1 Hour Coronavirus Test Awaiting FDA Approval

IRVINE, CA — Orange County-based medical diagnostic company Fluxergy, along with UC San Diego researchers, have taken the next step toward getting a high-speed test for new coronavirus available for use, the company announced Monday. If approved, the device would be able to identify results for coronavirus in about an hour, they say.

On Monday, Fluxergy submitted an emergency use authorization request to the U.S. Food and Drug Administration Center For Devices and Radiological Health. That authorization would permit medical professionals to begin using the Irvine company's test system as a coronavirus or COVID-19 diagnostic at the point-of-care.

The hardware and cloud-based system, which works off Fluxergy Cards—what they describe as a "lab-on-chip" is cost-effective and scale-able, the company says. The Fluxergy Analyzer system has produced results that identify the SARS-CoV-2 virus in under one hour after patient samples completed one week ago.

As many as 256 Fluxergy Analyzers can be managed on a local server, they say. The cloud-based software will provide "powerful access to help manage patient data," a spokesperson for Fluxergy said. The Fluxergy Analyzer is about the size of a small desktop computer. The system does not require the virus RNA to be purified before the test can be performed.

This is not the only analysis system out there. Last week, Abbott Labs won emergency FDA approval for their testing system. Last week, California-based Roche Molecular Solutions received emergency FDA approval to begin distributing its new COVID-19 testing.

Getting reliable results in a short span of time is essential in dealing with the global pandemic, experts say.

The UCSD physician-scientist research team that conducted the validation, completed Friday, was led by Dr. Davey Smith, a professor of medicine and head of the UCSD Division of Infectious Diseases and Global Public Health. Smith is a member of the Fluxergy Medical Advisory Board.

"The best thing it could do is triage patients pretty quickly," Smith said. "In someplace like a nursing home or hospital, if you see someone who may be transmitting the disease, do you have to quarantine all those people he interacted with? Maybe, but you can test that person and quickly know."

Smith said UCSD could currently get test results back in around eight hours. San Diego County was taking a day or longer to get results, and other labs sending to central labs could range from three days to two weeks.

Advanced rapid point-of-care tests for COVID-19 may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy's on-site sample- to-answer test for COVID-19 requires a tiny sample, typically a nasal swab, which is mixed with a reagent solution, loaded onto a card and inserted into the analyzer in a two-step procedure.

"The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the U.S. and globally," said Dr. Ali Tinazli, 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."

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