CLN - Industry Insights

Driving impact in women’s health: The BD COR™ System and BD Onclarity™ HPV Assay

Danielle Clement, MEd, MSN, WHNP-BC, AGNP-C Senior clinical marketing manager, U.S. Molecular Diagnostics

Today’s high-volume molecular laboratories demand solutions that deliver efficiency, accuracy, and scalability — especially in women’s health. The BD COR™ System rises to meet this need, combining high-throughput automation, powerful informatics, and a growing menu of molecular assays that streamline workflows and help improve patient management.

At the center of this platform is the BD Onclarity™ HPV Assay, the first Food and Drug Administration (FDA)-approved DNA-based human papillomavirus (HPV) test with extended genotyping, validated for use across all major cervical cancer screening methods. BD Onclarity™ HPV Assay supports HPV primary screening, co-testing (HPV + Pap), reflex testing, and self-collected vaginal samples obtained in a healthcare setting — giving providers ultimate flexibility in how they screen patients. The assay is compatible with both BD SurePath™ and Hologic ThinPrep® Pap vials, supporting the two most common sample types used in U.S. laboratories. With extended genotyping beyond 16, 18, and 45 available across all methods, BD Onclarity™ HPV Assay enables more precise risk stratification and better patient management in alignment with evolving clinical standards.

The BD COR™ System delivers true end-to-end molecular automation, with minimal hands-on time and high throughput without compromising quality. Its scalable, modular design adapts to the needs of regional and national laboratories, helping them meet growing demand while maintaining traceability and compliance.

Complementing BD Onclarity™ HPV Assay, the BD CTGCTV2 assay is an FDA-cleared 3-in-1 test that detects the most common non-viral sexually transmitted infections — chlamydia, gonorrhea, and trichomoniasis. The BD Vaginal Panel complements the women’s health offering, offering the first FDA-authorized, microbiome-based PCR test for vaginitis, which can diagnose the three most common infectious causes from a single swab.

Labs running BD COR™ System can leverage BD Synapsys™ Informatics, a secure, browser-based platform that automates instrument maintenance, tracks sample traceability, and integrates seamlessly with laboratory information systems — empowering labs to deliver fast, actionable results.

Together, the BD COR™ System and its growing assay menu are advancing the future of women’s health, delivering clinically meaningful answers that support earlier diagnosis and help improve patient management.

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