TEST:

BD Onclarity™ HPV Assay

P=N/A, N=200, Recruiting, European Institute of Oncology

"BD (Becton, Dickinson and Company)...announced a strategic partnership with Camtech Health, a digital health company focused on at-home health testing, to advance cervical cancer screening by offering the first-ever option for women in Singapore to self-collect a sample in the privacy of their own home."

In this study, the performance of BD Onclarity HPV on FLOQSwab-collected vaginal self-samples has been compared to clinician-taken liquid-based cytology samples, to detect high-grade cervical intraepithelial neoplasia using two high-throughput platforms, BD Viper LT and BD COR. The study findings have shown a similar performance of BD Onclarity on testing self-collected samples, confirming the validation of the proposed pre-analytical and analytical protocols for their use in cervical cancer screening programs based on self-collected vaginal samples.

Extended genotyping enables the identification of the most common oncogenic HPV types in the population. It can be used as a basic tool for secondary prevention or together with LBC.

Our study showed a substantial agreement between Self-Sentis HPV with Clinician-Sentis HPV and Clinician-Onclarity. Self-sampling was also shown to be a generally well-accepted method of screening.

These results support the theoretical efficacy of HPV-AVE-based risk estimation for cervical screening. If HPV testing can be made affordable, cost-effective and point of care, this risk-based approach could be one management option for HPV-positive women.

The index and predicate HPV assays demonstrated equivalent performance, and extended HPV genotyping, using the index assay, provided effective ≥CIN2 and ≥CIN3 risk stratification, supporting a new indication for use of the index assay with PreservCyt.

xGT performed similarly compared to HPV primary screening plus DS for detection of high-grade CIN. xGT provides results that stratify risk in a flexible and reliable manner for colposcopy risk thresholds set by different guidelines or organizations.

Conclusions Onclarity and cobas show equivalent performance using PreservCyt LBC media, and Onclarity genotyping provides effective ≥CIN2 and ≥CIN3 risk stratification. This real-world evidence study involved a unique, population-based design and a rapid, cost-effective approach to support a new HPV-device indication that would offer many additional healthcare providers in the United States a risk-based approach for management through extended genotyping.

"BD (Becton, Dickinson and Company)...announced U.S. Food and Drug Administration (FDA) market approval for the BD Onclarity™ HPV Assay to be used with the ThinPrep® Pap Test...The inclusion of the ThinPrep® Pap Test improves access to the benefits of the BD human papillomavirus virus (HPV) assay, which is the only FDA-approved assay that tests for an extended set of HPV types individually, and particularly for HPV31, a specific type of HPV that poses a high-risk for causing cervical cancer."

An HPV-negative result offers the same assurance of no disease over three years of follow up as that offered by a negative co-testing result. xGT facilitates risk-based screening and persistence tracking and can help optimize disease detection during screening without excessive colposcopic procedures.

Across all HPV genotypes, DS-negative patients were reassured of very low risk, which would not require colposcopy. Extended genotyping providing four HPV risk groups paired with DS provides more efficient triage compared to current cytology-based approaches.

It is likely that the future of cervical screening will involve a precision medicine-based approach. This study evaluates different approaches in a longitudinal study which has followed women through at least one round of cervical screening.

HPV tests showed a good concordance with HC2 and a very good and comparable sensitivity in CIN2+ detection. Hence, an HPV test represents a valid option as test-of-cure in order to monitor patients treated for CIN2+ lesions during follow-up.

No difference for ?CIN2 sensitivity was observed between Onclarity and cobas (both 96.5%), whereas the ?CIN2 specificity for detection of Onclarity (16.6%, 95% CI: 13.7-19.9) was higher than that of cobas (11.5%, 95% CI: 9.1-14.5). Onclarity exhibited comparable screening performance and triage efficiency compared to cobas in detection of cervical disease in Chinese women.

Multiple HPV infections have distinct clinicopathological characteristics (compared with single HPV infection). As their biological behavior is uncertain, close and frequent follow-up is warranted.

VALHUDES study showed that HPV testing with Onclarity HPV on vaginal self-samples is similarly sensitive compared to cervical specimens. However, differences in accuracy by self-sampling devices, although not significant, were noted. Onclarity HPV testing on vaginal self-samples following validated collection and handling procedures may be used in primary cervical cancer screening.

BD Onclarity HPV Assay on first-void urine has similar clinical sensitivity and somewhat lower specificity to detect cervical precancer to testing on clinician-collected cervical samples.

Full genotyping with Anyplex might confer additional benefits to patients with ≥CIN 2, although the difference is small. We also suggest an optimal cutoff value when reporting HPV infections using the Anyplex assay (≥2+; medium viral loads).

HPV31 may be an important genotype in the triage of women positive for hrHPV.

Our findings indicate that liquid based methods for HPV determination is superior to p16 immunostaining on Cellient® cell blocks.

When p16 is positive, HPV-specific testing is necessary. The identification of less common high-risk HPV types, HPV-52 and HPV-31, may influence current local vaccination strategies.

Dr. Mayrand will give her perspective summation of the three presentations before fielding questions from the audience for the panel.

Supported By BD

The Onclarity-COR instrument fulfills international validation criteria on sensitivity, specificity, and laboratory reproducibility. The Onclarity assay's extended genotyping capability, together with its high-throughput characteristics, makes the COR instrument an excellent candidate for use in human papillomavirus primary cervical cancer screening.

Both assays are reliable methods for high-risk HPV detection and genotype determination in FFPE specimens, with high PPV and specificity. The Aptima HPV assay has the advantage of higher sensitivity. As far as we are aware, this is the first study comparing the Aptima HPV assay and the BD Onclarity assay in FFPE tissues. Our study results should be tested and confirmed in larger cohorts.

The highest five-year survival rate in oropharyngeal HPV patients in our population is also in agreement with previous data in the literature. As a limitation of the study, multivariate analysis was not performed due to a low HPV positivity in our sample.