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Coping with COVID: Lee’s Summit diagnostics company receives FDA approval for COVID-19 test kit

Kansas City metro-based Viracor Eurofins has received authorization for its development of an at-home COVID-19 test kit from the Food and Drug Administration, the kit testing for the presence of the virus and not antibodies.

Viracor Eurofins in Lee’s Summit has now received approval from the the Food and Drug Administration (FDA) for its development of an at-home Covid-19 test kit.

The FDA gave emergency-use authorization for the test kit, a swab resembling a Q-tip that Viracor Eurofins says in less invasive than others on the market.

Users need only to stick the swab a couple of centimeters to an inch inside their nose, she said. The kit builds on an earlier test Viracor released in March and looks for the presence of the virus, not antibodies. It also looks for a second marker to ensure that the sample was collected properly. 

The Lee’s Summit clinical specialty lab developed the at-home test over a four-week period earlier this summer, but it took awhile to receive authorization from the FDA, which has been inundated with requests. 

The at-home test kits are available online through empowerDX, a direct-to-consumer company owned by Viracor’s parent company, Eurofins Scientific. Each kit is $89 and includes the cost of to-and-from shipping via FedEx.

Viracor performs the testing and emails the results in 24 to 48 hours after receiving the sample. Viracor already is contemplating avenues to expand the test’s availability and is considering adding a business-to-business option, which fits its Safer@Work Program. 

The company also released a Covid-19 saliva test on Monday for health care providers to administer, and it hopes to release an at-home version in the next few months. In about a month, the company aims to make available a combined test for coronavirus, influenza A and B, and respiratory syncytial virus. Symptoms can overlap, Altrich said. 

“It’s really part of our mission to be a part of the solution and the continuing fight of this pandemic because we know that it really is going to be a collective response that is going to give us success against the virus,” she said. “We’re proud to be playing a leading role.”