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The BD Onclarity™
HPV Assay FDA Clinical Trial

The BD Onclarity™ HPV Assay FDA Clinical Trial 1 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 biggest prospective HPV study in a screening population enrolling more than 33,000 women.


BD Onclarity™ HPV Assay 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 screening 2
  • High-risk HPV co-testing with cytology 3
  • Primary cervical cancer screening in women ≥25 years 4

BD Onclarity™ HPV Assay FDA Clinical Trial description

The BD Onclarity™ HPV Assay FDA Clinical Trial 1 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

Clinical performance of the BD Onclarity™ HPV Assay

The BD Onclarity™ HPV Assay demonstrated equivalent performance to the FDA-approved reference method in the ASC-US population2

Performance of the BD Onclarity™ HPV Assay vs HC2 for detection of ≥CIN3 (n=35) in the
ASC-US population2*
tab_a_image
  • BD Onclarity™ HPV Assay
  • HC2
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).

The BD Onclarity™ HPV Assay demonstrated equivalent performance to the FDA-approved reference method in the NILM population3

Performance of the BD Onclarity™ HPV Assay vs HC2 for detection of ≥CIN3 (n=46) in the NILM ≥30 years population3**
tab_b_image
  • BD Onclarity™ HPV Assay
  • HC2
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%.

The primary screening algorithm with the BD Onclarity™ HPV Assay improves disease detection and reduces the number of colposcopies versus cytology alone4

Performance of the BD Onclarity™ HPV Assay vs cytology alone for detection of ≥CIN3 in the ≥25 years population4§
tab_c_image
  • the BD Onclarity™ HPV Assay
    Primary Screening algorithm
  • Cytology algorithm
Adapted from BD Onclarity™ HPV Assay European Product information.
§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).

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. 1. Stoler MH et al. Gynecol Oncol. 2018;149(3):498-505.
  2. 2. Wright TC et al. Am J Clin Pathol. 2019;151(1):53-62.
  3. 3. Stoler MH et al. Am J Clin Pathol. 2019;151(4):433-442.
  4. 4. BD Onclarity™ HPV Assay European Product information, 8089899(14). Updated November 2020.