Encouraged by the development of rapid at-home coronavirus tests, medtech companies are now betting on the potential to sell over-the-counter and direct-to-consumer diagnostics for diseases beyond COVID-19.

The pandemic has enabled consumers to get tested for the virus in the privacy of their homes, a convenience that companies like Abbott Laboratories and Quest Diagnostics are hoping will appeal to people when it comes to other diagnostics.

Home testing was already rising worldwide, as consumers take a more proactive role in their healthcare. COVID-19 is likely speeding that shift, analysts and companies say.

"Home testing and home collection will fundamentally reshape the diagnostics industry and healthcare in general by providing more testing options," said William Blair analysts, who contend that OTC tests will be one of the key long-term impacts of the pandemic on the industry.

Abbott last week announced it began shipping its over-the-counter BinaxNOW COVID-19 Ag Self Test to retailers, including CVS Pharmacy, Walgreens and Walmart. However, the company has set its sights on a broader at-home testing market.

CEO Robert Ford told investors last week Abbott is looking to bring rapid self-testing to the masses that extends beyond coronavirus diagnostics. Ford envisions an "accelerated" move from "more hospital lab-based testing to more rapid testing outside of that environment where consumers and people can get their results at a much faster rate and, quite frankly, with a little bit of less hassle."

Ford is positioning BinaxNOW as a model for "seeding" the consumer at-home test market and building new testing channels for other ailments that don't have to be performed at a hospital, physician's office or pharmacy.

"Being able to have access to fast, affordable and digitally connected testing is something that I think is going to be here, and here to stay, whether it's a COVID test or other tests. I think that is a change in the delivery, at least in the diagnostic side," Ford said.

Quest estimates consumer testing to be a $2 billion opportunity by 2025, growing at a 10% compound annual growth rate. The lab giant is expanding its existing direct-to-consumer operation to try to capture $250 million of this post-pandemic emerging market.

CEO Steve Rusckowski contends the market is at "an inflection point" due to COVID-19 when it comes to delivering healthcare in new ways. "We have invested in the past and will continue to invest going forward...in the direct-to-consumer opportunity that we see in our space," Rusckowski said at Quest's investor day last month. 

Cathy Doherty, senior vice president for clinical franchises and marketing at Quest, noted that payers are seeing the value, which could spur growth.

"Health plans are now covering consumer-initiated testing for COVID-19," Doherty said. "If health plan support were to expand beyond COVID, this could also be a catalyst for the market to be even bigger."

Quest plans to expand its home kit collection offering by shipping InSure ONE fecal immunochemical tests directly to consumers to go after the colorectal cancer screening market dominated by Exact Sciences' Cologuard. 

"With the pandemic, we do see a catalyst that will accelerate the opportunity in front of us," said Quest's Rusckowski. 

Regulatory uncertainty

Despite the potential for a home testing bonanza, test developers will need to get diagnostics authorized using traditional premarket review processes to support post-pandemic use. 

FDA has granted emergency use authorizations to four over-the-counter home COVID-19 antigen tests and two prescription antigen at-home tests, as well as two OTC molecular tests and one molecular prescription at-home test. There are also 49 molecular EUAs and one antibody authorization that can be used with home-collected samples.  

Looking beyond COVID-19, there are many areas of testing that FDA considers important, including at-home tests, according to Toby Lowe, CDRH's associate director of the Office of In Vitro Diagnostics and Radiological Health.

"Right now, we have a lot of questions and not a lot of answers yet. But some of these areas include home collection and testing," Lowe said earlier this month during a Food and Drug Law Institute webinar on the impact of COVID-19 on the in vitro diagnostics industry.

Lowe added that FDA is "looking to consider how we can expand [home-collected samples and home testing] to other test areas, what might some of those impediments be, and how we can resolve them." 

Specifically, Lowe said the agency is assessing whether specimen types such as saliva, authorized for SARS-CoV-2, are also useful test samples for other respiratory diseases and different kinds of diseases.     

BioFire Diagnostics last month became the first company to win a full FDA marketing authorization for a COVID-19 test, with their granted De Novo request clearing the way for subsequent applicants who can demonstrate substantial equivalence to BioFire's PCR-based respiratory panel through the 510(k) pathway.

"We have authorized the first test for marketing beyond the public health emergency with the BioFire De Novo," Lowe said during a virtual FDA town hall meeting earlier this month.

"That does open up the 510(k) pathway for other molecular diagnostic SARS-CoV-2 tests both individual or a single analyte SARS-CoV-2 test as well as multi-analyte panels, which the BioFire test is. But that De Novo does not impact any other EUA."

EUAs for all other products are set to expire when HHS determines the circumstances that justified the U.S. public health emergency declaration no longer exist. While Lowe said that FDA can't anticipate when the PHE in response to COVID-19 will end, she said the agency is working on a transition plan for devices that are offered under EUA.

Nonetheless, Craig-Hallum analyst Alex Nowak is optimistic about the future of post-pandemic home testing, not just for SARS-CoV-2 but for other diseases.

"Previously tests were confined to the hospital and physicians' office. With the pandemic, diagnostics are in more locations than ever. We expect all diagnostic companies will use the OTC COVID approval as a beachhead and successful implementation may lead to OTC tests for flu, strep, potentially STDs, GI and Lyme, among others," Nowak wrote in a note earlier this month.

At-home tests in particular are a "game changer" for the diagnostics industry, according to Nowak.

"Tests can be stored next to the Band-Aids and tested when exposed to positive cases, or symptoms emerge from any number of pathogens (COVID, other coronaviruses, flu, enterovirus, rhinovirus, etc.)," the analyst wrote.