Physician-scientists at the University of California, San Diego (UCSD) are the first to evaluate a new diagnostic testing system designed by Irvine, California-based Fluxergy, that holds promise for identifying the SARS-CoV-2 virus (COVID-19) in 45 minutes to one hour.
Initial tests by Fluxergy researchers using a synthetic SARS-CoV-2 virus suggest this system has the potential to change the landscape for point of care (PoC) diagnostic testing for COVID-19, dramatically reducing the time it takes to get results, and delivering those results directly at the patient bedside. Such a test, if validated by physician-scientists at UCSD, would potentially eliminate the need to send patient samples to centralized labs, significantly speeding up the time it takes to get results.
"Health providers have struggled to contain the rapid spread of COVID-19 in the U.S. and throughout the world in part because of a significant shortage of available lab tests that can quickly, efficiently and cost-effectively confirm whether patients have been infected with the virus," says Fluxergy Co-Founder and President Tej Patel. "In bench lab testing at our research facility, utilizing a synthetic virus based on the RNA sequence made available to medical organizations, we have been able to consistently and accurately confirm in under one hour the presence or absence of SARS-CoV-2."
Last week, the UCSD research team began an initial benchtop evaluation of the Fluxergy system using the SARS-CoV-2 virus from patients in San Diego. This evaluation is expected to be completed within one week, according to Dr. Davey Smith, Professor of Medicine and Head of the UCSD Division of Infectious Diseases and Global Public Health, who is leading the UCSD evaluation team. Dr. Smith is a member of the Fluxergy Medical Advisory Board. If the benchtop performance of the Fluxergy testing system is validated, the UCSD team plans to use the Fluxergy system to test for COVID-19 at the patient bedside at the UCSD Medical Center in accordance with FDA's guidance while it pursues an Emergency Use Authorization (EUA).
One of the advantages of the Fluxergy system is that it is lightweight and portable – the Fluxergy Analyzer is about the size of a small desktop personal computer – which makes it applicable in a variety of clinical settings. Importantly, the Fluxergy system also does not require the SARS-Cov-2 RNA to be purified before the test can be performed. Samples are placed directly on a disposable sample-to-answer Fluxergy test card, which uses printed circuit board technology and microfluidics to automate various sample processing steps.
Fluxergy is hopeful that the evaluation by UCSD physician-scientists may result in quicker identification of the presence of the SARS-CoV-2 virus. This could potentially reduce delays that have been seen in getting back results from tests that are processed in centralized labs away from the Point of Care. If so, Fluxergy technology might thereby help mitigate the further spread of COVID-19.
The Fluxergy system is currently available as a Research Use Only (RUO), or Investigational Use Only (IUO) 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 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.