Coronavirus test manufacturer Quest Diagnostics announced Wednesday that the Food and Drug Administration has granted the company emergency authorization to use a new technique it says will cut the testing turnaround time to two to three days for most people.
Commercial testing laboratories such as Quest and rival LabCorp have struggled to keep pace with testing as Covid-19 outbreaks spread across the American South and West. Public health specialists have stressed that the current testing delays render the tests essentially worthless because it takes so long to get results that by the time people find out they have the virus, they may have already passed it along to others.
On Monday, Quest said the average turnaround time for Covid-19 test results had slowed to more than two days for top priority patients, which include hospital patients, some pre-operative patients and symptomatic health-care workers. The company added that for all others, testing turnaround time was more than seven days.
But with the new FDA authorization, the company said it expects "to achieve average turnaround times of 1 day for 'Priority 1' patients and 2-3 days for all other patients in coming weeks." The new technique, which "speeds the process of extracting viral RNA from specimens," will also boost Quest's overall testing capacity, the company said.
The company now expects to be able to perform 150,000 tests per day by next week and 185,000 per day by Labor Day.
The lag and limited testing capacity applies only to molecular, or PCR tests, which are the most reliable on the market, but they are also the most exposed to weaknesses in the supply chain. Adm. Brett Giroir, assistant secretary at the Department of Health and Human Services, and other members of the White House coronavirus task force have repeatedly defended U.S. testing, pointing to other rapid tests available on the market. However, those tests tend to misdiagnose patients more often than molecular tests.
"Laboratory innovation is key to optimizing testing capacity for COVID-19," Steve Rusckowski, CEO of Quest, said in a statement. "We appreciate the collaboration of the FDA to bring this technique to several of our labs spanning the U.S. With more testing capacity, we expect to improve turnaround times for our customers and patients."
If Quest is able to bring its turnaround time for non-prioritized patients down to two to three days, that would put it close to rival LabCorp, whose CEO said on a conference call earlier this week that its turnaround time is already two to three days for all patients and faster for priority patients.
LabCorp CEO Adam Schechter also stressed the need for continued innovation in the space, especially headed into the fall as flu season settles in.
"Covid-19 with the flu season is going to be more problematic than where we're at today," he said Tuesday, adding that it will be difficult for employers, hospitals and universities to try to distinguish between flu and Covid-19 patients. Diagnostic tests, he said, might become even more important, especially reliable molecular tests.
He added that new testing technology is constantly being considered that could alleviate the demand of the molecular tests provided by Quest and LabCorp. But he said much of that technology currently supplements the company's molecular tests. It doesn't replace them.
"We want to build as much capacity as fast as we can for whatever comes out of the flu season," he said on the call. "We're doing really well in terms of our turnaround, but we've got to keep building because we don't know what the bind is going to be in the fall and we won't rest until we build and build and build as much as we can."