Planning the future of diagnostic testing systems and cervical cancer screening


By Brooke Story


The global pandemic has impacted women’s healthcare in ways that must be addressed immediately. It is imperative that every woman has access to cervical cancer screening. According to the Center for Disease Control and Prevention, an estimated 41% of U.S. adults have delayed or avoided medi- cal care because of the pandemic1 decline in cancer screening2


, leading to a substantial .


In addition to the impact of the pandemic making screenings harder to get (or patients avoiding them based on lock-down constraints and fear of infection), changing patient manage- ment guidelines can make it difficult for patients and clinicians to keep up on new testing recommendations. Furthermore, income and education disparities continue to impact when and how women get screened and treated for health issues. In the U.S., it is estimated that about 12,000 new cases of HPV-associated cervical cancer are diagnosed each year3


.


Often, Black, and Hispanic women have a higher likelihood of getting diagnosed with these types of cancers4


, possibly


because of having less access to screening tests or follow-up treatment.


As more women in the U.S. get vaccinated against two highly dangerous strains of HPV (HPV 16 and 18) and those strains decrease in prevalence, it is increasingly crucial to identify the other high-risk HPV genotypes (an individual’s collection of genes)5,6


. Only an HPV assay with extended


genotyping can identify and track high-risk HPV genotypes beyond HPV 16 and 18, including HPV 31 compared to other FDA-approved HPV tests7-12 The BD Onclarity™


.


assay available today that provides extended genotyping, including HPV 3111-16


HPV assay is the only FDA-approved . Screening is evolving into using an HPV


test with extended genotyping to ensure patients receive the most precise risk estimate for developing cervical pre-cancer and cancer per American Cancer Society guidelines. Run on the BD COR™


PX/GX System, which integrates robot-


ics and sample management software algorithms to automate the laboratory workflow from sample to diagnostic test result, the BD Onclarity™


HPV Assay with extended genotyping en-


ables high-throughput labs to both enhance and standardize the quality of results, improving the patient experience. The system itself is modular, scalable and designed to address multiple needs within laboratories for expanding molecular testing and increasing test volumes. Moreover, its onboard capacity for reagents and samples offers six to eight hours of unhindered system processing, eliminating multiple technologist interactions, therefore lessening the chance of human error. BD is actively working on further expanding the BD COR™


menu to help address women’s health issues. https://go.bd.com/onclarity 22 JANUARY 2022 MLO-ONLINE.COM


No other assay on the market today provides extended genotyping, which could be significant to patient care by unmasking other high-risk HPV strains11-16


. Being able to


identify extended genotypes specifically, as well as track those genotypes in a patient over time, allows for improved patient care and reduction of unnecessary additional test- ing. With extended genotyping, clinicians can recommend follow-ups rather than an immediate colposcopy that is not necessarily needed for the detected HPV strain. It is time to provide more advanced insight on women’s health and more informed treatment options for clinicians in the U.S. It is time for this comprehensive diagnostic approach to be made the norm.


Brooke Story is the Worldwide President at BD Integrated Diagnostic Solutions. Visit go.bd.com/onclarity to learn more about BD Onclarity™


HPV Assay and BD COR™ REFERENCES


1. MMWR, delay or avoidance of medical care because of COVID ... (n.d.). Retrieved October 28, 2021, from https://www.cdc.gov/mmwr/volumes/69/wr/ pdfs/mm6936a4-H.pdf.


2. Bakouny Z, Paciotti M, Schmidt AL, Lipsitz SR, Choueiri TK, Trinh Q. Cancer Screening Tests and Cancer Diagnoses During the COVID-19 Pandemic. JAMA Oncol. 2021;7(3):458–460. doi:10.1001/jamaoncol.2020.7600


3. National Program of Cancer Registries SEER*Stat Database: U.S. Cancer Statistics Incidence Analytic file 1998–2017. United States Department of Health and Human Services, Centers for Disease Control and Prevention. Released June 2020, based on the 2019 submission.


4. Viens LJ, Henley SJ, Watson M, Markowitz LE, Thomas CC, Thompson TD, Razzaghi H, Saraiya M, Centers for Disease Control and Prevention (CDC). Human papillomavirus–Associated cancers—United States, 2008–2012. MMWR 2016;65(26):661–666.


5. Schiffman M et al. J Clin Microbiol. 2015;53(1):52-59. 6. Perkins RB et al. J Low Genit Tract Dis. 2020;24:102-131. 7. Bonde J et al. Int J Cancer. 2019;145:1033-1041. 8. Elfgren K et al. AM J Obstet Gynecol. 2017;216(3):264e1-264.e7. 9. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768-772. 10. Bodily J, Laimins LA. Trends Microbiol. 2011;19(1):33-39. 11. Stoler MH et al. Gynecol Oncol. 2019;153(1):26-33. 12. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1-13. 13. Monsonego J et al. Gynecol Oncol. 2015;10:1016. 14. Schiffman M et al. Gynecol Oncol. 2015;138(3):573-578. 15. Schiffman M et al. Int J Cancer. 2016:139:2606-2615. 16. Schiffman M et al. J Clin Microbiol. 2015;53(1):52-59.


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