The BD Onclarity™ HPV Assay gives you the most comprehensive and reliable HPV test results on the market to ensure a more precise and accurate cervical cancer risk assessment* – so you can better support your patients.1,3,5-9
BD Onclarity™ HPV Assay
BD Onclarity™ FDA trial
The BD OnclarityTM HPV Assay was extensively tested among women of different ages, ethnicities, and vaccination status in a prospective, multicenter clinical trial that enrolled more than 33,000 women.1
The primary objective was to determine the screening performance of the BD OnclarityTM HPV Assay in:
- Triage: Women ≥21 years with ASC-US cytology for detecting cervical cancer and precancer (≥CIN2)2
- HPV primary: Women ≥25 years for primary cervical cancer screening (HPV alone)1
- Co-testing: Women ≥30 years with normal cytology (NILM) as an adjunct test3
A secondary objective was to examine the contribution of individual hr-HPV genotypes to disease.
Triage:
Women ≥ 21 years with ≥ ASC-US cytology2
Performance of the BD OnclarityTM HPV Assay vs HC2 for detection of ≥CIN3 (n=35) in the ASC-US population*
Adapted from Wright TC et al. Am J Clin Pathol. 2019;151(1):53-62.
*Results are based on 1,601 women ≥ 21 yrs with consensus pathology results and HPV results with both the BD Onclarity™ HPV Assay and digene© Hybrid Capture 2 assays (paired analysis).
HPV primary:
Women ≥ 25 years for primary cervical cancer screening1
The primary screening algorithm with the BD Onclarity™ HPV Assay improves disease detection and reduces
the number of colposcopies versus cytology alone1
Performance of the BD Onclarity™ HPV Assay vs cytology alone for detection of ≥CIN3 in the ≥25 years population§
Adapted from Stoler MH et al. Gynecol Oncol. 2018;149(3):498–505.
§The use of the BD Onclarity™ HPV Assay as a first line screening method was evaluated by comparing the Primary
Screening algorithm (HPV 16 and 18 genotyping with reflex to cytology) with the Cytology algorithm (cytology alone)
Co-testing:
Women ≥ 30 years with normal cytology (NILM)3
Performance of the BD Onclarity™ HPV Assay vs HC2 for detection of ≥CIN3 (n=46) in the NILM ≥30 years population**
Adapted from Stoler MH et al. Am J Clin Pathol. 2019;151(4):433-442.
**Results represent p16INK4A immunostain-assisted adjudicated histology with HPV results by the BD Onclarity™ HPV Assay and digene© Hybrid Capture 2 assays (paired analysis).
#Verification bias adjusted value for specificity = 92.3%.
†Verification bias adjusted value for specificity = 93.3%
3-year longitudinal nation-wide study representative of the US population 33,858 women ≥21 years were enrolled during routine cervical cancer screening at 31 sites.
Adapted from Stoler MH al. Gynecol Oncol. 2018;149(3);498-505
The BD Onclarity™ FDA trial was a regulatory trial designed to obtain FDA-approval for hr-HPV testing and genotyping for HPV 16, 18, 45 and beyond1
For more information on the BD OnclarityTM FDA trial
Baseline BD OnclarityTM FDA trial
Stoler MH et al. Gynecol Oncol 2018;149(3):498–505.
BD OnclarityTM FDA trial in the ASC-US subpopulation
Wright TC et al. Am J Clin Pathol 2019;151(1):53–62.
BD OnclarityTM FDA trial in the NILM subpopulation
Stoler MH et al. Am J Clin Pathol 2019;151(4):433–442.
ASC-US, atypical squamous cells of undetermined significance; HC2, Hybrid Capture 2; HPV, human papillomavirus; hr, high risk; NILM, negative for intraepithelial neoplasia grade 1
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):433–42.
Sensitivity, specificity, negative predictive value & positive predictive value
Sensitivity:
the ability of a screening test to correctly identify all people with the condition from a group of people who are known to have the condition, aka the ability to detect a true positive
Specificity:
the ability of a screening test to correctly identify all people without the condition from a group of people who are known to not have the condition, aka the ability to detect a true negative
False positive:
A positive test result for someone who does not have the condition
False negative:
A negative test result for someone who has the condition
Trevethan R. Front Public Health. 2017;5:307.