The CDC and American Cancer Society reported there are approximately 14,000 total new cases of cervical cancer in the U.S. each year and about 4,000 deaths. Almost all of these are preventable.
Primary prevention is achieved by effective HPV vaccination programs. Secondary prevention is achieved by effective screening programs that detect pre-cancer. HPV is the cause of cervical cancer. The current best practice screening is called primary HPV screening; meaning that HPV — not Pap — is done first and then if that result is positive, more testing follows.
Modern precision medicine includes risk-based screening. When the calculated risk is above a pre-specified threshold, then a particular action is recommended, which could be more testing or a treatment. When the calculated risk is below the threshold, then watchful waiting may be recommended. For a positive HPV result during screening, both the WHO and ASCO recommend either cytology or partial/extended genotyping as a triage to identify women at high-risk of developing cancer or pre-cancer.
Genotyping refers to using the differential risk posed by individual genotypes to stratify a woman’s risk for cancer or pre-cancer and give personalized recommendations. The three genotypes that pose the highest risk for pre-cancer are 16, 31 and 18.
As more women who have received the initial HPV vaccines enter the screening population, the prevalence of two of three highest-risk genotypes – HPV 16 and 18 – have declined. This is good news and indicates the effectiveness of the primary prevention vaccination.
The not so good news: HPV 31 remains prevalent.
HPV tests with extended genotyping, meaning tests that can individually identify high-risk genotypes, allow for a more precise way than a pooled high-risk assay to measure risk for developing cervical pre-cancer and cancer. Genotyping refers to using the differential risk posed by individual genotypes to stratify a woman’s risk for cancer or pre-cancer and give personalized recommendations.
The three genotypes that pose the highest risk for cervical pre-cancer are 16, 31, and 18. HPV 16 and 18 are currently used in many regions and countries as part of partial genotyping to triage HPV-positive results in order to improve risk discrimination for cervical cancer and pre-cancer. However, HPV31 has been shown to have a risk high enough (equal to or greater than HPV18) to justify a colposcopy referral and may improve identification of at-risk women.
Using HPV tests with extended genotyping, such as the BD Onclarity™ HPV Assay, has the potential to positively impact public health as it enables clinicians and patients to better understand the high-risk genotypes that contribute differently to disease outcomes. The BD Onclarity™ HPV Assay is the only FDA-approved HPV assay with extended genotyping that individually identifies HPV 31, which allows clinicians to identify a patient’s risk more precisely for developing cervical pre-cancer and cancer.
All other FDA-approved HPV assays only provide partial genotyping, which means they only report 16 and 18, or 16 and 18/45, as a group. Other HPV assays report the rest of the high-risk HPV genotypes in a single, pooled result, which may mask the true risk of the disease. By reporting six high-risk HPV genotypes individually, including HPV 31, the BD Onclarity™ HPV Assay with extended genotyping is a more precise, accurate way to measure a woman’s risk for developing cervical precancer and cancer.
Cervical pre-cancer and cancer result because an HPV genotype infection persists for a period of years. The majority of the time, the body’s immune system clears an HPV infection. But same genotype persistence is a warning flag of higher risk of developing pre-cancer. An HPV assay with extended genotyping, like BD Onclarity, can identify same genotype persistence. Simply having a positive HPV test at follow-up could be wither a new infection (low-risk scenario) or a same genotype persisting (high-risk scenario). Using an extended genotyping assay on the first and second occasions allows this important distinction to be made.
The BD Onclarity™ HPV Assay with extended genotyping runs on the fully automated BD COR™ PX/GX System, which integrates robotics and sample management software. This technology enables high-throughput labs to improve and standardize the quality of diagnostic test results by automating laboratory workflow otherwise run by technologists from sample to test result. With unhindered system processing, multiple technologist interactions are no longer necessary, therefore reducing the chance of human error. And for smaller to medium volume labs, the BD Onclarity™ HPV Assay with extended genotyping can run on the BD Viper™ LT.
Clinicians and patients now have the opportunity to shape the future of cervical cancer screening by identifying HPV 31 and other genotypes with an HPV test that offers extended genotyping. Position your practice at the forefront of cervical cancer screening by more precisely identifying a woman’s risk for developing cervical pre-cancer and cancer. Ask your lab to offer the BD Onclarity™ HPV Assay, the only FDA-approved HPV test that individually identifies HPV 31.
Dr. Jeff Andrews is Vice President of Medical Affairs for Integrated Diagnostic Solutions at BD where he has focused on molecular diagnostics, the prevention of cervical cancer through early detection of cancer precursors, and on novel approaches to the diagnosis of infectious diseases in women. A board-certified obstetrician and gynecologist, Dr. Andrews previously served as the chief medical research advisor for the American Society for Colposcopy and Cervical Pathology and is a former professor of Duke University Medical Center and of Vanderbilt University Medical Center. For more information, visit cervicalcancer.bd.com.