FDA Approves First At-Home Cervical Cancer Screening Kit

Story BySaloni Tyagi

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FDA Approves First At-Home Cervical Cancer Screening Kit — Source: X

In a company-led study involving over 600 participants, self-collected samples matched the accuracy of clinician-administered ones.

The US Food and Drug Administration (FDA) has approved the first-ever at-home cervical cancer screening kit that allows women to collect their samples, marking a development in preventive healthcare.

Developed by Teal Health, the screening tool called the Teal Wand uses a swab to collect samples without requiring a speculum.

The vaginal samples are then tested in a lab to detect HPV (human papillomavirus), the leading cause of cervical cancer.

In a company-led study involving over 600 participants, self-collected samples matched the accuracy of clinician-administered ones.

“Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward. It offers an evidence-based way to expand access without compromising accuracy,” said Christine Conageski, principal investigator of the trial and director of the Complex Dysplasia Clinic at the University of Colorado.

Traditionally, such screenings have required a visit to a clinic or physician’s office for a Pap smear or HPV test.

A federal health panel last year endorsed self-collected HPV testing as a means to increase participation in cervical cancer screening programs.

HPV is one of the most prevalent sexually transmitted infections. While most HPV infections resolve on their own, persistent infections can progress to cervical cancer, particularly in women who remain unscreened, underdiagnosed, or untreated.

The test kit is available for average-risk women aged 25 to 65 by prescription, and can be obtained via Teal Health’s network of online health providers.

Sales will begin in June in California through Teal Health’s website and telehealth platform, where licensed providers will handle prescriptions, review test results, and offer follow-up care guidance.

India’s Fight Against Cervical Cancer

Recently, Union Minister Dr Jitendra Singh chaired a high-level review meeting in the capital with key government and private stakeholders to assess the status and performance of indigenously developed HPV test kits for cervical cancer screening.

Additionally, in a significant breakthrough for cancer care, researchers at AIIMS Delhi developed a new blood test designed to monitor whether cervical cancer treatment is effective or if the disease has returned.

The test uses droplet digital polymerase chain reaction (ddPCR) technology.

Moreover, it detects fragments of human papillomavirus (HPV) DNA in the bloodstream. These fragments are strong indicators of tumour size and response to treatment.