FDA clears first comprehensive at-home Cervical Cancer screening tool.

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  "data": {
    "url": "https://www.pharmacytimes.com/view/fda-clears-first-comprehensive-at-home-cervical-cancer-screening-tool",
    "title": "FDA clears first comprehensive at-home Cervical Cancer screening tool.",
    "excerpt": "FDA clears first comprehensive at-home Cervical Cancer screening tool.\n\nWaters Corporation's Onclarity HPV Self-Collection Kit represents a significant advance in expanding access to cervical cancer screening outside the clinic.\n\nWaters Corporation announced that the FDA has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking what experts are calling a pivotal step toward eliminating longstanding barriers to cervical cancer screening.[1]\n\nA new option for at-home screening.\n\nWaters collaborated with the National Institutes of Health's National Cancer Institute through the Cervical Cancer 'Last Mile' Initiative SHIP trial (NCT06498661) to evaluate the accuracy of self-collection for Human Papillomavirus (HPV) testing. The resulting product is now the most comprehensive at-home cervical cancer screening option currently available.[1,2]\n\nThe BD Onclarity HPV Assay with extended genotyping is a multiplex real-time Polymerase Chain Reaction (PCR) assay for the qualitative detection of 14 high-risk HPV types, providing on-demand genotyping for individual results of HPV 16, 18, 45, 31, 51, and 52, with pooled results of additional genotypes. The Onclarity assay is the first FDA-approved test that reports 6 HPV strains individually, enabling those strains to be tracked over time, an important...",
    "summary": "Waters Corporation partners with National Institutes of Health.",
    "category": "partners_with",
    "found_at": "2026-04-09T03:14:35Z",
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    "confidence": 0.1254,
    "published_at": "2026-04-09T03:14:35Z",
    "article_sentence": "Waters collaborated with the National Institutes of Health's National Cancer Institute through the Cervical Cancer 'Last Mile' Initiative SHIP trial (NCT06498661) to evaluate the accuracy of self-collection for Human Papillomavirus (HPV) testing."
  }
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