COVID-19 has driven an uptick in healthcare delivery approaches like telemedicine and point-of-care, home, and direct-to-consumer testing, a shift that some observers believe could continue to accelerate even after the pandemic is over.
It is a trend that has a potential downside for traditional labs as increased POC and DTC testing could cut into their business. It is also, though, a pattern that fits with the industry's move even pre-pandemic toward more patient-centered models of testing and sample collection and one that some in the business suggest could ultimately expand the overall demand for testing.
During a recent 360Dx roundtable on the post-vaccine testing landscape, Nathan Ledeboer, medical director of clinical microbiology and molecular diagnostics at Froedtert Hospital and the Medical College of Wisconsin, said that he believed that the shift to at-home testing and self-collection "precipitated as a result of COVID is going to fundamentally reshape the diagnostics industry and healthcare in general," and added that he thought this reshaping would prove to be one of the major impacts of the pandemic.
His fellow panelists, Elizabeth Marlowe, senior scientific director and head of R&D for Quest Diagnostics Infectious Disease, Mara Aspinall, professor of practice at Arizona State University, and Kelly Wroblewski, director, infectious disease at the Association of Public Health Laboratories, were largely in agreement with Ledeboer's comments.
At the American Clinical Laboratory Association's annual meeting in March, panelists discussing trends in the lab business likewise predicted an increase in at-home testing and self-collection, with, for instance, Dorothy Adcock, the chief medical officer and senior VP at Laboratory Corporation of America, saying that COVID-19 was driving a "paradigm shift" toward home testing.
Speaking recently to 360Dx, Jay Wohlgemuth, chief medical officer and physician executive at Quest Diagnostics, echoed these sentiments, saying that he was "in total agreement that the pandemic accelerated a focus on what I would call consumer-centric care."
A consumer-centric model, he said, "says that the first place testing and engagement with healthcare should be done is in the home, and then if you can't get it done in the home, maybe you go to a community-based location like a patient service center or a Walmart. And then you go into the hospital or health system when you really need an intervention."
Wohlgemuth said Quest was "investing heavily in home-based self-collection kits with telemedicine services." He noted that the company recently inked collaborations with the telemedicine firms Catapult Health and 98point6 that incorporate self-collection for lab testing as part of employer-sponsored health screenings.
"We've certainly seen overall market trends that show us that people want us to meet them where they are at," said Greg Bokar, general manager of point-of-care testing at Opko Health subsidiary BioReference Laboratories.
"What we've learned through the pandemic is that people want flexibility, they want convenience, they want things to come to their house," said Natalie Cummins, chief commercial officer at BioReference. "And so what we believe is that the trend toward convenience even post-pandemic is going to continue."
With that in mind, BioReference launched in January its Scarlet Health product, a digital platform that allows patients to schedule phlebotomy or other specimen collection services at their home or office. Home and concierge phlebotomy services are nothing new and are widely available. Cummins, however, indicated that BioReference believes such services could move from being relatively niche offerings to a commonly used approach for sample collection.
"We believe we can be efficient and it will offer people flexibility with this mobile alternative to having to go to the bricks-and-mortar service center," she said. "We believe that the Scarlet model is really going to be the model that is in demand as we are coming out of the pandemic."
In 2019, Northwell Health Labs launched a mobile app called LabFly that similarly allows users to schedule home or workplace sample collection and then view their lab results. The service costs $20 per visit and is available throughout Northwell Health's service area of New York City, Long Island, and Westchester County. Northwell now plans to market the app to outside health systems, said Mike Eller, assistant VP of business development at Northwell Health Labs.
He said the system developed the app as a way to provide better sample collection coverage for its patients without having to build new service centers in the expensive New York City real estate market.
"We think this is going to be part of our arsenal moving forward," he said. "We would like to start to really integrate more with telemedicine and provide physicians and patients with solutions where they can basically have their healthcare done at home."
Laboratories, especially large national labs, have for a number of years been focusing more on patient convenience in response to factors including increased interest in wellness and health monitoring applications and a need to compete for consumers as health insurers moved away from exclusive lab contracts.
Quest and Labcorp both launched consumer-initiated testing services—QuestDirect and Pixel by LabCorp, respectively—in late 2018. BioReference launched a consumer-initiated service, Mylabology, in 2019.
Smaller labs have also been moving into the direct-to-consumer test market, with SARS-CoV-2 testing accelerating their entry into this part of the testing business.
