In 2013 Hologic's APTIMA® HPV 16 18/45 genotype assay was FDA‐approved for genotyping human papillomavirus (HPV) types 16, 18 and/or 45. HPV genotype 45 is the third most common HPV genotype in invasive cancer. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates. Based on a clinical evaluation of more than 10,000 U.S. women with normal cytology results, the APTIMA HPV Assay has 24% fewer false positives than an FDA approved DNA test, thus targeting the right patients for colposcopy and minimizing the potential for harm.
Hologic Aptima HPV 16, 18/45 genotype assay
2.0 mL liquid cytology media (ThinPrep® PAP solution or SurePath™ Test Pack solution)
Ship at ambient
Insufficient specimen; Low sample cellularity
HPV HR type 16, 18/45 or 16/18/45 Detected/Not Detected
To be used adjunctively, with an FDA approved HPV high risk test, in patients with either a HPV HR+ ASC-US result or, in women 30 years of age and older, with a HPV HR+ primary screening result.
Hologic, Aptima and ThinPrep are registered trademark of Hologic Inc.
SurePath is a trademark of Becton, Dickinson and Company.