NEW YORK ─ At-home, in vitro diagnostic tests being developed to detect and differentiate COVID-19 and influenza may be what physicians need to enable optimal treatments during the next flu season and beyond, but numerous challenges need to be conquered before the tests can accomplish broad adoption, according to some IVD industry experts.
Firms such as Lucira Health, Visby Medical, and Cue Health have announced that they are developing combination tests that detect both COVID-19 and flu on their current COVID-19 testing platforms. They are running clinical validation trials for combo tests that would sidestep sending samples to a laboratory and waiting for results. If the tests become available, people could use them to report results to their physicians, with the aim of rapidly receiving a prescription and treatment that could be crucial to stemming either flu or COVID-19.
According to some experts, such tests could enable efficient test-and-treat programs, a concept introduced by President Joe Biden in March that aims to provide patients with new antiviral medications when a virus is detected early.
"We're entering a new era with a focus on giving Americans the power and responsibility to test themselves at home," said Mara Aspinall, professor of practice at Arizona State University's College of Health Solutions and a consultant with COVID-19 Response Advisors. "Because of COVID, we know that people have the ability and interest to do it."
An anticipated increase in the prevalence of flu could increase demand for the combo tests. In the recent 2021/2022 flu season stretching approximately from September 2021 through March 2022, the number of flu cases grew from the previous flu season, which was exceptionally mild largely because of COVID-19-related lockdowns and more widespread use of masks. Though the increase in cases during the recent flu season was "not dramatic … we think that there will be a lot more flu, now that people in general have stopped wearing masks," Aspinall added.
According to Lucira Health Cofounder and Chief Technology Officer Debkishore Mitra, a combo COVID/flu test done at home has the potential to "speed up the whole process" from test to treatment. "We are lucky to have effective treatments for both flu and COVID, but they are virtually unusable without differentiation," he said.
Emeryville, California-based Lucira is developing a single-use, at-home molecular test to detect and differentiate COVID-19, flu A, and flu B in less than 30 minutes. The company plans to file for Emergency Use Authorization from the US Food and Drug Administration, as well as regulatory approval from Health Canada, the European Medicines Agency, and other regulatory authorities this quarter.
Mitra said he expects regulatory decisions to be completed before this upcoming flu season and that the firm has tested more than 600 samples in numerous locations and is seeing "performance comparable to lab-based PCR assays."
Meanwhile, San Jose, California-based Visby Medical is using funding from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop a 30-minute flu A, flu B, and COVID-19 combo test on a point-of-care PCR platform for COVID-19 and sexually transmitted disease tests.
"The goal is to provide actionable information to people using the combo test at home," said Teresa Abraham, VP of scientific and technical partnerships at Visby. "For COVID and influenza treatments to be effective, you have to use the drug as soon as possible after developing symptoms, and this test will allow that."
The firm intends to first launch its combo test for use in settings such as doctor's offices and urgent care centers, and subsequently release it as a test prescribed by a physician that is completed at home.
If it obtains an FDA EUA, the company anticipates launching the COVID/flu combo test for use in clinical settings before the end of this year. Meanwhile, the prescription at-home test "is on a slightly delayed timeline because we are developing digital assets that will allow automatic interpretation of test results," Abraham said, adding that the firm also expects to pursue 510(k) clearance.
A third Californian firm, San Diego-based Cue Health, is also developing a COVID-19/flu combo test on a platform that it is currently marketing for COVID tests. Cofounder and CEO Ayub Khattak said recently on a conference call to discuss the firm's financial results that it is starting clinical studies for its Flu + COVID multiplex test this quarter. Later this year, the company expects to launch a test-to-treat feature within its digital health platform through which customers will be able to request the delivery of prescriptions to their home within hours in the Cue Health app.
In a nod to the importance of multianalyte respiratory tests, the FDA this week issued an EUA to Laboratory Corporation of America for its Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.
The Labcorp test detects and differentiates not only influenza A, influenza B, and SARS-CoV-2 but also respiratory syncytial virus (RSV).
But even as firms move forward with plans to develop and commercialize combo tests, some IVD executives see potential barriers to adoption, including reimbursement issues. Will the government and private payors pay for such tests? If not, will individuals pay out of pocket for them?
In the case of Labcorp's test that received EUA this week, the Burlington, North Carolina-based firm said that if a patient meets clinical guidelines and has insurance, there will be no upfront cost for the kit, which can be ordered through the Labcorp OnDemand digital health platform.
Nathan Ledeboer, medical director for molecular diagnostics at the Medical College of Wisconsin, said reimbursement will be "one of the main determinants" of how broadly at-home combo tests are adopted.
"The big question will be whether insurance companies ultimately agree to reimburse for influenza testing in the home, and whether they see a financial incentive [to provide reimbursement]," he said, adding, "If you can go to your prescriber with a test result from which you receive treatment, insurance companies will probably look at that."
Robert Boorstein, medical director of Brooklyn-based Lenco Diagnostic Laboratory, said in an interview he is "not convinced" that at-home COVID/flu combo tests are going to achieve much uptake. People will need to decide that a COVID/flu combo test provides information that is important enough for them to pay for it, Boorstein said, adding, "If the price of a test exceeds $50, it's probably going to have a fairly limited market."
When people experience symptoms indicative of COVID-19 or influenza, they may opt for an inexpensive at-home antigen test to rule out COVID-19 and forgo the purchase of a combo test.
"Like so many new innovations, the [at-home combo tests may] start out being purchased by the wealthiest who can afford it," Aspinall said, adding, "We know there's a small group of people who can afford them, and knowing whether you have flu or COVID is incredibly powerful."
There are other potential adoption barriers.
Ledeboer said it will be important for developers to provide evidence that the tests can be done properly at home. "COVID is suitable for testing in the home partly because almost anybody can collect a saliva or nasal swab sample," he said. "We need to see whether similar levels of sensitivity can be achieved for an at-home combo test using nasal swab collection."
Developers will also need to demonstrate that their testing platforms can provide the same levels of sensitivity for COVID/flu testing as for COVID testing, he said, adding, "We've seen for about a decade that there's a ton of variability in the performance of rapid antigen tests for detection of influenza. That may mean we need molecular tests that provide better sensitivity, unless we can improve the antibodies in lateral flow assays to get a better level of performance."
Lucira Health, Visby Medical, and Cue Health are each working to enable electronic interaction between patients and test and treatment prescribers, and Lucira's Mitra and Visby's Abraham said they expect that the prescribers' organizations will be reimbursed for testing in these circumstances.
However, "for at-home tests, insurance coverage is an evolving landscape," Mitra noted. When consumers purchase the test without a prescription, they will pay out of pocket unless the government mandates coverage by payors, he noted.
Mitra added that he anticipates that the price of Lucira Health's combo test will be similar to that of its current COVID-19 test. On Amazon.com, a Lucira Check It Single-Use COVID-19 Test is currently $75.
When people evaluate the cost of at-home testing, they "need to look at full system cost," Aspinall said. Those who test negative using inexpensive antigen tests but have symptoms tend to take a PCR test for confirmation, driving up demand for such testing in laboratories, she noted.
"PCR tests are $100 right now for the government, and if we have a home test [whether it is based on molecular or antigen technology], it is probably going to be cheaper," she noted.
Further, for both COVID and flu, when individuals can quickly get medication it "dramatically reduces the likelihood" of expensive hospitalizations, which should motivate people to pay for an at-home test, Aspinall added.