Recently Approved Device: BD Onclarity HPV Assay

FDA has recently approved the Becton Dickinson (BD) Onclarity HPV Assay to be marketed. This is an automated laboratory test used on the BD Viper LT system. This test detects DNA (deoxyribonucleic acid) from 14 high risk human papillomavirus (HPV) types that are associated with cervical cancer. 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. Human papillomaviruses (HPVs) are a group of over 150 related viruses. Each HPV virus in this large group is given a number which is called its HPV type. Some HPV types can lead to cancer. HPV is transmitted through intimate skin-to-skin contact.