The FDA has cleared for marketing the first at-home test for cervical cancer screening, according to the manufacturer. The test offers an alternative to clinician-administered Pap tests performed in-office.

Teal Health reported that the FDA’s decision was based on a study involving more than 600 women, demonstrating non-inferiority of self-collected samples compared with clinician-collected specimens.

“This 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 Kara Egan, Teal’s co-founder and chief executive officer.

The company’s test, called the Teal Wand, detects high-risk human papillomavirus (HPV), the causal agent in nearly all cervical cancer cases. Similar to Roche’s cobas HPV assay, Teal Wand enables home-based sample collection. Patients collect the sample and mail it to a certified laboratory for analysis; by contrast, Roche’s test is approved only for use with clinician-collected samples.

Teal Health has not disclosed the test’s price but stated it is pursuing insurance coverage and alternative payment models.

They expect to begin distributing the kits in June for women aged 25 to 65 years, consistent with current screening guidelines.

Source: Teal Health