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New Point of Care COVID-19 Test May Deliver Results Within 60 Min.

New coronavirus test may be able to confirm COVID-19 in under one hour at the point of care (patient's bedside)

by Fluxergy LLC
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IRVINE, CA — PRNewswire — Physician-scientists at the University of California, San Diego (UCSD) are the first to evaluate a new diagnostic testing system designed by Irvine, CA-based Fluxergy, that holds promise for identifying the SARS-CoV-2 virus (also known as the novel coronavirus) in as little as 45 minutes and typically within one hour.

The Fluxergy diagnostic testing system.
Fluxergy LLC

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.

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"Health providers have struggled to contain the rapid spread of COVID-19 in the US 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," said 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.

"Our vision is to make it possible for clinicians to quickly perform sophisticated diagnostic tests and quickly get back results right at the patient's bedside or in accessible urgent care settings where this information is needed the most," said Patel.

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.

COVID-19 is the infectious disease caused by the novel coronavirus SARS CoV-2, which was first discovered in Wuhan, China in December 2019 and now has been declared by the World Health Organization to be a pandemic. In humans, coronaviruses are known to cause respiratory infections ranging from moderate to severe symptoms; over 181,000 people in 162 countries have already been diagnosed with COVID-19, and more than 7,000 deaths have been attributed to the highly contagious viral disease as of March 16, 2020.

About Fluxergy

Fluxergy LLC, founded in 2013, is an innovative medical diagnostic solutions start-up funded by Kingston Technology co-founder John Tu. Fluxergy's solution is a testing platform based on three core elements: the single-use consumable Fluxergy Card, the Fluxergy Analyzer, and its user interface Fluxergy Works. Fluxergy's mission is to provide a portable and highly sophisticated sample-to-answer point-of-care platform that enables clinicians to cost-effectively conduct a wide range of multiplex and multimodal in vitro diagnostic tests (different types of tests all at once, up to 30 targets), utilizing a single small sample.

The Fluxergy system is designed to deliver test results within one hour (15-60 minutes depending on the test). The Fluxergy Analyzer and the single use consumable Fluxergy Cards are designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing technology and microfluidics. Leveraging Fluxergy Works Software, as many as 256 Fluxergy Analyzers can be managed with one local server and be linked in addition to the cloud.

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