FDA Clears bioMérieux’s 15-Disease Point of Care Respiratory Test

The FDA has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for bioMérieux’s point-of-care Biofire Spotfire system and accompanying R Panel which detects 15 common bacteria, viruses and viral subtypes, including COVID-19.

The system, which delivers results in about 15 minutes during a patient visit, is designed to be used by non-laboratory personnel and can be expanded to include up to four testing modules.

The test was reviewed through the dual 510(k) and CLIA Waiver pathway, and is the first COVID-19 test to be cleared with a CLIA waiver, the company said. CLIA waivers are issued for tests considered so simple to perform that there is little risk of error.

The company plans to market the device in April and to add more panels to test for other diseases.