Fluxergy nabs CE-IVD mark for SARS-CoV-2 POC PCR test

Diagnostic startup Fluxergy announced that its COVID-19 RT-PCR test has received CE-IVD marking.

The Irvine, California-based company’s automated, sample-to-answer Fluxergy Diagnostic Testing System has the ability to run multiple different assay types at the same time, such as molecular, immunochemistry, cytometry, and chemistry tests, on the same cartridge. The Fluxergy COVID-19 Sample-to-Answer-RT-PCR test returns results in one hour.

The firm is now seeking commercial partnerships with healthcare providers and “potential international go-to-market partners in Europe, Asia, and Australia,” CCO Ali Tinazli said in a statement. The company has expanded manufacturing capabilities for the testing system to 1 million tests per month, it said in a statement.

Fluxergy had previously made its platform available for research use only with its partners, including University of California, San Diego and Mass General Brigham.