Fluxergy's on-site sample-to-answer test needs a small sample for the detection of COVID-19 disease
Research and medical diagnostic test company Fluxergy is seeking emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) For Devices and Radiological Health for its on-hour COVID-19 test system.
The company has submitted the application to the FDA for EUA status for the high-speed research use only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC).
The Fluxergy Analyzer system applies advanced PCR and microfluidics technology
The Fluxergy Analyzer system, which applies advanced PCR and microfluidics technology, is expected to save significant time compared against standard lab tests that need to be shipped to centralised laboratories for processing.
According to the company, the Fluxergy Analyzer system was demonstrated to precisely detect the SARS-CoV-2 virus within one hour in bench lab tests conducted by the firm and in follow-up validation tests with patient samples completed this week by researchers at University of California San Diego (UC San Diego).
The on-site sample-to-answer test for COVID-19 needs a small sample, generally a nasal swab.
The swab will be blended with a reagent solution, loaded onto the Fluxergy card and infused into the Fluxergy Analyzer in a convenient two-step procedure.
Fluxergy chief commercial officer Dr Ali Tinazli said: “The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the U.S. and globally.
“We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology.”
Fluxergy’s solution is a portable testing platform, which is based on three core elements such as the single-use consumable Fluxergy Card, the Fluxergy Analyzer, and its user interface Fluxergy Works.
Separately, South Florida-based disaster recovery firm Disaster Management Group (DMG) has introduced a 15-minute COVID-19 screening tool, which helps in limiting the spread of coronavirus.