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).
The startup company’s test, Teal Wand, detects human papillomavirus (HPV), which is responsible for nearly all cervical cancers, similar to Roche’s cobas HPV test. But Teal Wand allows women to collect samples from home and send it to a certified lab for testing, while Roche’s test is approved for use in the clinic.
Teal Health did not disclose the test’s price, but said it was working with major insurance providers for coverage and flexible payment options.
Egan pointed to another at-home test called Cologuard, made by Exact Sciences, to detect colon cancer.
“Cologuard [is] fully covered by most insurance, but also, if you have to pay out pocket, it’s around $600. We plan to be less than that,” she told Reuters.
Teal Health plans to begin rolling out the kits in June for patients aged 25 to 65.
