FDA Rejects Lumos Diagnostics’ 510(k) Application for FebriDx

Lumos Diagnostics announced that the FDA has rejected the company’s 501(k) application for its FebriDx test for use in differentiating bacterial from viral infections.

FebriDx is a CE-marked point-of-care test that delivers results in 10 minutes, using a fingerstick blood sample to identify a host response to either a bacterial or viral infection.

The FDA cited concerns about the risk of false negative results leading to delays in treating infected COVID-19 patients, which could exacerbate the pandemic. Lumos said it will appeal the FDA’s decision — which could result in a positive decision within 90 days — or it may resubmit a 510(k) application.

“I will be actively working with our regulatory team and advisors to review this feedback and to develop a revised commercial plan,” said Lumos CEO Doug Ward.