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We propose to develop a rapid (under 20-minute), point-of-care (PoC) Reverse Transcriptase Loop-mediated Amplification (RT-LAMP) test for the detection of SARS COV-2 virus from human nasal and oral swab and saliva samples.

Our SARS-CoV2 RT-LAMP assay will be implemented on our Novel Dx system which comprises an easy-to-use, affordable, ultraportable instrument that performs a fully-automated nucleic acid amplification test (NAAT) on a self-contained, disposable, test-specific cartridge.

Development of this assay will enable SARS CoV-2 testing to be performed in lab-free healthcare settings such as CLIA-waived clinics and physician offices as well as in non-healthcare settings including offices, retail centers, airports and homes.

In addition to the development and implementation of a SARS COV-2 RT-LAMP assay on our NovelDx instrument/cartridge system for point-of-care and lab-free settings, the developed LAMP assay will itself be made available for implementation in labs as a mid-to-high throughput SARS-CoV-2 testing solution.

Doing so will greatly increase U.S. capacity for and accessibility to SARS-CoV-2 testing by enabling rapid, highly sensitive and specific isothermal molecular tests to be performed in basic laboratories not otherwise equipped for typical PCR thermocycling-based nucleic acid analyses.

Analytical and Clinical Studies on the Novel Dx SARS-CoV-2 test will be performed as per the FDA Emergency Use Authorization (EUA) Guidance, to obtain use authorization.

Subsequently we aim to develop a multiplex Flu-A/Flu-B/SARS-CoV-2 assay to detect and differentiate between Influenza and COVID-19 infections.

We plan to submit a dual 510(k) and CLIA waiver application for marketing the Novel Dx Flu-A/Flu-B/SARS-CoV-2 test to US healthcare facilities.