FLUXERGY Reaction Mix COVID-19

Test Summary

The Fluxergy Analyzer system is a test platform designed for multiplex, multimodal * testing. The Fluxergy CoVID-19-Sample to-Answer-RT-PCR Test, which uses state-of-the-art PCR and microfluidic technology, has been shown to identify the SARS-CoV-2 virus in less than one hour in laboratory tests performed both by internal studies and in follow-up validation tests with patient samples from researchers at the University of California, San Diego (UCSD).

• Real-time RT-PCR
• Direct sample format (no nucleic acid extraction required)
• Sample: nasopharyngeal swab in UTM / VTM transport medium
• Aim of the test: SARS-CoV-2 nucleocapsid gene (N gene) and polyprotein gene (orf1ab)
• Simple workflow: swirl sample in transport medium, pipet sample into reaction mix, and pipet into test card

FDA Status

Validation data was submitted to FDA as part of Fluxergy’s application for Emergency Use Authorization (USA) on March 28 of 2020. Fluency products are for Research Use Only (RUO) and not for diagnostic procedures. Fluxergy products are not yet approved by the FDA or USDA for in vitro diagnostic use. None of these statements has been endorsed by the FDA or USDA. Fluxergy does not currently sell products for human or food use.

Combined PCR And Serology Test

Fluxergy is working on the rapid development of a combination PCR test and serology. This test is designed to give two pieces of information about a patient, whether the virus is present today, as well as the immune response.

• Samples: nasopharyngeal swab in transport UTM / VTM media for RT-PCR. Finger pricking whole blood or plasma for AFL
• Direct sample format (no nucleic acid extraction)
• Sample: nasopharyngeal swab in UTM / VTM transport medium
• Test objective: SARS-CoV-2 nucleocapsid gene (N gene) and the polyprotein gene, orf1ab.

Syndromic PCR Panel

Our syndromic panel, currently in our development pipeline, is designed to be able to differentiate between the presence of SARS-CoV-2 and influenza (common flu) and other respiratory pathogens. We anticipate that our syndromic panel will be incredibly valuable during flu season.

Greater Manufacturing Capacity

On May 13, 2020, Fluxergy announced a $ 30 million investment in manufacturing our diagnostic platform in response to the COVID-19 pandemic. We anticipate that our significant investment to intensify our manufacturing. The capacity will allow Fluxergy to perform up to one million tests per month and reflects our confidence in our technology as an important and innovative solution to expand COVID-19 testing capabilities.

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