Becton, Dickinson and Co. (BD) has received a green light for a premarket approval supplement from the U.S. FDA for an expanded version of its BD Onclarity HPV assay. It includes the expansion for genotype reporting beyond human papilloma virus (HPV) genotypes 16, 18, and 45.
"With this FDA approval, BD can now offer laboratories, clinicians and patients access to critical information in screening for cervical cancer in the [U.S.] and other countries recognizing the PMA supplement or CE mark," said Dave Hickey, president, integrated diagnostic solutions at BD.
Molly Broache, medical science liaison at BD Life Sciences-Integrated Diagnostic Solutions, told BioWorld that the CDC has classified HPV as the most common sexually transmitted infection. Further, while some genotypes are low risk and cause warts, others can cause cancer.
“The International Agency for Research on Cancer (IARC) classifies 13 of these HPV genotypes as high-risk for cancer (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 59, 58, and 68), all of which are included in the BD Onclarity assay,” she added, noting that it is available to customers now.
She continued that the persistence of these high-risk genotypes is tied to almost all cases of squamous cell and adenocarcinoma of the cervix, the two most common types of cervical cancer.
The need for expanded HPV genotyping for cervical screening has been recognized since 2016, and the April publication of the American Society for Colposcopy and Cervical Pathology risk-based management consensus guidelines anticipated that extended genotyping would be introduced soon.
Seeing a shift
According to the PMA supplement, the test specifically identifies certain types and reports the other high-risk HPV (hrHPV) types in groups. It is indicated for use for routine cervical cancer screening per professional medical guidelines.
The Franklin Lakes, N.J.-based company reported the submission last November. At the time, it said that the prevalence of HPV genotypes 16 and 18, which are among those targeted by vaccines, are decreasing in vaccinated populations. As a result, there is a shift in the prevalence of cervical precancer cases to other HPV genotypes.
It backed its submission with data collected during a three-year follow up of subjects from a prospective, multicenter clinical trial conducted in the U.S. that included more than 33,500 women. It included those who received HPV vaccines and those who did not.
When asked about the potential for adding more genotypes, Broache noted that only high-risk genotypes should be reported for clinical use, according to a host of health authorities across the globe. "It is very unlikely that new genotypes will be identified by IARC as high-risk and so there is no current plan to modify the assay by adding more genotypes.”
With that said, this genotyping extension can boost patient care and reduce health care costs by introducing a personalized, risk-based approach to cervical cancer screening. “By identifying which HPV genotype a woman is testing positive for, patients can avoid the immediate need for additional diagnostic procedures (i.e., colposcopy). These additional diagnostic procedures can be both costly to the health care system and unpleasant and stressful for the patient,” Broache added.
On the flip side, those who do test positive for a high-risk genotype can be directed toward diagnostic procedures. Doing so quickly can help women get treated faster and avoid the costs of treating invasive cervical cancer.
Looking more broadly at women’s health, BD long has been involved in pap testing. In August 2018, the U.S. Preventive Services Task Force (USPSTF) issued a final recommendation on cervical cancer screening. Its previous draft proposal included a change to screening techniques for women between the ages of 30 and 65 by recommending cervical cancer screening every three years with pap testing alone or every five years with hrHPV tests as a stand-alone screening option. That appeared to mean replacing co-testing in favor of HPV only.
That could have hit BD and Hologic hard, as they dominate that market, as William Blair’s Brian Weinstein noted at the time. "The final recommendation does, for the first time, list hrHPV as a stand-alone option but keeps the idea of co-testing alive as that is also a recommended option. While we suspect that the primary hrHPV testing path will gain some momentum, especially if the American College of Obstetricians and Gynecologists updates its recommended language at some point, we see this final USPSTF statement as largely positive for BD and Hologic given their core cytology business should remain mostly intact for now,” Weinstein wrote.
Neumodx Molecular also got good news on the HPV front with its report this week that it had scored the CE mark approval for its molecular diagnostic test, which was developed in collaboration with Self-screen BV, of Amsterdam.
The test specifically identifies HPV 16 and 18 while concurrently detecting the other 13 common high-risk types at clinically relevant infection levels.