How was the clinical performance of the BD Onclarity™ HPV assay evaluated for high-risk HPV testing?

The BD Onclarity™ HPV Assay FDA Clinical Trial was the first premarket approval trial to evaluate the performance of extended genotyping beyond HPV 16 and HPV 18 in the USA.

Learn more about the performance of the BD Onclarity™ HPV Assay
How can extended genotyping help you prevent the development of cervical cancer?

Identifying genotypes beyond 16 and 18 enables you to more precisely identify the risk of developing cervical disease.

Learn more about the value of extended genotyping
DID YOU KNOW THAT ALL HIGH-RISK HPV TYPES HAVE DIFFERENT POTENTIAL TO CAUSE CERVICAL CANCER?

Risk stratification with the BD Onclarity™ HPV Assay allows you to focus on patients with the higher risks.

Learn more about how BD Onclarity™ HPV Assay works
Did you know that persistent HPV infections increase the risk of cervical cancer?

Monitoring HPV genotype-specific persistence is key to identifying those patients most at risk.

Learn more about the importance of persistence tracking
Did you know that three HPV types account for 94% of cervical adenocarcinomas?7

Extended genotyping could help you determine the risk for cervical adenocarcinoma.

Learn more about the challenge of adenocarcinomas
1 2 3 4 5

BD Onclarity™ HPV Assay
Extend the power of HPV testing

Cervical cancer is the 4th most frequent cancer in women1

~570,000 WOMEN
DIAGNOSED/YEAR1

~311,000
DEATHS/YEAR1

While preventable, cervical cancer takes a heavy toll.

The high mortality rate from cervical cancer globally, could be reduced through a comprehensive approach that includes prevention through vaccination, early diagnosis, effective screening and treatment programs.1

The use of high-risk human papillomavirus (HPV) testing is recommended in the latest guidelines of the American Cancer Society as well as in the European guidelines for quality assurance in cervical cancer screening.2-4

European guidelines, 20153
« Primary testing for oncogenic HPV can be used in an organized, population-based program for cervical cancer screening. »
ASCCP Guidelines, 20152,4
« Because of equivalent or superior effectiveness, primary high-risk HPV screening can be considered as an alternative to current US cytology-based cervical cancer screening methods. Cytology alone and co-testing remain the screening options specifically recommended in major guidelines. »

- European guidelines, 20153

- ASCCP Guidelines, 20152,4

THE BD ONCLARITY™ HPV ASSAY IS CLINICALLY VALIDATED TO SIMULTANEOUSLY DETECT
14 HIGH-RISK HPV GENOTYPES,* WITH INDIVIDUAL RESULTS FOR 6 GENOTYPES.5


*BD Onclarity™ HPV Assay detects the 14 high-risk HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 classified as carcinogenic, 68 classified as probably carcinogenic, and 66 classified as possibly carcinogenic to humans.5,6


Learn moreabout the BD Onclarity™ FDA trial
Know the HPV type, understand the risk
Not all high-risk HPV types are the same
Persistent infections increase risk
Detecting adenocarcinomas
is essential
Know the HPV type, understand the risk

HPV infection is a well-established cause of cervical cancer.1


HPV testing is a valuable tool in the fight against cervical cancer

  • Identify HPV types that cause cervical cancer and pre-cancer7-9
  • Predict the immediate and future risk of disease10,11
  • Determine the risk of adenocarcinoma8
  • Track persistence of genotype-specific HPV infection12
  • Monitor the impact of HPV vaccination

IDENTIFYING INDIVIDUAL HPV GENOTYPES ENABLES HEALTH CARE PROFESSIONALS TO MORE PRECISELY IDENTIFY THE RISK FOR DEVELOPING CERVICAL DISEASE.

†The 14 high-risk HPV types are 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 classified as carcinogenic, 68 classified as probably carcinogenic and 66 classified as possibly carcinogenic to humans.6


Learn moreClinical value of extended genotyping

Not all high-risk HPV types are the same

The 14 high-risk HPV types have very different potential to cause cervical cancer. Some HPV types are more prevalent while others that are less common, are linked to a higher risk of cancer.

