Patients in the US might not have to deal with the uncomfortable stirrups or the speculum often associated with cervical cancer screenings. Soon, they could take the process into their own hands, literally, by collecting their own vaginal samples from home.
The FDA has approved a device known as the Teal Wand, designed for at-home cervical cancer screening through self-collection. Teal Health, the company behind it, announced that this device received “breakthrough device” status from the FDA last year, expediting its review process.
With the Teal Wand included in Teal Health’s self-collection kit, patients will need a prescription. They will then mail their samples to a lab for HPV testing, a virus that is responsible for most cervical cancers, the company shared recently. HPV screening is essential as it helps identify women at greater risk for cervical cancer.
Traditionally, gynecologists collect samples during screenings for either HPV or cervical cytology—a test that involves examining cervical cells for signs of cancer. The HPV test looks for high-risk virus types that could lead to malignancy.
Last year, the FDA also approved similar self-collection kits for use in medical settings like doctor’s offices or urgent care facilities. At that time, Roche and Becton, Dickson and Company received FDA approval for their respective HPV tests using self-collected samples.
According to Teal Health CEO Kara Egan, the Teal Wand is significant because it’s meant for at-home use, allowing patients to avoid the hassle of in-person visits to providers.
To utilize the kit, users simply request it from Teal’s website, get a prescription, and then collect their sample in the comfort and privacy of their home before mailing it to a lab for testing with Roche’s HPV test.
The assessment results are reviewed by a clinician and communicated back to the patient. If any follow-up care is necessary, a provider will contact the patient.
Teal Health’s clinical trials indicate that using the Teal Wand produces screening results as accurate as those collected by health professionals. “It’s the same test, same accuracy, but you can comfortably do it from home,” Egan said, emphasizing the additional options this provides for women, particularly with the increasing reliance on telehealth.
Teal plans to start shipping these at-home kits in June, beginning in California before expanding their availability across the country. Those interested can sign up for a waitlist on the company’s website.
Egan mentioned that discussions are ongoing with health insurance providers regarding coverage for the self-collection kit. For uninsured individuals, pricing details will be revealed soon.
The American Cancer Society praised the FDA’s recent approval. Dr. William Dahut, the society’s chief scientific officer, highlighted that, despite the advantages of cervical cancer screenings, many eligible individuals do not undergo them regularly. This new at-home test could significantly increase screening rates, potentially reducing the incidence of cervical cancer.
According to the CDC, critical steps to lower cervical cancer risk include getting the HPV vaccine, avoiding smoking, and adhering to regular screenings. It’s estimated that roughly one in four adults are behind on cervical cancer screening recommendations.
As Dr. Ami Vaidya noted, many women avoid traditional Pap smears out of discomfort, and the new device might help those women who hesitate to seek necessary care. She believes any method that promotes regular screenings for cervical cancer is beneficial.
The US Preventive Services Task Force endorses screening for cervical cancer using Pap tests every three years for women aged 21 to 29. Women aged 30 to 65 are advised to be screened either every three years with cervical cytology alone, every five years using high-risk HPV testing alone, or a combination of both every five years.
HPV is an infection that will affect around 80% of individuals in their lifetime. It’s primarily transmitted through sexual contact and includes strains that lead to various cancers, including cervical cancer. Most HPV infections resolve on their own, but lingering infections can result in serious health issues.
Regular cervical cancer screenings are necessary since early stages often show no symptoms, while advanced cases may cause unusual vaginal bleeding or discharge. Treatment varies and can encompass surgery, chemotherapy, or radiation therapy.
