ElitechGroup MDx submitted a coronavirus test manufactured at its facility in Bothell to the Food and Drug Administration for emergency use authorization, the company announced this week.
ElitechGroup’s product is a four-in-one diagnostic test that detects and differentiates the coronavirus from other common flus, such as influenza A and B and respiratory syncytial virus.
The test requires a sample from the nose or throat. It is designed for diagnostic laboratories that collect samples from health care providers, said Bruce Bond, director of marketing for ElitechGroup.
It takes around two and a half hours to get results after the sample is loaded into the testing system, said Marcello Salio, chief operating officer and general manager for the company.
ElitechGroup is a biotechnology and diagnostic equipment group based in France. In 2009, it acquired Bothell-based Epoch Biosciences, now ElitechGroup Molecular Diagnostics.
In April, ElitechGroup worked with Korea-based Osang Healthcare to distribute a rapid coronavirus detection kit. With flu season approaching, Salio said the company decided three months ago to develop its own fast-acting test that could detect illnesses that are “easily confused” with Covid-19.
Many countries have seen a spike in Covid-19 cases in the past few weeks. On Wednesday, the United States saw more than 172,000 new cases in a single day. Washington state saw more than 1,500 on the same day.
“(Respiratory syncytial virus) is an infection that usually hits children,” said Bruce Bond, director of marketing for ElitechGroup. “As they’re anticipating a lot of confusion this fall with people coming in sick … doctors and health officials need to rapidly find out who has Covid and who has the flu.”
Obtaining emergency use authorization from the FDA is a process that providers of coronavirus tests must go through before distribution. If ElitechGroup gets the authorization, it has the capacity to manufacture and distribute 500,000 tests a month, said Salio.
“This fall, the United States has seen an alarming surge of Covid-19 cases, and now more than ever, it’s critical we focus on making reliable testing accessible for all health systems,” Christoph Gauer, CEO of Elitech Group, said in a press release.
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