Fluxergy Earns CE Mark for COVID-19 Test

Fluxergy has received CE mark certification for its reverse transcription polymerase chain reaction (RT-PCR) COVID-19 test.

The coronavirus test is conducted at point-of-care settings using the Fluxergy Analyzer, which returns test results identifying the presence of the SARS-CoV-2 virus in under one hour. It does not require RNA extraction.

To use the on-site test, a small nasal swab sample is mixed with a reagent solution, loaded into an accompanying card and placed in the company’s analyzer.

The Irvine, Calif.-based company has also submitted the test for FDA Emergency Use Authorization.