New FDA-cleared offering expands access to evidence-based cervical cancer screening through LetsGetChecked’s end-to-end care experience
WEST CHESTER, Ohio–(BUSINESS WIRE)–LetsGetChecked powered by Fuze Health today announced it now offers the Onclarity™ HPV Self-Collection Kit, tested with the BD Onclarity™ HPV Assay, the most comprehensive FDA-cleared at-home HPV screening tool available in the U.S. today. This offering underscores LetsGetChecked’s commitment to expanding patient access to evidence-based screening solutions.
According to the National Cancer Institute (NCI), roughly one in four women in the U.S. are not up to date with cervical cancer screening, and about half of women diagnosed with cervical cancer had either never been screened or were overdue.1 At-home self-collection has the potential to help close this significant screening gap by addressing key barriers to cervical cancer screening. These include concerns about the screening experience, logistical challenges, socioeconomic factors, prior sexual trauma, and limited awareness of available screening options.2,3,4
LetsGetChecked’s expertise in at-home sample collection, design, and patient engagement was instrumental in developing a self-collection experience that is accessible, intuitive, and advances women’s health. The launch expands on LetsGetChecked’s 2023 FDA De Novo authorization—the first-ever granted for an at-home chlamydia and gonorrhea sample collection system—and reflects more than 13 years of experience delivering at-home screening programs.5
Expanding access to evidence-based cervical cancer screening advances Fuze Health’s commitment to shift women’s healthcare from reactive treatment to earlier detection and prevention. This is supported by a seamless experience that brings together preventive screening, laboratory testing, personalized treatment support, and ongoing care.
“Cervical cancer is one of the most preventable cancers, yet millions of women remain unscreened because traditional models of care don’t work for everyone,” said Oonagh O’Brien, Chief Executive Officer of LetsGetChecked. “By expanding our women’s health offerings with an at-home HPV testing solution, we’re making it easier for our partners to deliver evidence-based preventive care and giving individuals high-quality screening on their own terms.”
The Onclarity™ HPV Self-Collection Kit is tested with the BD Onclarity™ HPV Assay, which detects 14 high-risk HPV genotypes to identify oncogenic risk and is the only FDA-approved HPV assay to identify six individual genotypes and three groups of pooled results, making it the most comprehensive HPV screening tool available in the U.S. today. Results from the extended genotyping can enable timely referral to a specialist in high-risk cases and avoid unnecessary follow-up testing in lower-risk patients.6
“Reaching the millions of women and persons with a cervix who remain unscreened or under-screened for cervical cancer will require new thinking and innovative approaches,” said Jane Montealegre, PhD, Associate Professor, Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX. “At-home HPV screening represents a major opportunity to reach women through transformative solutions, helping expand access to care and bringing us closer to the goal of eliminating cervical cancer.”
About LetsGetChecked powered by Fuze Health
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, genetic sequencing, virtual care and medication delivery for a wide range of health conditions. LetsGetChecked is part of Fuze Health, a technology-powered home health screening, genomics and pharmacy services provider committed to transforming patient experiences and enabling healthcare partners – including care providers, health plans, employers and life sciences companies – to excel in an outcomes-focused system.
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Source(s):
- Cancer Trends Progress Report. National Cancer Institute, NIH, DHHS, Bethesda, MD, April 2025, https://progressreport.cancer.gov.
- Sk Abd Razak R, Amsah N, Heng PP, Jane Ling MY, Mohtar N, Masdor NA, Othman R, Hod R, Idris IB. Barriers and facilitators of cervical cancer screening among female healthcare professionals: a systematic review. BMC Public Health. 2026. doi:10.1186/s12889-026-27501-2.
- U.S. Centers for Disease Control and Prevention. Cancer: Reducing Structural Barriers Planning Guide. Published May 21, 2024. Accessed April 30, 2026, at https://www.cdc.gov/cancer/php/ebi-planning-guides/reducing-structural-barriers-planning-guide.html.
- Farajimakin O. Barriers to Cervical Cancer Screening: A Systematic Review. Cureus. 2024;16(7):e65555.doi:10.7759/cureus.65555.
- LetsGetChecked Receives U.S. Food and Drug Administration (FDA) De Novo Authorization for At-Home Chlamydia and Gonorrhea Testing System
- BD Onclarity™ HPV Assay US Package Insert [8089894]
Contacts
Keegan Calligar
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