News

Avero Diagnostics Expands Women’s Health Testing Portfolio With Launch of BD SurePath^TM and Onclarity^TM HPV Assay

April 18, 2022

Avero Diagnostics is pleased to announce the expansion of its women’s health testing portfolio with the addition of the BD SurePath^TM Liquid-based Pap Test and the Onclarity^TM HPV Assay. The BD Onclarity^TM HPV Assay with extended genotyping is the only FDA-approved HPV test that individually identifies HPV 31, which poses a similar risk for cervical precancer as compared to HPV 18 and should be managed similarly.^1-4

The BD Onclarity^TM HPV Assay with extended genotyping allows for a more precise, accurate way to measure a woman’s risk for developing cervical precancer compared to an assay with partial genotyping.^{2,3, 7-10} This assay brings value to clinical decision-making through specific, actionable insights on an extended set of HPV genotypes, helping providers effectively and efficiently manage patients.

Shaping the future of cervical cancer screening with the BD Onclarity^TM HPV Assay.

• The only FDA-approved HPV assay that offers extended genotyping^5.6
• Provides an individual result for HPV 31, which poses a similar or higher risk for cervical precancer as compared to HPV 18^1,3
• Individually identifies 6 high-risk HPV genotypes to allow for genotype-specific HPV persistence tracking, the most important determinant of cervical cancer risk in women who test HPV-positive^2,5-9
• FDA approved for the three most-common cervical cancer screening paradigms offering the flexibility you need to adapt to changing screening guidelines^5.6
• Consensus guidelines favor a personalized risk-based management of cervical cancer screening results with HPV testing as the foundation for risk estimation⁴

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health^TM by improving medical discovery, diagnostics and the delivery of care. The company offers complete solutions, combining products, recognized expertise and a full range of services to support laboratories and health care professionals in cervical cancer screening and clinical management of patients. Through the development of novel molecular oncology products, BD is focused on next-generation solutions in the field of cervical, ovarian, and breast cancer.

For more information about BD Onclarity^TM HPV Assay, please visit womens-health-solutions.bd.com

References

1. Monsonego J et al. Gynecol Oncol. 2015;137(1):47–54.
2. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1-13.
3. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.
4. Perkins RB et al. J Low Genit Tract Dis. 2020;24:102–31.
5. Salazar K et al. J Am Soc Cytopath. 2019;8:284–92.
6. BD Onclarity HPV Assay US Package Insert [8089894].
7. Elfgren K et al. AM J Obstet Gynecol. 2017;216(3):264e1–e7.
8. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.
9. Bodily J, Laimins LA. Trends Microbiol. 2011;19(1):33–9.
10. Bonde J et al. Int J Cancer. 2019;145:1033–41.