Why rapid coronavirus tests have been slow to be approved

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Rapid at-home COVID-19 tests are fast, but the regulatory approval needed to get them in the hands of Americans has been slow to come.Why it matters: Quick, fully at-home COVID-19 tests could make a vital contribution to stemming the pandemic — and open up a new frontier for more constant disease surveillance — but old assumptions about how diagnostics should be used are holding them back.Get market news worthy of your time with Axios Markets. Subscribe for free.Driving the news: On Wednesday, the Biden administration unveiled a $1.6 billion plan to accelerate COVID-19 testing in schools and other settings, bolster the supply chains for testing materials, and enhance genetic sequencing surveillance.'We still don’t have enough testing, and we don’t have enough testing in all the places it needs to be,' Biden testing coordinator Carole Johnson told reporters.By the numbers: The number of COVID-19 tests carried out per day in the U.S. has dropped by roughly 30% from the peak a month ago.The U.S. has carried out around 340 million tests in total — a little more than one per person over the nearly year-long pandemic.Some of that dip is likely due to declining case numbers. But to advocates of rapid at-home tests, the drop also points to problems in how we use tests — and the kind of tests that have been approved.COVID-19 tests have mostly been used for the purposes of diagnosing people who may be sick, and most of the tests that have been approved employ highly accurate but often labor-intensive PCR methods that require people to travel to clinics.The logistics and costs of manufacturing and running mass amounts of PCR tests make it difficult to constantly screen the population — which is precisely how cheaper, rapid at-home COVID-19 tests could be employed.Context: Pasadena, California-based Innova produces COVID-19 tests that cost less than $5 and work with the ease of an at-home pregnancy test, yielding results in 15–30 minutes. For months, Innova has been sending mil