Friday, offering an alternative to smear tests that need to be undertaken at a doctor’s office.
Pap smear tests have significantly reduced cancer incidence from when they were first introduced 80 years ago. But they can be uncomfortable and inconvenient owing to the requirement for an in-clinic exam.
Teal Health said the FDA’s decision was based on a study in more than 600 women that showed self-collected samples using its test had the same performance as clinician-collected samples.
The approval is “not just about an innovative new product, it’s about finally giving women an option that makes sense for their lives, something that can be done quickly and comfortably at home”, said Teal’s co-founder and chief executive, Kara Egan.
Each year in the US, about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die of the disease, according to the Centers for Disease Control and Prevention (CDC).