TEST:

BD Onclarity™ HPV Assay

The self-collect device shows high (>92%) positive and negative agreement for detection of HPV when compared with reference clinician-collected samples, with very high acceptability and preference. Furthermore, the self-samples collected with the self-collect device showed highly concordant results by dual stain, which is a novel and emerging application for a self-collected sampling device, thus enabling potential triage from 1 sample.

P=N/A; Understanding the degree of concordance among different assays targeting either HPV presence/type(s) or cellular morphology and proteins' expression provides knowledge useful to better define how these tests can be used in screening protocols for an effective triage and to anticipate the possible implementation issues. Our study shows that the concordance between tests is higher when the infections have a higher probability of producing a clinically relevant lesion.

"A first of its kind Human Papillomavirus (HPV) self-collection screening pilot program aimed at improving cervical cancer screening in underserved communities has officially launched in Texas. HPV is the cause of virtually all cervical cancers...This initiative will be using the BD Onclarity™ HPV Assay from BD (Becton, Dickinson and Company)...which was approved earlier this year by the U.S. Food and Drug Administration (FDA) for HPV self-collection screening in health care settings."

The DNA level for various HR-HPV types increased with histological severity from normal tissue to cancer, which might impact the performance of Aptima HPV assay. Both assays showed similar sensitivity and predictive values for detecting CIN2+ lesions.

"Becton, Dickinson and Company...announced today Health Canada approval of the BD Onclarity™ HPV Assay for human papillomavirus (HPV) testing for the use with self-collected vaginal specimens at home."

However, the sensitivity was not high in spot urine. Therefore, further large-scale studies are needed to verify these findings and optimize testing methods to encourage broader participation in cancer screening programs.

Enrolled were 1104 women, mean age 41.3 years, 58.7% were HNW. The sensitivity/specificity/PPV/NPV of the different tests to detect CIN3+ in HNW were: Onclarity® 63.8%/82.3%/38.1%/94.7%; HC2 59.2%/83.8%/27.9%/95.1%; Roche cobas® 68.2%/81.6%/29.6%/95.8%; GeneXpert 64.1%/85.1%/33.6%/95.3%; Aptima 36.2%/90.0%/29.2%/92.5% and PreTect-Proofer-8 24.4%/87.6%/13.7%/93.5%. In HPW, respective sensitivity/specificity/PPV/NPV to detect CIN3+ were: Onclarity 80.8%/67.5%/44.7%/91.6%; HC2 77.1%/63.0%/36.0%/91.1%; Roche cobas® 82.1%/61.7%/39.4%/91.9%; GeneXpert 80.2%/64.4%/40.7%/91.4%; Aptima 42.2%/77.0%/36.8%/80.8% and PreTect-Proofer-8 46.4%/66.4%/28.5%/81.1%.

"Four tests fulfilled the new criteria: (1) RealTime High-Risk HPV Test (Abbott), (2) Cobas-4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately."

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The MolecuTech Real HPV 16/18/HR assay showed good agreement in the detection of HR HPV genotypes, and similar analytical performance for the detection of HR HPV genotypes in samples with abnormal cytological findings.

P=N/A; Among the baseline HPV DNA positive/cytology or DS negative women, the extended genotyping allows to stratify for risk of CIN3+, and to identify a group of women with a risk of CIN3+ so low in the next 24 months that they could be referred to a new screening round after 3 years.

P=N/A; N=200; Recruiting; Sponsor: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.

Supported By BD

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

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.