NewsTeam 10 Investigates


Researchers evaluating one-hour test

Posted at 7:08 PM, Mar 17, 2020
and last updated 2020-03-17 22:08:52-04

SAN DIEGO (KGTV) - An Orange County-based company believes it could change the current healthcare landscape with one-hour COVID-19 testing.

According to officials at Fluxergy, initial tests by researchers using a synthetic SARS-CoV-2 virus suggest this system has the potential to change the landscape for point-of-care diagnostic testing for COVID-19. It would dramatically reduce the time it takes to get results and deliver those results directly at the patient’s bedside.

The company said it could be able to identify the virus in as little as 45 minutes.

"The typical laboratory tests that you do in a central lab or the doctor's office, you collect the sample and get that sent out to a central lab," said Fluxergy President Tej Patel. "We do those same types of tests, but in a single device, I want to say that's the size of a small PC or a shoebox-size device."

Last week, the research team at UC San Diego began an initial benchtop evaluation of the Fluxergy system using the SARS-CoV-2 virus from patients in San Diego the company said.

Patel told 10News Fluxergy technology aims to take that same test, put it in a single device, and make it portable. He said the changes to the system will make for easier access by removing some medical barriers.

"Our goal is to kind of democratize testing and increase the accessibility to testing," Patel said. "So when you try to focus your system more on point-of-care testing, where you make testing much easier to gain access to, where you don't have to go through your doctor or other provider, and not have to worry about reimbursement. If you can just go and do these tests, it's going to really elevate in general the whole healthcare system."

"We need to test and test," said UC San Diego’s Dr. Davey Smith. "The countries that have done best to lower their mortality have done best by flattening the curve by testing where the infections are happening and knowing who's getting infected."

Dr. Davey Smith is the head of the UCSD Division of Infectious Diseases and Global Public Health.

Smith said immediate testing would give doctors an advantage.

"It's only going to be in certain situations, really point-of-care contact, and it will be for special circumstances that we’ll be able to make clinical decisions on right away," Smith said.

According to Fluxergy, "The Fluxergy system is currently available as a Research Use Only, or Investigational Use Only device for the development of new diagnostic products. The Fluxergy system has not yet been reviewed or approved by the FDA. However, as noted, if the physician-scientists at UCSD obtain promising validation results using the system, they intend to begin immediate use of the diagnostic consistent with FDA's guidance and pursue an Emergency Use Authorization (EUA). An EUA would then enable the UCSD CLIA-certified diagnostic laboratory to continue to utilize the Fluxergy system with patients who need to be tested for the SARS-CoV-2 virus, subject to the terms and conditions set forth by FDA in the authorization."