Quest Says FDA Approves New ‘Laboratory Method’ That Will Reduce Delays In Coronavirus Testing


A Quest Diagnostics Inc. application form is displayed for a photograph at Perry Memorial Hospital in Princeton, Illinois, USA, on Wednesday October 11, 2017.

Daniel Acker | Bloomberg | fake pictures

Coronavirus testing maker Quest Diagnostics announced Wednesday that the Food and Drug Administration has granted the company emergency authorization to use a new technique that it says will reduce the test’s response time to two to three days for most people.

Commercial testing labs like Quest and rival LabCorp have struggled to keep up with testing as Covid-19 outbreaks spread across the southern and western United States. Public health specialists have emphasized that delays in current testing make testing essentially useless because it takes so long to get results that by the time people discover they have the virus, they may have already passed it on to others.

On Monday, Quest said the average response time for Covid-19 test results had been reduced to more than two days for top-priority patients, which include hospital patients, some preoperative patients, and symptomatic healthcare workers. The company added that for everyone else, the test response time was more than seven days.

But with the new FDA clearance, the company said it hopes to “achieve average response times of 1 day for ‘Priority 1’ patients and 2-3 days for all other patients in the coming weeks.” The new technique, which “speeds up the process of extracting viral RNA from samples,” will also increase Quest’s overall testing capacity, the company said.

The company now expects to be able to run 150,000 tests per day next week and 185,000 per day on Labor Day.

Delay and limited testability apply only to molecular or PCR tests, which are the most reliable on the market, but are also the most exposed to weaknesses in the supply chain. Admiral Brett Giroir, deputy secretary of the Department of Health and Human Services, and other members of the White House coronavirus task force have repeatedly defended tests from the United States, pointing to other rapid tests available on the market. However, these tests tend to misdiagnose patients more often than molecular tests.

“Innovation in the lab is key to optimizing the test capacity for COVID-19,” Steve Rusckowski, CEO of Quest, said in a statement. “We appreciate the collaboration of the FDA in bringing this technique to several of our laboratories spanning the United States. With more testing capacity, we hope to improve response times for our clients and patients.”

If Quest can reduce its response time for non-prioritized patients to two or three days, that would bring it closer to rival LabCorp, whose CEO said in a conference call earlier this week that his response time is already two to three days. . for all patients and faster for priority patients.

LabCorp CEO Adam Schechter also stressed the need for continuous innovation in the space, especially before fall as the flu season sets in.

“Covid-19 with the flu season is going to be more troublesome than where we are today,” he said Tuesday, adding that it will be difficult for employers, hospitals and universities to try to distinguish between flu patients and patients with Covid-19. . Diagnostic tests, he said, could become even more important, especially reliable molecular tests.

He added that a new testing technology is constantly being considered that could alleviate the demand for molecular testing provided by Quest and LabCorp. But he said much of that technology currently complements the company’s molecular testing. It does not replace them.

“We want to develop as much capacity as quickly as we can for what comes out of the flu season,” he said in the call. “We are doing very well in terms of our change, but we have to keep building because we don’t know what the problem will be in the fall and we won’t rest until we build and build and build as much as we can.”

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