Dive Brief:
- Teal Health published data Monday from a trial of its cervical cancer screening sample self-collection device in JAMA Network Open.
- The paper describes a trial of 599 people who both self-collected samples and underwent standard clinician collection. Self-collection correctly identified 95.2% of the positive samples.
- Teal won Food and Drug Administration approval for the self-collection device in early May, setting the company up to start shipping the product to customers in June.
Dive Insight:
The Teal Wand device allows people to self-collect samples for cervical cancer screening at home, rather than undergoing collection by a clinician at a healthcare facility. Screening rates in the U.S. have fallen this century, culminating in almost one-quarter of women aged 21 to 65 years not being up-to-date with testing in 2023. A project in Sweden suggests self-collection could increase uptake of screening.
Teal won FDA approval for a self-collection device after running a study at 16 sites in the U.S. Writing in the JAMA paper, researchers said the study was sized to obtain the number of HPV-16-positive samples requested by the FDA.
HPV-16 is strongly associated with cancer. The trial found self-collection identified 95.8% of samples that tested positive for HPV-16 and HPV-18, another cancer-causing virus, in the clinician-collected process. Absolute clinical sensitivity for the detection of high-grade cervical dysplasia, a condition in which abnormal cells are in the cervix, was equivalent for self-collected and clinician-collected samples.
The self-collection device was linked to two adverse events. One patient had a minor cervical abrasion without associated bleeding or pain. Another patient reported spotting after collection. No spotting was noted on the clinician examination.
More than 92% of patients said the instructions were easy or very easy to understand. Assuming the test results are comparable, 93% of patients said they would choose self-collection over traditional clinician-collection.
Teal plans to start shipping the device to customers in California next month before expanding across the U.S. The company raised $10 million in January and is partnered with Labcorp. Samples collected with the Teal Wand are analyzed using Roche’s Cobas HPV test.
