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 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
How to interpret cytology results?
1,2
A Pap test (or cytology test) looks for precancerous cervical cells. The results can be normal, unclear or abnormal.
≥ASC-US collectively refers to unclear and abnormal results
>ASC-US refers to abnormal results
1.
Nayar R, Wilbur D (Eds). The Bethesda system for reporting cervical cytology. Definitions, criteria, and explanatory notes. Third Edition. New-York:Springer; 2015.
2.
ACS. The Pap (Papanicolaou) Test. Available at: https://www.cancer.org/cancer/cervical-cancer/detection-diagnosis-staging/screening-tests/pap-test.html. Accessed 30 April 2020.
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
Trial design
1
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 et al. Gynecol Oncol. 2018;149(3):498-505.
.
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*
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§
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).
WHAT IS SPECIFICITY/SENSITIVITY?
Sensitivity (or “true positive” rate) measures how often a test correctly generates a positive result. A high-sensitivity test flags almost everyone who has the disease and does not generate many false-negative results.
Specificity (or “true negative” rate) measures a test’s ability to correctly generate a negative result. A high-specificity test correctly rules out almost everyone who does not have the disease and will not generate many false-positive results.
Positive predictive value is the probability that subjects with a positive screening test truly have the disease.
Negative predictive value is the probability that subjects with a negative screening test truly don't have the disease.
WHAT IS SPECIFICITY/SENSITIVITY?
Sensitivity (or “true positive” rate) measures how often a test correctly generates a positive result. A high-sensitivity test flags almost everyone who has the disease and does not generate many false-negative results.
Specificity (or “true negative” rate) measures a test’s ability to correctly generate a negative result. A high-specificity test correctly rules out almost everyone who does not have the disease and will not generate many false-positive results.
Positive predictive value is the probability that subjects with a positive screening test truly have the disease.
Negative predictive value is the probability that subjects with a negative screening test truly don't have the disease.
WHAT IS SPECIFICITY/SENSITIVITY?
Sensitivity (or “true positive” rate) measures how often a test correctly generates a positive result. A high-sensitivity test flags almost everyone who has the disease and does not generate many false-negative results.
Specificity (or “true negative” rate) measures a test’s ability to correctly generate a negative result. A high-specificity test correctly rules out almost everyone who does not have the disease and will not generate many false-positive results.
Positive predictive value is the probability that subjects with a positive screening test truly have the disease.
Negative predictive value is the probability that subjects with a negative screening test truly don't have the disease.
For more information on the BD Onclarity™ HPV Assay FDA Clinical Trial