Fluxergy, Irvine, Calif, has submitted a request for an FDA emergency use authorization that would permit medical professionals to begin using the company’s high-speed research use only test system as a covid-19 diagnostic at the point-of-care.
The Fluxergy analyzer system utilizes polymerase chain reaction amplification and microfluidics technology. In bench lab tests performed by the company, and in follow-up validation tests with patient samples completed by researchers at the University of California, San Diego, the analyzer has been shown to accurately identify the SARS-CoV-2 virus in less than 1 hour.
Fluxergy’s onsite sample-to-answer test for covid-19 requires a very small sample, typically a nasal swab. The swab is mixed with a reagent solution, loaded onto the Fluxergy card, and inserted into the Fluxergy analyzer in a convenient two-step procedure.
“The worldwide shortage and inaccessibility of covid-19 tests have been major impediments to containing the pandemic in the United States and globally,” says Ali Tinazli, PhD, chief commercial officer at Fluxergy. “We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology.”
For more information, visit Fluxergy.