Quest Diagnostics, LabCorp, Mayo Clinic roll out COVID-19 tests in US
The Mayo Clinic has begun rolling out a test to detect the virus that causes COVID-19 illnesses, a development that comes as concerns build over testing capacity that could thwart a robust response to the outbreak.
Mayo’s large commercial lab in Rochester is one of several that have scrambled in recent weeks to create a test that can detect coronavirus in specimens. The lab says it started making tests available to health care providers at Mayo on Thursday and will open the supply to others in the coming days. Mayo’s initial capacity of 200 to 300 tests per day is expected to grow in the coming weeks.
Creating a new test usually takes months or even a year, clinic officials say, but they opted to fast-track development of the new test beginning in mid-February after watching the virus overwhelm the health care system in China, where the outbreak strain of coronavirus originated.
“Trying to develop a test in a span of weeks is difficult,” said Matthew Binnicker, director of the clinical virology lab at Mayo Clinic in Rochester. “We’ve been working diligently, around-the-clock.”
Mayo Clinic Laboratories is a large commercial lab in Rochester that receives every day thousands of samples from clinics and hospitals around the world, not just from health care providers at Mayo’s primary medical centers in Minnesota, Arizona and Florida. Last year, the lab completed about 25 million tests.
While Mayo is one of the largest hospital-affiliated reference labs, the much larger lab testing giants Quest Diagnostics and LabCorp also have launched their coronavirus tests over the past week or so. A diagnostic also was developed by a company in Iowa called Integrated DNA Technologies, and the Cleveland Clinic said Thursday it will soon have capabilities for on-site testing.
While President Donald Trump said late last week that anyone who needs a coronavirus test is getting one, others have raised doubts about the nation’s supply and cited the much larger number of tests being performed in South Korea.
Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration (FDA) in the Trump administration, said via Twitter on Thursday that the U.S. likely lost its chance for following South Korea’s path in controlling the spread, but must focus on averting the tragedy that’s hitting Italy. One of the keys, Gottlieb wrote, is for commercial labs to dramatically expand the supply of coronavirus tests.
For weeks, Gottlieb has questioned the government’s initial strategy to concentrate coronavirus testing at the Centers for Disease Control and Prevention (CDC) without also developing alternative sources. He wrote on Twitter in early February: “Since CDC and FDA haven’t authorized public health or hospitals to run the tests, right now CDC is the only place that can. So, screening has to be rationed.”
Initially, the FDA granted what’s called an emergency use authorization only for the CDC’s test for coronavirus, Mayo Clinic officials say. The decision meant that any other test developed by a lab or manufacturer would be required to go through an approval process, Mayo says, before it could be used for routine testing.
The federal government issued a new policy in mid-February as the demand for testing increased, and stretched testing capacity at CDC and state health labs. The new policy allowed certain clinical labs certified by the federal government to develop and validate their own tests, clinic officials said, and begin using them before FDA finished reviewing data.