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FDA Approves BD Onclarity HPV Assay
Devices Submissions and Approvals
The FDA approved the Becton Dickinson Onclarity human papillomavirus assay for marketing.
HPVs are a group of over 150 related viruses. The assay detects DNA from 14 high risk human papillomavirus types that are associated with cervical cancer.
The automated laboratory test is used on BD’s Viper LT system. The test specifically identifies HPV types 16, 18 and 45 while concurrently detecting types 31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68.