NEW YORK – With the recent approval of Becton Dickinson's human papillomavirus test for use with self-collected cervical swab samples, MD Anderson researchers and the Texas-based federally qualified health center Su Clinica are embarking on a pilot program to evaluate implementation of the assay.
The firm's BD Onclarity HPV Assay first received CE marking in 2014 and US Food and Drug Administration approval in 2018 for use with clinician-collected swab samples. More recently, it was cleared for use with self-collected samples collected in a healthcare setting by both the FDA and Health Canada.
In addition to BD's test, Roche received FDA approval for use of its HPV test with self-collected samples in May.
According to Jeff Andrews, BD's VP of global medical affairs for diagnostic solutions, regulatory approval of HPV tests using self-collected samples opens a pathway to reach patients who were previously unscreened or under-screened.
The qualitative PCR-based assay is intended for the detection of HPV and extended genotyping of the virus, which is performed to help with the identification of 14 virus types, including those connected with high risk of cervical cancer and precursor lesions.
One of the "logical places to first use this new opportunity" is in federally qualified health centers, which often see patients who are uninsured or underserved, Andrews said. Using the test with self-collected samples at Su Clinica will provide not only a way for patients at the health center to be screened but also a chance for BD to study implementation and report on the lessons learned so it can be scaled up across the US.
The five-year study is being funded by a $2.5 million grant from the Cancer Prevention and Research Institute of Texas.
Su Clinica was chosen because it is in a county that has a relatively high incidence of cervical cancer and a large number of patients in the eligible cervical cancer screening age group who don't have insurance coverage or may face difficulties receiving healthcare, Andrews noted. Many federally qualified health centers do not have an Ob/Gyn in the office every day who can do speculum exams and gather cervical swab samples, so they are ideal because whenever an eligible patient shows up, they could be offered the chance to self-collect their sample, he added.
Su Clinica CEO Elena Marin said that some of her community health centers only have internists and family medicine clinicians, so doctors generally refer patients to their integrated women's health centers for a pelvic exam. However, "seeing an internist and referring a patient doesn't necessarily mean that they're going to actually show up for their test," she said.
Most internists at her facilities don't have time for a pelvic exam because they are managing multiple other chronic illnesses and medications, so cervical cancer screening is not a priority, Marin said, adding self-collection of samples to bypass the need for a pelvic exam will be a "game-changer."
Self-collection can also help reduce the number of visits to different doctors' offices, which is important because many patients don't have the time for another visit or don't have transportation options. A second visit to another doctor is "one of the things that we want to reduce and eliminate," she added.
According to Andrews, the top reason for low screening rates is a lack of awareness. In addition, fear of receiving a speculum exam due to pain or past trauma can contribute to patient hesitancy about clinician collection of cervical swab samples, while facilities that don't have the providers or the space to conduct the exams are unable to collect these samples. Providing a new way to be screened will help all patients who haven't previously been screened and will allow for faster and easier sample collection.
"You can imagine how much quicker you could do a self-collection … than putting someone in a room, having them disrobe, have someone come in [to] do the exam, etc.," Andrews said.
The study is being conducted because there are "usually hiccups when you're implementing something" new, he noted. The pilot study will demonstrate to other federally qualified health centers how best to implement self-collection. Facilities will have to make adjustments to their electronic health records to trigger a test order, that order must trigger the correct laboratory code, and the test kit must be sent out and then returned to the laboratory. The implementation study is intended to make sure all of these steps run smoothly.
In addition, the study — which Marin said is expected to start in December — will also include the downstream arrangements that must occur after a positive test result is received. For patients who are asked to come back for further testing, Andrews said they will be looking at how many patients returned, how hard it was to reach them, and what communications worked best.
Marin noted that Su Clinica's goal for the study is to achieve a screening rate of 90 percent. Right now, the center is screening between 70 percent and 80 percent of eligible patients, she said.
This study is another step toward BD's ultimate goal, which is at-home sample collection in the US, Andrews said. The firm first began communicating with the FDA and National Cancer Institute in 2019 about home sample collection and was prepared to start a validation study in 2020, but that was put on hold due to the COVID-19 pandemic. Currently, the company is involved in a National Institutes of Health-funded trial that will be used in part to validate BD's test for at-home self-collection to satisfy FDA requirements, Andrews said.
The company is also performing its own analytic studies to supply additional information about the stability and usability of the test for at-home collection and is "actively working" on the indication, Andrews added.
This is "just the start of a very impactful diagnostic tool to be used in different arenas and places that will make it easier and simpler for women to have access to cervical cancer screening," Marin said.