At-home tests, once considered an anomaly, became de rigueur and a boon for diagnostic companies during the COVID-19 pandemic.
Now, as COVID-19 testing rates decline from their pandemic peak, these businesses see an opportunity in direct-to-consumer testing, a market that Quest Diagnostics says could total $2 billion by 2025.
“Never before has the general population been more aware of in vitro diagnostics and the relevance of our industry than in the last two years with COVID-19,” Jenna Urquhart, head of new franchise business development for Siemens Healthineers, said in an email. “Thanks to the prevalence of rapid antigen tests, people have learned that it is possible to collect a sample, run a test, and receive results in minutes, all in the comfort of their own homes.”
Four of the largest diagnostics firms surveyed by MedTech Dive said they plan to continue offering COVID-19 testing and will add other types of at-home tests. Some companies said they see an opportunity in detecting other infectious diseases, while others expect increasing demand from patients managing chronic health conditions.
Here’s a summary of their responses:
What at-home tests do they offer now?
Becton Dickinson currently offers its Veritor At-Home COVID-19 Test, a rapid antigen test that was authorized for emergency use by the Food and Drug Administration last year. A pack of two tests costs $37 at CVS.
Siemens Healthineers sells its CLINITEST rapid COVID-19 antigen self-test, which it says can provide results in 15 minutes. A five-pack of tests costs about $35 on Amazon.
Abbott Laboratories’ BinaxNOW rapid antigen tests continue to surpass its expectations for sales. In the third quarter, the company brought in about $1.6 billion from at-home testing alone. A pack of two tests costs $24 at CVS.
Labcorp offers several at-home collection kits, where patients can collect samples at home and mail them to a laboratory for processing. It sells a collection kit for a COVID-19 molecular test, which costs $119, as well as a combination COVID, flu and RSV test for $169. The company also offers screening for other conditions, including an at-home colon cancer test kit and a hemoglobin A1c test to assess diabetes risk. It also sells a rapid fertility test for men.
Public health reporting has been a challenge with some home Covid tests. How are companies handling that?
BD’s Veritor test is one of a few on the market that automates result reporting to federal and some state health authorities, Kamni Vijay, BD’s general manager for point-of-care diagnostics, wrote in an email. Users scan the results into their smartphone and share them with public health authorities. “The app sends blinded [anonymous] test results, by zip code, automatically, to federal and some state health authorities,” Vijay said.
Labcorp: Because all of Labcorp’s COVID-19 tests are processed in laboratories and none are antigen tests, all of the results are reported to public health organizations, Labcorp spokesperson Rachael Roig said in an email.
What’s contributing to the increase in at-home testing?
BD: “We view the move of diagnostic testing to new care settings and closer to the patient as an irreversible force in the healthcare industry, and one that has only been accelerated by the COVID-19 pandemic,” Vijay wrote.
Siemens Healthineers: “Two significant shifts are contributing to a likely increase in at-home testing. First, the pandemic has created greater opportunity and demand across the board for more healthcare applications to occur at home — whether it's telemedicine, teletherapy or at-home testing applications. Second, there is increased interest from patients in receiving test results faster,” Urquhart wrote.
Labcorp: “More and more, consumers are seeking convenience and access across all aspects of their health. We do see a growing at-home demand and will continue to prioritize innovation in this area,” Roig said.
What at-home tests do firms plan to offer in the future?
BD: “Other types of at-home tests for infectious disease are on our roadmap. Those tests include flu and strep, as well as a combination test that can detect and differentiate COVID-19, flu A and flu B from a single nasal swab,” Vijay wrote.
Labcorp plans to continue offering COVID-19 tests for as long as they are needed by consumers and health professionals, Roig wrote. She added that the company is “working on numerous new offerings to help consumers understand their general health and wellness, monitor chronic conditions and screen.”
Abbott also plans to continue offering COVID-19 tests. “We are planning now, while the pandemic is ongoing, our post-EUA regulatory strategy, to include transition from EUA to full FDA clearance,” the company said in an email. “The pandemic has shown the value of at-home testing and sample collection, and Abbott plans to bring that convenience and discretion to additional areas in the future, including for STIs [sexually transmitted infections].”
Siemens Healthineers will continue to support COVID-19 self-testing, and is “exploring opportunities to further leverage the commercial channels created during the pandemic for home use focused applications,” Urquhart said.
Where is the biggest business opportunity?
Siemens Healthineers: “Population growth, an aging population, and the rise of chronic diseases like diabetes will lead to more people looking for convenient healthcare options such as at-home testing,” Urquhart added. “What if we had convenient at-home tests for all different kinds of health conditions — what if we could catch an issue before it gets complicated or worse? As we’ve seen with rapid antigen testing — that’s the biggest opportunity, allowing people to easily, quickly, and inexpensively screen for health conditions to give them peace of mind or catch any issues before they could develop into more serious problems.”
Labcorp also focused on chronic health conditions, noting the company’s goal is to “provide the most accessible testing options, specifically for chronic illnesses and health optimization.” Labcorp is looking to make testing more convenient with mobile phlebotomists who come to patients’ homes. “For individuals wanting or needing to test more frequently, ease of access is crucial and oftentimes difficult,” Roig wrote.