How extended genotyping is reforming cervical cancer screening
The CDC and the American Cancer Society have reported that there are about 14,000 new cases of cervical cancer in the United States each year and about 4,000 deaths. Almost all of these diseases are preventable.
Primary prevention is provided by effective HPV vaccination programs. Secondary prevention is achieved through effective screening programs that detect pre-cancer. HPV is the cause of cervical cancer. The current best practice for screening is called primary HPV screening; meaning HPV – not Pap – is done first, then if that result is positive, further tests follow.
Modern precision medicine includes risk-based screening. When the calculated risk is above a predefined threshold, a particular action is recommended, which may be more testing or treatment. When the calculated risk is below the threshold, watchful waiting may be recommended. For a positive HPV result at screening, WHO and ASCO recommend either cytology or partial/extended genotyping as triage to identify women at high risk of developing cancer or pre-cancer.
Genotyping involves using the differential risk posed by individual genotypes to stratify a woman’s risk of cancer or pre-cancer and give personalized recommendations. The three genotypes with the highest risk of pre-cancer are 16, 31 and 18.
As more women who received the first HPV vaccines enter the screening population, the prevalence of two of the three highest-risk genotypes — HPV 16 and 18 — has declined. This is good news and testifies to the effectiveness of primary prevention vaccination.
The less good news: HPV 31 remains widespread.
HPV tests with extended genotyping, i.e. tests that can individually identify high-risk genotypes, allow a more accurate way than a pooled high-risk test to measure the risk of developing pre-cancer and cervical cancer. Genotyping involves using the differential risk posed by individual genotypes to stratify a woman’s risk of cancer or pre-cancer and give personalized recommendations.
The three genotypes with the highest risk of 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 sort positive HPV results to improve risk discrimination. for cervical cancer and pre-cancer. However, HPV31 has been shown to pose a sufficiently high risk (equal to or greater than HPV18) to warrant referral to colposcopy and may improve the identification of women at risk.
The use of HPV tests with extended genotyping, such as the BD Onclarity™ HPV test, has the potential to have a positive impact on public health because it allows clinicians and patients to better understand the high-risk genotypes that contribute differently to disease outcomes. The BD Onclarity™ HPV test is the only FDA-cleared HPV test with expanded genotyping that individually identifies HPV 31, allowing clinicians to more accurately identify a patient’s risk of developing pre-cancer and Cervical cancer.
All other FDA-approved HPV tests only provide partial genotyping, meaning they only report 16 and 18, or 16 and 18/45, as a group. Other HPV tests report the rest of the high-risk HPV genotypes in a single, pooled result, which can mask the true risk of disease. By individually flagging six high-risk HPV genotypes, including HPV 31, the BD Onclarity™ HPV Test with Extended Genotyping is a more accurate and precise way to measure a woman’s risk of developing precancer and cancer of the cervix.
Pre-cancer and cancer of the cervix result from an infection with the HPV genotype persisting for several years. Most of the time, the body’s immune system clears an HPV infection. But the persistence of the same genotype is a warning signal of a higher risk of developing pre-cancer. An HPV test with extended genotyping, such as BD Onclarity, can identify persistence of the same genotype. Simply having a positive HPV test at follow-up could mean a new infection (low-risk scenario) or the persistence of the same genotype (high-risk scenario). Using an extended genotyping test the first and second time helps to make this important distinction.
The BD Onclarity™ HPV Test with Extended Genotyping runs on the fully automated BD COR™ PX/GX System, which incorporates robotics and sample management software. This technology enables high-throughput labs to improve and standardize the quality of diagnostic test results by automating the lab workflow otherwise handled by technologists, from sample to test result. With unhindered system processing, multiple interactions with technologists are no longer necessary, reducing the risk of human error. And for small to mid-volume labs, the BD Onclarity™ HPV Test with Extended Genotyping can be 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 expanded genotyping. Position your practice at the forefront of cervical cancer screening by more accurately identifying a woman’s risk of developing pre-cancer and cervical cancer. Ask your lab to offer the BD Onclarity™ HPV test, the only FDA-cleared HPV test that individually identifies HPV 31.
Dr. Jeff Andrews is Vice President of Medical Affairs for Integrated Diagnostic Solutions at BD, where he focused on molecular diagnostics, cervical cancer prevention through early detection of cancer precursors and on new approaches to the diagnosis of infectious diseases in women. A board-certified obstetrician and gynecologist, Dr. Andrews previously served as Chief Medical Research Advisor for the American Society for Colposcopy and Cervical Pathology and is a former professor at Duke University Medical Center and Vanderbilt University Medical Center. . For more information, visit cervicalcancer.bd.com.