theinformationsuperhighway said Formlabs, the privately held Massachusetts-based 3D printing company, will soon receive an exception from the U.S. Food and Drug Administration for its swab designed for use in COVID-19 test kits.
Global supply chains for test kit components, including swabs and chemical reagents, have hampered governments' ability to increase testing to the extent that they can adequately determine the extent of the outbreak of the novel coronavirus within its limits.
"We received a notification from the FDA yesterday that this would be a Class 1 product," Formlabs said Chief Product Officer David Lakatos. "As long as it is manufactured in an ISO 135 controlled facility."
While cases are identified in the U.S., tests flow to the regions where the disease has spread the fastest and leave other parts of the country underserved to address the potentially increasing outbreak in other communities that have not yet received a complete picture of the Spread of the disease.
With swabs, the problem has worsened that of the few manufacturers of the urgently needed test kit component, only one is in the USA and another in Italy.
"We joined this effort about a week and a half ago," says Lakatos.
Formlabs is in a unique position to increase production, thanks in part to the company's 60,000 printers available and the recent acquisition of an Ohio plant that enables the company to produce surgical quality products.
The company is currently completing human trials and is preparing to expand capacity at its Ohio manufacturing facility. Lakatos says the company will be able to deliver 100,000 swabs a day. "We're starting to print them," said Lakatos. "But we won't send anything out until we get the green light."
Most swabs are currently intended for partner hospitals that have worked with the company to develop the swabs. However, the company also works with major retailers to gain access to their sales channels and to bring the swabs to around 3,000 hospitals in the United States.
"Ultimately, we just want to get them out," said Lakatos.