Idexx-made COVID-19 test kits get emergency approval from FDA

The U.S. Food and Drug Administration has issued emergency authorization for the use of human COVID-19 test kits produced by a subsidiary of Westbrook-based Idexx Laboratories Inc.

The effectiveness of the test kits was previously validated by the Institut Pasteur of France, the company said in a news release Thursday. The test kits are being produced by Idexx subsidiary Opti Medical Systems of Roswell, Georgia.

The test kits provide results in roughly two to three-and-a-half hours, Idexx said.

“This advancement is a true reflection of our talented global team coming together and leveraging innovation across our organization to bring a diagnostic solution to support COVID-19 testing during this unprecedented pandemic,” Jay Mazelsky, president and CEO of Idexx, said in the release.

Opti Medical Systems specializes in the design and manufacturing of point-of-care and laboratory diagnostics for human medicine, the company said. It uses advanced diagnostic technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use and clinical flexibility.

“The Opti … test has an easy workflow with simple pipetting steps, making high throughput testing easy for medical technologists to perform,” Dr. Hayley Webber, technical director of molecular diagnostics at NorDx Laboratories of Scarborough, said in the release. “This minimizes errors and allows for effortless scalability.”

Gov. Janet Mills announced Thursday that the state of Maine is partnering with Idexx to purchase up to 5,000 COVID-19 test kits per week, tripling testing capacity statewide.

The move will expand the availability of tests for anyone in Maine suspected of having the coronavirus and eliminate the need to limit testing to only the most critical outbreaks and cases.