By Deborah Borfitz
July 8, 2021 | A “silver lining” of COVID-19 is that it has ushered in a new era of diagnostic innovation within test manufacturing facilities and clinical and public health laboratories, producing in 18 months what would be a decade’s worth of progress in non-pandemic times, according to Matthew Binnicker, Ph.D., director of clinical virology at the Mayo Clinic with multiple appointments in the department of laboratory medicine and pathology.
Near-universal focus on one common problem created new ways to work together, overcome gaps in resources, and develop novel point-of-care (POC) testing methods under intense time pressures, as will be explored in a panel session facilitated by Binnicker during the Next-Gen Dx Summit Aug. 24-26. This session will include presentations by Esther Babady, Ph.D., head of the clinical microbiology service at Memorial Sloan Kettering Cancer Center (innovations specific to clinical labs); Benjamin Pinsky, M.D., Ph.D., medical director of the clinical virology laboratory at Stanford (advances in laboratory diagnostics); and Alex Greninger, M.D., Ph.D., assistant professor of laboratory medicine at University of Washington (new POC technologies)—collectively providing a glimpse into the future of diagnostics for infectious diseases.
At least four pandemic-inspired changes are likely to stick over the long term, says Binnicker. Clinical labs and test manufacturers, which significantly increased the number of emergency use authorization applications filed with the U.S. Food and Drug Administration, will almost certainly continue to work more collaboratively with the agency.
Interest in near-patient testing technologies and assays will also remain high, he adds, and not just for COVID-19. Rapid, home-based diagnostic tests for sexually transmitted infections may also become more readily available at local pharmacies with or without a prescription.
“We have created this pipeline where we now have a predicate approach that can be used for other diseases,” says Binnicker. People who may have been exposed to herpes, syphilis, or gonorrhea would appreciate the convenience of being able to self-test at home as have people potentially exposed to COVID-19.
Growing in parallel with POC testing devices during the pandemic was utilization of at-home collection methodologies, where individuals send their self-collected samples in for testing, which Binnicker expects will be the “wave of the future.” Adoption of remote sampling soared after it became a SARS-CoV-2 exposure-avoidance tactic, making it the safer as well as the more convenient option for people.
Widespread use of genomic sequencing to detect variants of the virus circulating across the world has also generated a surge of resources for labs able and willing to add the methodology to their testing arsenal, he continues. “I think we will see more labs performing genetic sequencing than we would have in the absence of the pandemic.”
The changes are mostly positive, although the influx of at-home POC tests has some potential downsides that will need monitoring, Binnicker notes. Whether the tests yield results on par with the performance of lab-based tests, and whether patients can collect samples as effectively as their healthcare provider, remains to be seen.
Individuals purchasing a COVID-19 antigen test over the counter and observing a negative result may not understand that they are not 100% in the clear, he offers as an example. “It just means at that particular moment in time, there wasn’t a high level of viral antigen in the sample.”
As more home-based, POC tests are developed, it will be important that they have the kind of built-in redundancies as lab-based molecular tests for COVID-19, says Binnicker. SARS-CoV-2 molecular tests that have commonly been used during the pandemic were designed to look for multiple parts of the viral genome, so if mutations are present, the tests have a higher chance of detecting any variants.
Pandemic Themes
During the pandemic, the lab community has really “stepped up to the challenge” of having to pivot on an almost daily basis, says Binnicker, who was steeped in those realities at Mayo Clinic Laboratory as vice chair of practice. “One day it was a shortage of pipettes, the next day it was a shortage of test reagents, and the day after that it was an instrument being unavailable. Our laboratories were constantly having to adapt on the fly.”
Labs worldwide “were all racing for shared resources … [which] weren’t unlimited, so the supply chain issues became a real struggle,” he says. For the Mayo Clinic, collaboration with state public health labs was continual. “There were days when they were running out of reagents and we were shipping them what they needed, and vice versa, and they were sharing samples with us to help validate tests.”
The pandemic also necessitated collaboration across clinical labs, as well as sharing about what was and was not working, says Binnicker. “I have never experienced anything quite like it.”
Binnicker says he is a bit more pessimistic about whether open science will be as enthusiastically embraced post-pandemic as it has been amid the public health emergency. The level of willingness to share data and experiences has been unprecedented and provided lessons for responding more quickly to future pandemics—including finding ways to share information more broadly and get tests to more labs earlier in the outbreak.
Once COVID has been conquered, he says, “I am guessing that many will revert back to the pre-pandemic state of things and be more protective of information. But I am hopeful that some sense of that collaboration and teamwork will continue in the future, and I think it will, especially among groups that have … witnessed the benefits of that approach.”
Editor’s Note: Matthew Binnicker will be the featured speaker at the session, “A Silver Lining: The COVID-19 Pandemic Ushered in a New Era of Diagnostic Innovation,” on the Advanced Diagnostics for Infectious Disease track at the Next-Gen Dx Summit on Wednesday, Aug. 25.