USA TODAY US Edition
RAPID, CHEAP HOME TESTS: COMPANIES ATTEMPT TO MAKE COVID-19 TESTS WIDELY AVAILABLE
Nearly two months after federal regulators unveiled rules for at-home coronavirus tests, no company has federal approval to sell these fast and cheap tests even though the technology is ready.
Molecular PCR tests processed at medical labs remain the standard of accurate testing, but they are more expensive and results can take days to process.
Antigen tests are less expensive, plentiful and deliver results in minutes. Three companies gained Food and Drug Administration authorization to sell antigen testing machines to labs or clinics. A fourth company, Abbott Laboratories, won approval to market a $5 rapid, credit card-sized test administered by a health care professional.
But no company has been cleared to sell tests directly to consumers for widespread screening – a step some believe is necessary to slow the spread of COVID-19.
“The way to get this under control is if people find out as early as possible they are infected and then quarantine from others,” said Dr. Yukari Manabe, a Johns Hopkins University professor of medicine.
The United States needs 30 million tests a week to adequately track the virus, according to the Rockefeller Foundation. Labs have worked round the clock and reached 1 million daily tests for the first time last week. That’s about one-quarter of Rockefeller’s goal of more than 4 million tests each day, according to the COVID Tracking Project.
Testing in many states is limited to people exposed to the virus or sick. Routine screening could prevent the spread among people who have the virus but don’t have any symptoms. If people test themselves before going to work, restaurants or school, it could significantly reduce transmission.
Rapid test studies underway
Illinois-based Abbott in August became the first company to gain approval of a rapid antigen test using “lateral flow” technology, similar to a pregnancy test. The U.S. Department of Health and Human Services will spend $750 million to purchase 150 million tests with the first shipments expected this month.
Gaining FDA authorization for these inexpensive, at-home tests is no easy task. The agency’s template says at-home tests should correctly identify positive cases at least 90% of the time. This sensitivity threshold is higher than antigen tests the agency has authorized for point-of-care or lab settings.
The agency also wants companies to conduct studies on how tests work on patients. The FDA recommends studies with at least 150 people, of which at least 30 people test positive for the virus.
Cambridge, Massachusetts-based, E25Bio is studying its antigen test on people without symptoms at a co-working space in the Boston area. The company already has applied to market its rapid antigen test as a diagnostic that can be used at labs. The company wants to gather enough data to apply for at-home testing, said Carlos-Henri Ferré, E25Bio’s director of operations and communications.
Ferré said the FDA's template for at-home testing requires a sensitivity level higher than other forms of antigen testing. “If we’re talking about a screening device, the parameters don’t need to be the same as an ultimate diagnostic test,” he said. “We hope the (FDA’s) language would change and reflect what we’re creating, which is a screening tool for public health.”
“If we’re talking about a screening device, the parameters don’t need to be the same as an ultimate diagnostic test. We hope the (FDA’s) language would change and reflect what we’re creating, which is a screening tool for public health.” Carlos-Henri Ferré, E25Bio’s director of operations and communications