In an interview last year, Joe Nollar, assistant VP of product development at San Diego-based revenue cycle management and lab informatics firm Xifin, said that he saw the COVID-19 pandemic add to the demand for DTC testing and direct-to-patient reporting of test results that has been building in the industry for years.
"The market is obviously trending toward offering a lot more direct-to-consumer testing," he said. "The last few years, some of our clients have been doing direct-to-consumer testing for carrier screening or genetic health risks and pharmacogenetics, and I think that it is definitely expanding into more routine testing."
With DTC testing and home sampling, labs are still in the loop, as these tests are ultimately done in a traditional laboratory. True at-home testing, however, could conceivably cut into the lab business. Such a dynamic appears to be in effect currently with regard to SARS-CoV-2 testing, where volumes for lab-based molecular testing have dropped significantly in recent months while rapid antigen testing sales are on the rise.
Jon Harol, founder and president of Holly Springs, North Carolina-based lab consulting firm Lighthouse Lab Services, said that home tests could "eat into certain lines of [traditional lab] testing."
He said, though, that he believed home tests are more likely to take advantage of new and expanding demand for testing than displace traditional lab tests.
"I think it creates a bigger pie," he said. "Traditionally, people have gone in and gotten their physical once a year and run a lot of panels. But people do want more data, and if there is an easy way to monitor some of their levels more frequently than that, I think there is definitely a portion of the population that would do that, even if it is at a cash expense."
"But I don't think it's like a one-for-one where if they test at home they are not going to go get their physical or something," Harol added. "I think just that more testing will happen."
BioReference's Cummins said that the company expected increasingly available home and POC testing would primarily attract patients who historically had not done regular lab testing.
"We look at the population who might receive a point-of-care test as an additional population to the group that is being tested in the laboratory," she said. "We don't necessarily see a shift on the point-of-care side from the work that is coming into the laboratory, whether that be [sexually transmitted infections] or [gastrointestinal] or respiratory. We look at it as a population that maybe historically didn't pursue care."
Cummins said, though, that while BioReference doesn't see home and POC testing as cutting into its traditional lab business, the pandemic has pushed it to move into the POC space.
"Prior to the pandemic, point-of-care testing honestly wasn't even a part of our portfolio, and I would say that [was true of] probably many laboratories out there," she said.
BioReference has incorporated POC rapid testing as part of its COVID-19 strategy, particularly for screening applications, an area where BioReference has been particularly active, having established relationships to do surveillance testing for sports leagues including the National Football League, the National Basketball Association, the Women's National Basketball Association, Major League Soccer, the National Hockey League, and Major League Baseball.
On the company's Q1 call, BioReference's executive chairman, Jon Cohen, said it has performed 270,000 COVID POC tests to date and is working to rapidly expand its POC testing capacity.
"Point-of-care devices are expected to play a larger role in COVID testing," he said. "We have validated multiple point-of-care platforms and have developed proprietary software to deliver the report result in a timely fashion in order to provide customized solutions for many different industries."
Cummins said the pandemic has also opened the company's eyes to the possibility of using POC testing for other disease states and "the valuable role it can play in healthcare in general."
Bokar said the company's experience partnering with what he called "nontraditional medical providers" like the NBA and others had led it to begin exploring other nontraditional settings like college campuses and travel hubs where it could offer POC testing.
"It's an area where we don't necessarily believe there is as much testing as there could be, so there is an opportunity to open up an additional market," he said, citing, as a potential example, providing rapid POC STI testing on college campuses.
"I think we will really tether to what the true benefits of point-of-care are and find use cases that best answer to those, but I think without a doubt we believe that point-of-care testing will be something that will continue to grow in the market as consumers really demand to be met where they are at."
Quest is already one of the country's largest POC test providers, offering such testing out of its 160 rapid response labs, Wohlgemuth said.
He indicated that the company would also consider entering the home testing market, noting that, if in the future it sees value in delivering in-home POC testing, "then we will absolutely provide that service as a part of what we do."
He added, though, that "oftentimes the value of having an immediate result is not so large. The value is having the result and then having a telemedicine visit or physician help you interpret it."
"But we're very open to providing as part of our services home kits that including point-of-care testing," he said.
This story first appeared in our sister publication, 360Dx, which provides in-depth coverage of in vitro diagnostics and the clinical lab market.