The BD
Onclarity™
HPV Assay
FDA
Clinical Trial:
Evaluating the performance of extended genotyping beyond HPV 16 and HPV 18
The BD Onclarity™ HPV Assay FDA Clinical Trial1 was a regulatory trial designed to obtain FDA approval in the USA for high-risk HPV testing and genotyping for HPV 16, 18, 45 and beyond.
The first premarket approval trial to evaluate the performance of extended genotyping beyond HPV 16 and HPV 18 in the USA.
The second largest prospective HPV study in a screening population enrolling more than 33,000 women.
BD Onclarity™ HPV Assay is FDA-approved for high-risk HPV testing
The BD Onclarity™ HPV Assay was clinically validated in the BD Onclarity™ HPV Assay FDA Clinical Trial for:1
- Triage in women ≥21 years with ASC-US cytology undergoing cervical cancer screening1
- High-risk HPV co-testing with cytology3
- Primary cervical cancer screening in women ≥25 years4
How to interpret cytology results?1,2
BD Onclarity™ HPV Assay FDA Clinical Trial description
The BD Onclarity™ HPV Assay FDA Clinical Trial1 was a regulatory trial designed to obtain FDA-approval in the USA for high-risk HPV testing and genotyping for HPV 16, 18, 45 and beyond.
This study was conducted in two phases: a baseline and a three-year longitudinal phase
- The baseline phase of the BD Onclarity™ HPV Assay FDA Clinical Trial was conducted to determine the screening performance of the BD Onclarity™ HPV Assay versus digene® Hybrid Capture 2 (HC2)
– for detecting cervical cancer and precancer (≥CIN2) during triage of women ≥21 years with cytology presenting atypical squamous cells of undetermined significance (ASC-US),
– as an adjunct test in women ≥30 years with normal cytology (NILM),
– for primary screening (HPV alone) in women ≥25 years. - A secondary objective was to examine the contribution of individual high-risk HPV genotypes to disease
Trial design1
For more information on the BD Onclarity™ HPV Assay FDA Clinical Trial
Triage of women* ≥21 years with ASC-US cytology
HPV Co-testing in women ≥30 years with NILM cytology
Primary cervical cancer screening in women ≥25 years
For more information on the BD Onclarity™ HPV Assay FDA Clinical Trial
ASC-US, atypical squamous cells of undetermined significance; ≥ASC-US, atypical squamous cells of undetermined significance or greater; CI, confidence interval; CIN, cervical intraepithelial neoplasia; CIN1, cervical intraepithelial neoplasia grade 1; CIN2, cervical intraepithelial neoplasia grade 2; CIN3, cervical intraepithelial neoplasia grade 3; FDA, Food and Drug Administration; HC2, digene® Hybrid Capture 2; HPV, human papillomavirus; hrHPV, high-risk human papillomavirus; HSIL, high grade squamous intraepithelial lesion; LSIL, low grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesions or malignancies; p16, p16INK4A protein; SCC, squamous cell carcinoma; UNSAT, unsatisfactory cytology result; USA, United-States of America; VBA, verification bias adjustment.
1. Stoler MH et al. Gynecol Oncol. 2018;149(3):498-505.
2. Wright TC et al. Am J Clin Pathol. 2019;151(1):53-62.
3. Stoler MH et al. Am J Clin Pathol. 2019;151(4):433-442.
4. BD Onclarity™ HPV Assay European Product information, 8089899(14). Updated November 2020.