Rapid tests coming to stores near you
Scientists and lawmakers agree that over-the-counter covid tests could allow desk workers to settle back into their cubicles and make it easier to reopen schools and travel.
But even as entrepreneurs race their products to market, armed with millions of dollars in venture capital and government investment, the demand for covid testing has waned. Manufacturing and bureaucratic delays have also kept rapid tests from hitting store shelves in large numbers, though the industry was energized by the Food and Drug Administration’s greenlighting of two more over-the-counter tests Wednesday.
Corporate giants and startups alike plan to offer a dizzying array of test options, most costing between $10 and $110. Their screening accuracy varies, as does the way consumers get results: collection kits mailed back to a lab, devices synced with artificial intelligence-enabled apps on a smartphone that spit out results within 15 minutes, and credit card-sized tests with strips of paper that must be dipped into a chemical substance.
“At-home tests are one of the key steps to getting back to normal life,” said Andy Slavitt, a member of the White House COVID-19 Response Team, during a February briefing.
The Biden administration announced in March it will allocate $10 billion from the recently passed stimulus package for covid testing to expedite school reopenings, and earlier said it would invoke the Defense Production Act to manufacture more athome tests. Separately, the federal government has already sent millions of Abbott Laboratories’ BinaxNOW rapid tests to states, and California, for instance, is giving 3 million of them to its most disadvantaged school districts for free.
Large employers, like Google, sports leagues and the federal government, have already shelled out millions to regularly test their workers. Amazon just received emergency use authorization from the FDA for its own covid test and home collection kit, which it intends to use for its employee screening program.
Individuals who want to buy over-the-counter tests can bill their health insurance plans, which are required by the federal government in most cases to fully cover covid tests that have been authorized by the FDA.
Everlywell, based in Austin, Texas, is an at-home diagnostic company that already sells its collection kit to consumers through its website and Walgreens, and will soon offer sameday delivery via DoorDash in a dozen cities. Dr. Marisa Cruz, Everlywell’s executive vice president of regulatory and clinical affairs, said buyers can seek reimbursement from their insurance plans for the kit’s $109 cost. The tests are also eligible for purchase with pretax dollars from health savings or flexible spending accounts, she said.
Even with vaccines, epidemiologists say, rapid tests are desperately needed because more testing, along with mask-wearing and physical distancing, will get people back in offices and classrooms and help catch cases that go undetected. A report by the Centers for Disease Control and Prevention found that, of people with active infections, 44% reported no symptoms.
But the market for overthe-counter tests is risky. Demand for testing has plunged dramatically since the height of the winter surge and may not rebound as more people are vaccinated.
“You clearly are at risk of missing the market,” said Michael Greeley, cofounder and general partner at Flare Capital Partners, a venture capital firm focused on health care technology.
But Douglas Bryant, president and CEO of Quidel Corp., remains unfazed, even after the diagnostics manufacturer’s testing demand dropped by about one-third in the past two months.
“The level of testing for people with symptoms and the ‘worried well,’ who see others getting tested and think they should, too, is subsiding,” Bryant said. “But once we start to get more people vaccinated, the government will move from campaigning to get people vaccinated to saying, ‘Please test yourself regularly so we can get back to work.’”
Quidel, headquartered in San Diego, recently unveiled its latest test, the QuickVue At-Home COVID-19 Test, which takes 10 minutes to detect the coronavirus by homing in on specific proteins, called antigens. The FDA authorized the test for over-the-counter use Wednesday, and Quidel plans to announce retail partners in the coming weeks.
The FDA said in midMarch it would speed the pipeline for “screening testing,” including at-home covid tests that don’t require consumers to have symptoms or a prescription.
In February, the Biden administration cut a $232 million deal with Ellume, whose rapid antigen test was authorized by the FDA in December. Paired with an app, the test takes 15 minutes to analyze after a nose swab.
The Australian company currently ships hundreds of thousands of test kits a week to the U.S. from its factory in Brisbane to large companies and the Department of Defense. It plans to be on the shelves of multiple pharmacies by the second half of the year and in one major retailer in April, said Dr. Sean Parsons, the company’s founder and CEO.
“We are going as fast as we can possibly go,” he said.