Cervical cancer is most commonly caused by HPV. As women catch up on missed diagnostic screenings, clinicians need tools that will be able to identify more precisely specific cancer-causing HPV genotypes.

By Molly Broache

Labs have always faced the challenge of balancing the clinical imperative of providing accurate results with the business imperative of managing costs. And it’s an unfortunate “new normal” that this challenge was worsened by the pandemic as lab professionals were stretched to their professional and personal limits. The potential impact of human error because a tech is burned out, or the sample quality is compromised because staff simply aren’t there to run them, can have life-threatening consequences.

Highly anticipated advanced and automated molecular diagnostic systems are emerging on the market. The value of automation and AI-developed algorithms to improve lab workflow, reduce the likelihood of human error, and enhance overall lab efficiency isn’t just a boon to the labs. These systems and the longer walk-away times allow lab techs to focus their skills, attention, and expertise on more complex work—and that focus can lessen the day-to-day ennui that leads to burnout.

The provision of more precise and accurate diagnostics is critical for labs and healthcare systems and ultimately, to patients. This is table stakes. But in today’s world where patients are catching up on missed screenings and recommitting themselves to ongoing healthcare, which puts added pressure on already-pressured labs, it’s that much more important to take advantage of instruments and assays that do more and do better. Cervical cancer screening is a perfect example.

More Genotypes Means More Precise Cervical Cancer Care

Cervical cancer is caused by the most common sexually transmitted infection, human papillomavirus (HPV). According to the CDC, every year in the United States 13,000 women are diagnosed with cervical cancer caused by HPV, and more than 4,000 women die from it.

These deaths are avoidable. Cervical cancer is avoidable through a combination of vaccination and screening.

The goal of regular cervical cancer screening is to detect pre-cancer before it develops into cancer. Of the more than 100 types of HPV, 14 of them are high risk for causing cervical cancer1. And while the good news is that the FDA-approved quadrivalent HPV vaccine that debuted in 2006 has proven to be highly effective at decreasing the prevalence of high-risk HPV types 16 and 182,3, the not-so-good news is that we’re now seeing an increase in HPV 31. HPV 31 poses a higher risk for cervical pre-cancer as compared to HPV 18.

Offering a cutting-edge approach to HPV testing, the BD Onclarity HPV Assay is the only FDA-approved test that screens for types 16, 18, and 31 uniquely in one test from one sample, allowing for a more precise, accurate evaluation of a woman’s risk for developing cervical pre-cancer and cancer compared to an assay with partial genotyping.

It’s designed to minimize the risk of false-negative results by including an internal cellular control, ensuring human cellular material is present, and targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can be deleted during HPV DNA integration.

Other HPV assays report the rest of the high-risk HPV genotypes in a single, pooled result, which may mask the true risk of CIN3+ disease due to HPV 31. Following the American Society for Colposcopy and Cervical Pathology (ASCCP) principle of “similar management for similar risk,” women with an immediate risk for CIN3+ disease above 4% should be referred to colposcopy. Women 25 years and older with HPV 31 and normal cytology had an immediate risk for CIN3+ of 7.5%4.

The BD Onclarity HPV Assay runs on the fully automated BD COR PX/GX System, which integrates robotics and sample management software to help enable high-throughput labs to improve and standardize the quality of diagnostic test results. And for smaller to medium volume labs, the BD Onclarity HPV Assay can run on the BD Viper LT.

The challenges faced by laboratories—increased demand burnout, and staffing shortages—coupled with the always-on demand and expectation for accuracy, precision and efficiency are ushering in a new, arguably overdue, era of diagnostics that will make a difference for lab techs; and the clinicians and patients they serve.


Molly Broache, BSN, MSN, WHNP, is the associate director of Medical Affairs at BD. For more information, visit womens-health-solutions.bd.com.


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 November 11, 2020. Accessed December 18, 2020.

2. Wright TC et al. Gynecol Oncol. 2019;153(2):259-265.

3. Drolet M et al. Lancet.2019;394(10197): 497-509

4. Stoler MH et al. Gynecol Oncol 2019;153(1):26–33.