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The Onclarity™ HPV Self-Collection Kit sets a new standard for at-home cervical cancer screening in the United States
SOUTH SAN FRANCISCO, Calif.,June 25, 2026/PRNewswire/ -- Color Health, the leading nationwide virtual cancer clinic for full-spectrum cancer care, now provides the FDA-cleared Onclarity™ HPV Self-Collection Kit for at-home screening of human papillomavirus (HPV), the leading cause of cervical cancer. Color offers the swab-based kit through its ASCO-certified, oncologist-led Virtual Cancer Clinic serving employer, health plan, union, and public sector populations. The Onclarity™ HPV Self-Collection Kit, enabled by the BD Onclarity™ HPV Assay, which detects 14 high-risk HPV genotypes and uniquely distinguishes six individual genotypes and three strategically pooled results, offers the most comprehensive and informative HPV screening solution available in the U.S. today.
This new screening test is part of Color's comprehensive cancer screening and early detection program. Through its Virtual Cancer Clinic, Color provides additional at-home tests for other guideline-recommended cancer screenings, a high quality lower cost imaging screening network, and genetic risk testing. Color Medical's clinical team orders and follows up on every screening test, ensuring complete clinical management and accountability for the screening process. Color's program has demonstrated a 77% increase in screening adherence, including 100% clinical follow up for every abnormal result. The approach has been proven to reduce costs of care delivery relative to traditional network models and reduces time for patients to go from abnormal result to a cancer diagnosis by 66%.
HPV is a common sexually transmitted infection responsible for over 90% of cervical cancer cases. Yet one in four eligible women are not up to date with cervical cancer screening, and 60% of cervical cancers occur in people who haven't been screened in the last five years or ever.
"Cervical cancer is one of the most preventable cancers yet too many people remain unscreened due to barriers like access, time, and discomfort with in-clinic exams," said Dany Matar, Chief Operating Officer, Color Health. "Screening is a process, not a one-time test, and Color is unique in integrating this process into an expert clinical model that ensures not only that this screening is more accessible for patients, but that every screening follow-up happens quickly. Providing this new option through Color's Virtual Cancer Clinic broadens access to convenient high-quality testing for our patients."
Self-collection makes screening more accessible to patients who may find traditional pelvic exams uncomfortable or who face other barriers to care. Further, the Onclarity™ HPV Self-Collection Kit enabled by the Onclarity™ HPV Assay is the only FDA-approved HPV test with both extended genotyping† of individual results beyond HPV 16, 18, 45 and the option of self-collection.*
"Despite cervical cancer being preventable, a woman dies from the disease every 90 seconds. Expanding access to screening is critical, and at-home HPV self-collection removes barriers that keep people from getting screened. Extended genotyping is another significant advance, allowing clinicians to identify high-risk HPV types and enable more precise risk assessment and tailored care." said Jeff Andrews, M.D., FRCSC, Vice President of Medical Sciences, Waters Advanced Diagnostics, Waters Corporation. "We are pleased to expand access to cervical cancer screening with the Onclarity™ HPV Self-Collection Kit and approved BD Onclarity™ HPV Assay, the most comprehensive HPV screening tool available in the U.S. today, through strategic distribution partnerships."
About Color Health
Color's Virtual Cancer Clinic, powered by Color Medical's 50-state, oncologist-led medical group, has transformed cancer care for employers, health plans, unions and the public sector. Combining technology and AI with a fully integrated medical group, Color's ASCO-certified virtual clinic broadens access to best-in-class care, and lowers costs by avoiding late-stage diagnoses. Color identifies high-risk members, detects cancer earlier through guidelines–based screening, improves outcomes for patients in active treatment, and fully supports the unique needs of cancer survivors. Connect with Color on LinkedIn, X, andColor.com.
The BD Biosciences and BD Diagnostic Solutions businesses have been acquired by Waters Corporation ("Waters"). Becton, Dickinson and Company or one of its affiliates or subsidiaries ("BD") remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed. During this interim period, BD maintains full responsibility for all regulatory obligations of the legal manufacturer. Product information provided here is supplied under BD's regulatory authority. To learn more about the relationship between Waters and BD during this transition period, please see our detailed summary:www.waters.com/bdtransaction.
*Self-collected vaginal specimens can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.
†There are currently two FDA-approved HPV tests with extended genotyping with different configurations. The BD Onclarity™ HPV Assay individually identifies 6 high-risk HPV genotypes and strategically groups 3 results for 8 moderate risk HPV genotypes
Media Contact:Color HealthAndy Killandy.kill@color.com
SOURCE Color Health