A clinical diagnostics lab in Lee’s Summit has developed a test for the novel coronavirus and says it's more than 99% accurate.
Viracor Eurofins, which was founded in 1983, says it's capable of performing more than 1,000 tests per day and returning results the same day. The test will allow clinicians to expand testing to patients who currently don't meet the eligibility criteria for public laboratory testing established by the Centers for Disease Control and Prevention.
“This is a molecular test that detects part of the virus’ genome,” said Steve Kleiboecker, the company’s vice president of research and development.
The test is done with chemicals and reagents – compounds used to detect other substances – which allows it to be performed in a short period of time.
“There is no waiting for the virus to grow in a culture or something like that,” Kleiboecker said. “It’s a very rapid process.”
Although Viracor's test has yet to be approved by the Food and Drug Administration, the company is certified by the Centers for Medicare and Medicaid Services to submit human samples for diagnostic testing. With that certification, the lab can proceed to perform the tests and then send the data to the FDA for review.
“And we wouldn’t do that, of course, unless we were extremely confident that we had dotted all the i’s and crossed all the t’s to the FDA’s satisfaction,” Kleiboecker said. “So we’ve completed our internal validation, and over the next 15 business days we will send the FDA a packet with all that data included, and they will provide a final approval.”
The Missouri Department of Health and Senior Services, the state health agency, has given Viracor the green light to begin testing. And the Kansas Department of Health and Environment says it welcomes the additional capabilities Viracor provides.
“We are very excited for private companies to come on board to test for Covid-19,” says Kristi Zears, a spokeswoman for the agency. “The more testing facilities we can have working to identify this, the better.”
At least one major area hospital network, Saint Luke’s Health System, confirmed that it is using Viracor.
“I can tell you we’re working with them to increase our testing capability,” said Laurel Gifford, a spokeswoman for Saint Luke’s.
Leslie Carto, a spokeswoman for Truman Medical Centers, said the safety-net hospital also is working with Viracor.
“We have a contract with them, and they are doing testing for COVID-19 that the state lab is not,” Carto said. “We are sending over samples that the state wouldn't test based on CDC guidelines but that our physicians want answers to.”
Bob Hallinan, a spokesman for the area’s largest hospital network, the University of Kansas Health System, said KU is not using Viracor but is shipping samples to the state health department for testing.
“We’re looking for a way down the road to find a way to do our own testing as well as collecting the samples,” he said.
Viracor claims to have about 200 medical provider clients that it works with on a regular basis, and about 80 of those have shown interest in the tests, according to Kleiboecker. That number is likely to increase since Viracor works with another 200 hospital systems across the country.
The company has about 300 employees, but it says it can rapidly ramp up that number if demand for its test requires it. Viracor is promising test results within 12 to 18 hours after a sample comes through the door.
“And if that means we have to work late at night and keep additional shifts, everybody’s up for that challenge,” Kleiboecker said.
The CDC is urging clinicians to work with local and state health departments to coordinate testing through public health laboratories. But it also says that clinicians can access laboratory tests for diagnosing COVID-19, the disease caused by the novel coronavirus, through clinical laboratories performing tests authorized by the FDA under an Emergency Use Authorization (EUA).
In 2016, Viracor received just such authorization for its Zika virus test. So far, just a handful of private labs have received FDA approval for their COVID-19 diagnostic tests, but Viracor says it expects to be among them once it submits its data to the FDA.
The U.S. has been struggling with an inadequate supply of tests – as of last week, only about 19,000 have been performed nationwide, or about 23 tests per million people (compared with South Korea, which has run 250,000 tests, or about 3,692 per million people). That means infected people have gone undiagnosed, allowing for community spread of COVID-19.
Missouri had tested 170 individuals as of Monday, according to the Department of Health and Senior Services; six of them tested positive. Kansas had tested 245, according to KDHE spokeswoman Zears, and nine tests had come back positive.
Kleiboecker said Viracor started working on its test shortly after the first reports of the illness began to emerge from China late last year.
“And about six weeks ago, we said, ‘OK, this is very important. This is very real, and we think we can make a good contributions to the care of patients.’ And so that’s when we put a team on it, and they've worked tirelessly over the last six weeks to get where we are today.”
Viracor is a subsidiary of Eurofins Scientific, which boasts 800 laboratories in 47 countries. The company’s shares are listed on the Euronext Paris Stock Exchange.
This story was updated with additional information about Kansas tests.
Dan Margolies is a senior reporter and editor at KCUR. You can reach him on Twitter: @DanMargolies