As home Covid-19 tests increased, so did the demand for other tests.

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Ellume has received emergency use authorization to sell his over-the-counter Covid-19 home test. Photo credit: Ellume

The Covid-19 pandemic has given people a taste of home testing, with insurers required to cover tests performed at both drive-thru and home-based sites, with or without a prescription.

Now, companies are betting on a wider increase in home diagnostics, as people become more familiar with virtual visits and seek more home care.

Preventive tests, such as mammograms and colonoscopies, fell sharply in the first weeks of the pandemic. Although they have started to rebound, many patients are still undiagnosed or have to wait for office visits.

“Everyone is so focused on Covid testing. The other things don’t go away, you know? The diabetes hasn’t gone away, the colon cancer isn’t gone, ”said Peter Foley, CEO of LetsGetChecked. during a MedCity INVEST panel. “We are seeing a massive drop in the number of tests being done in 2020 and there is a consequence to that.”

To fight against this, several insurers have sent home colon cancer screening kits to patients who had to take their exam. Although they work as an initial screening for low risk patients, they are still not as effective as a colonoscopy.

Last month, Quest Diagnostics rolled out a similar type of home screening. The company made its first bet in consumer-led testing long before the onset of the pandemic, when it launched a home STD test in 2019.

Quest expects to generate $ 250 million in revenue from home testing by 2025. Including Covid-19 testing, that number could be eight times higher.

“What’s interesting now is that the health plans also cover consumer-initiated testing for Covid-19,” Cathy Doherty, senior vice president of clinical solutions for Quest, said in an interview. “Before the pandemic, I don’t think anyone would have imagined a health plan that paid for a consumer-initiated test.”

Julia Cheek, CEO of home testing startup Everlywell, has also been closely monitoring insurers’ tenure to cover Covid-19 testing. The Austin-based startup recently obtained approval from the Food and Drug Administration to offer its Covid-19 home test without a prescription.

Initially, some components of home testing were not covered, such as shipping costs or the telehealth consultation Everlywell offers with its tests, Cheek said.

“We were able to learn more about what people need in their plans as this work progressed,” she added.

Interest in the other Everlywell tests has also increased. Cheek said sales of STI test kits have doubled and tests for heart health, HBA1C and women’s health have tripled. Most of its tests are lab-developed tests, which means they are not subject to FDA review, although Everlywell recently obtained an FDA-approved cholesterol test as part of the. a larger acquisition.

As insurers continue to cover Covid-19 tests and a limited number of home screenings during the pandemic, Cheek and Doherty are closely monitoring whether this continues in the future.

“We believe that health plans look at their activities as we look at our activities in this changing landscape,” Doherty said. “Do I think it’s going to be a big brush?” Not necessarily. Do I think it will change? I do.”

Not all tests are created the same
Although more and more people have become familiar with home testing, the pandemic has also highlighted large variations in the accuracy of testing. Research published in Plos One last year found that Covid-19 tests reported a false negative rate of up to 29%, meaning that in the worst case, they could miss 3 in 10 cases.

At first, home testing was limited because it had to use a nasopharyngeal swab, Foley said, which can be more difficult and sometimes uncomfortable. But after researchers demonstrated that a nasal swab or cheek swab could work, they proliferated.

It still took some research to figure out what works best to achieve an accurate result without supervision. For example, Cheek said Everlywell found it would be easier to use a nasal swab instead of a saliva swab for their home testing kits. The saliva swab forces people not to eat, drink or brush their teeth one hour before the test.

“Things that sometimes seem easier for consumers are not necessarily easier,” she said.

Now the FDA is placing more emphasis on over-the-counter tests and devices where users can receive their results at home.

Home testing start-up Ellume was awarded a $ 232 million contract from the Department of Health and Human Services in February to manufacture more of its rapid home antigen tests. Users put a swab in an analyzer to get the result at home, instead of mailing it to a lab.

Other startups, like Cue Health, are developing similar technology for home flu testing.

Sean Slovenski, CEO of diagnostics start-up BioIQ, expects a “groundswell” of routine diagnostics to make up for time lost during the pandemic. He sees an opportunity for completely at-home testing to fill in the gaps, removing overwhelmed labs completely from the equation.

“For some tests, this will take place in the next few months. For other tests, this will take place in the next few years, ”he said. “Before Covid, it would have taken a decade or so for much of this to happen.”

In the meantime, people face an almost overwhelming amount of choice when it comes to testing, Covid or whatever. Slovenski compared it to the early days of WebMD and other healthcare websites, when patients walked into the office after “diagnosing” themselves.

“We’re going to see some of that here too. It will take time for people to be diagnosed at home and know what is good, not good, right or wrong, “he said. “How do you associate telemedicine with this? It looks a lot like this overwhelming wild west.



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