A deep-dive into how the pandemic turned an evolution into a revolution — and what to expect the future of diagnostic testing to look like.
March 25, 2021
The COVID-19 pandemic affected diagnostic testing much like it did other parts of the healthcare delivery system — it demanded completely novel approaches at some points, and merely accelerated trends underway at others.
In other words, an evolution became a revolution.
That revolution, according to Quest Diagnostics Chief Medical Officer Jay Wohlgemuth, MD, can be categorized by just a few words, most notably “convenience.”
“Anything you can do from your home, you should,” Wohlgemuth said. “Then you should come in to a Quest patient service center or Walmart for the next layer. Then, you would go to your local health system for things you absolutely needed to, like having a baby or getting a knee replaced. That is absolutely a huge trend in the industry. We are investing heavily in home-based self-collection kits which are very consumer-centric and friendly, and then telemedicine services.”
It’s not only long-established entities like Quest that have been preparing for the consumer-friendly testing future. Emeryville, Calif.-based Lucira Health, for instance, was already developing an at-home testing platform, but not for COVID-19.
“Lucira was in the final stages of developing of an at-home flu test kit when the pandemic hit,” Kelly Lewis Brezoczky, executive vice president at Lucira, said. “We quickly realized in early 2020 that the platform we had developed might work for COVID. Lucira’s assay team was up for the challenge and within two months we had a COVID assay ready for clinical testing.”
FDA granted Lucira emergency use authorization for its molecular prescription take-home test in November. FDA Commissioner Stephen M. Hahn said the test, the first self-administered test to receive approval, represented “an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
The at-home testing market accelerated further in December 2020, with EUA approval of Abbott’s BinaxNOW antigen test, available by prescription in tandem with telehealth guidance.
The approvals served as exemplars of a diverse new ecosystem of diagnosis and clinical guidance and also help illustrate how testing experts view a post-pandemic world in which COVID-19 will be with us as an additional respiratory infection that will regularly join others such as flu and respiratory syncytial virus.
New approaches, new defaults
In addition to the trend of enabling widespread at-home testing, the market can also expect two other trends to emerge in the next round of respiratory virus surges — there will almost certainly be a much greater need for tests capable of testing for a variety of illness, and testing for COVID-19 itself will include a pervasive “search for nothing.”
“The future is never certain,” William Morice, MD, PhD, president of Mayo Clinic Laboratories, said. “But most people in the infectious disease expert field feel COVID will probably be something that will circulate through like other respiratory pathogens. So the testing will be with us and I think more than likely will become part of the normal armamentarium of clinical tests for respiratory illness. The vaccine will decrease the amount of testing and it might change the focus of testing, but it won’t obviate the need completely.”
In future surges of respiratory illness, Morice said, it will be highly likely that combination testing for more than one type of virus will become commonplace. Recalling the concern over the 2020-21 flu season that ultimately turned out to be almost non-existent, Morice said it will be natural and normal to have to narrow down what a symptomatic patient may be presenting with.
“In the long view, if somebody comes in with a respiratory illness next winter, there will almost certainly be some need for combination testing,” Morice said.
Numerous developers have received FDA authorization for combination testing. Abbott was the latest to get clearance on March 4, joining platforms by BioFire, GenMark, Roche, Qiagen, and others.
Brian Weinstein, partner and head of life sciences equity research at investment and financial services firm William Blair, concurs with Morice’s contention combination testing will be a necessity, and adds that additional vagaries surrounding how long the vaccines’ immunity lasts, and who has and has not received a vaccine, will mandate an entirely new rationale for testing.
“At the heart of what I think the future of testing for COVID-19 in the post-vaccination world is this — testing will no longer be used to diagnose active infection or tell you you have the disease,” he said. “Instead, the use case is changing and it will be used much more for people who show no symptoms, to clear them.”
Open-ended questions of COVID testing
The novelty of the SARS-CoV-2 virus leaves diagnostics professionals with many ambiguities that will need to be addressed: Who to test? Where to test? When to test? How to test? How much will it cost to test? How will we know who has been tested, and what is their status?
The answers to some of these questions, such as the drive to deliver at-home convenience, often paired with integrated virtual clinical guidance, are clearly emerging in the marketplace. But others, such as settling on whether or not to use antigen or PCR tests, at what price point insurers, providers, and consumers will accept testing at regular intervals, and how data on testing will be integrated into everyday life, are still works in progress.
On one hand, the ubiquity of testing that occurred throughout 2020 when people were symptomatic, or that were mandated as essential workplaces, and later, as schools and universities opened up, produced a society-wide awareness of testing, and probably an appreciation for options that did not entail driving to a central location and waiting for a prolonged period of time.
“Another really important part of this is, just because testing has been made available, there has to be a willingness by an individual to get tested,” Weinstein said. “There will be instances where there will be a gatekeeper, like getting back to work, or if you want to get on a plane or cruise ship. Those are points you may be required to be tested.
“But then there are all the other times where people just have to make the decision — do you want to be tested if you feel fine? And I’m not sure that market will really germinate. That’s still to be determined.”
Weinstein also said trying to set a definitive acceptable price point per test will depend on numerous factors, including the environment the individual being tested will inhabit. A precautionary antigen at-home test for an asymptomatic person will be much less costly than a pre-surgical molecular test, for instance. The CDC has released algorithmic interim guidance for best practices around the less-sensitive antigen tests, and Wohlgemuth said Quest instituted a testing program with Mid-American Conference football teams during the fall 2020 season that employed antigen tests that were confirmed by PCR testing when necessary.