Wednesday, March 25, 2020

3D-printing company Formlabs expects its swabs to receive FDA exemption

Unknown March 25, 2020 TechCrunch

Formlabs, the privately held, Massachusetts-based 3D-printing company, will soon receive an exemption from the U.S. Food and Drug Administration for its swab designed for use in COVID-19 test kits, TechCrunch has learned.

Global supply chains for test kit components including swabs and chemical reagents have hampered the ability of governments to increase testing to a point where they can adequately ascertain the scope of the outbreak of the novel coronavirus within their borders.

“Yesterday we got a notification from the FDA that this is going to be a class one exempt product,” said Formlabs chief product officer David Lakatos. “As long as it’s manufactured in an ISO 135 controlled facility.”

As cases are identified across the U.S., tests are flowing to the geographies where the disease has spread the fastest, leaving other parts of the country under-resourced to address what could be an increasing outbreak in other communities that have yet to receive a complete picture of the disease’s spread.

With swabs, the problem has been compounded that of the few manufacturers of the sorely needed test kit component, only one is in the U.S. while another is in Italy.

“About a week and a half ago we joined this effort,” says Lakatos.

Formlabs is uniquely positioned to scale up production he said, thanks in part to the 60,000 printers the company has on hand and the recent acquisition of a facility in Ohio that enables the company to make surgical-grade products.

The company is currently finishing up human trials and gearing up to expand capacity at its Ohio manufacturing facility. According to Lakatos, the company will be able to supply 100,000 swabs per day. “We are starting to print these,” Lakatos said. “But we won’t send anything out until we get the green light.”

Currently most of the swabs are earmarked for partner hospitals that worked with the company to develop the swabs, but the company is also working with large distributors to access their distribution channels and get the swabs into roughly 3,000 hospitals around the U.S.

“At the end of the day we’re just looking to get them out,” Lakatos said.