Risk profile of different HPV types

The 9-valent HPV vaccine (9vHPV) targets HPV types 6, 11, 16, and 18 (targeted by the quadrivalent HPV vaccine (4vHPV)), as well as five additional types, HPV types 31, 33, 45, 52, and 58.

High risk of disease
HPV 16, 18, 45
70% of all cervical cancers7,8 94% of adenocarcinomas7

Moderate risk of disease HPV 31, 33, 58 52
20% of all cervical cancers7,8

Lower risk of disease
HPV 51, 35, 39, 68, 56, 59, 66

The bd onclarity™ hpv assay is a real-time pcr assay designed with risk stratification in mind, allowing YOU TO IMMEDIATELY FOCUS ON THOSE PATIENTS MOST at risk.9





Learn moreBD Onclarity™ HPV Assay
Persistent infections increase risk of disease; know the history

Women with persistent genotype-specific infection have a higher risk of developing a cervical cancer.12


Among women with persistent genotype-specific HPV infection
ALL WOMEN (40/40) DEVELOPED
a ≥CIN2 disease12
Among women with genotype switch or cleared HPV infection
NO WOMEN (0/35) DEVELOPED
a ≥CIN2 disease12

MONITORING GENOTYPE-SPECIFIC PERSISTENT INFECTIONS IS KEY TO IDENTIFYING YOUR PATIENTS WHO ARE AT MOST RISK FOR DEVELOPING CERVICAL DISEASE.12

Learn moreThe importance of persistence tracking What is CIN?
Detecting adenocarcinomas is essential

Pap screening has dramatically reduced the incidence of squamous cell cancers but not the incidence of adenocarcinomas.13,14



Adenocarcinomas represent as much as 30% of all cervical cancers in many countries.14

Squamous cell cancers

Adenocarcinomas are poorly diagnosed by cytology because they do not reach the superficial part of the gland and do not shed exfoliative cells.14-16

Delays in diagnosis could be responsible for the poorer prognosis associated with these cancers.14

THE BD ONCLARITY™ HPV ASSAY CAN HELP DETERMINE THE RISK FOR ADENOCARCINOMA USING EXTENDED GENOTYPING.5,8



Learn moreThe challenge of adenocarcinomas
  • 4vHPV, quadrivalent HPV vaccine;
  • 9vHPV, nonavalent HPV vaccine;
  • ASCCP, American Society for Colposcopy and Cervical Pathology;
  • 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;
  • HPV, human papillomavirus;
  • hrHPV, high-risk human papillomavirus;
  • PCR, polymerase chain reaction.
  1. World Health Organization. Human papillomavirus (HPV) and cervical cancer. Available at: https://www.who.int/news-room/fact-sheets/detail/human-papillomavirus-(hpv)-and-cervical-cancer. Last updated 11 November 2020. Accessed 9 June 2021.
  2. Saslow D et al. CA Cancer J Clin. 2012;62(3):147-172.
  3. European Commission. European guidelines for quality assurance in cervical cancer screening - Second Edition, Supplements. 2015.
  4. Huh WK et al. J Lower Gen Tract Dis. 2015;19(2):91-96.
  5. BD Onclarity™ HPV Assay European Product information, 8089899(14). Updated November 2020.
  6. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. IARC Monogr Eval Carcinog Risks Hum. 2012;100(B):1-441.
  7. Li N et al. Int J Cancer. 2011;128:927-935.
  8. de Sanjose S et al. Lancet Oncol. 2010;11:1048-1056.
  9. Bottari F et al. J Clin Microbiol. 2015;53:2109-2114.
  10. Stoler MH et al. Gynecol Oncol. 2019,153(1):26-33.
  11. Schiffman M et al. Int J Cancer. 2016;139(11):2606-2615.
  12. Elfgren K et al. Am J Obstet Gynecol 2017;216(3):264.e1-7.
  13. Adegoke O et al. J Womens Health. 2012;21(10):1031-1037.
  14. Kyrgiou M et al. Br J Cancer. 2020;123(4):510-517.
  15. Katki HA et al. Lancet Oncol. 2011;12(7):663-672.
  16. Vaughan LM and Malinowski DP. Rev Bras Ginecol Obstet. 2019;41(5):357-359.