Umbra Applied Technologies Group, Inc. and strategic partner, Bacter Scientific, Inc. announced that the Office of In Vitro Diagnostics and Radiological Health and Office of Product Evaluation and Quality within the U.S. Food and Drug Administration (FDA) accepted the company’s request for a Pre-Emergency Use Authorization (PEUA). The FDA’s Division of Program Operations and Management team has conducted and concluded its preliminary review of the Novi hand-held point-of-care test for the qualitative detection of novel coronavirus (COVID-19). The proprietary hand-held virus detection unit is now in queue for “substantive review” to be approved for emergency use. Once approved under Emergency Use Authorization (EUA), the Novi device will be the fastest and most accurate and only hand-held point-of-care genetic virus test available, for the detection of novel coronavirus (COVID-19). The unit has the potential to deliver positive results in as little as five minutes. The test will utilize Loop Mediated Amplification (LAMP) within a proprietary bifurcated sample tube to amplify and test the virus DNA. The device will run redundancy throughout the entire testing process, essentially running two tests simultaneously on each sample to ensure the most accurate results in minutes. This mobile platform will provide rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics, first responders and hospital emergency departments. Additionally, the device can be operated at home, by non-clinical persons as well as schools, airports, transportation hubs and law enforcement. The Novi platform is small, lightweight (9 oz), portable (slightly larger than a cell phone), and uses technology already approved as well as in use to detect infectious disease. The United States Department of Agriculture (USDA) has chosen a device that utilizes LAMP, as the primary method to be used by the Food Safety and Inspection Service (FSIS) in testing for Salmonella and Listeria monocytogenes, two serious pathogens that put food at risk during production and processing. The technology is common place and highly accurate but, has been bulky and impractical as a portable technology until now. In addition to the EUA process the Company has begun the process to file a 510k. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). In accordance with this process, Bacter Scientific is reviewing CLIA labs to conduct third party testing of live pathogens to be provided by the CDC and FDA. This will enable the company to continue delivering the Novi as an FDA approved device far after the official Covid-19 pandemic is over. Future iterations of the fully automated high-tech device, already under development, will feature a slimmer design that will deliver faster test results with the same projected accuracy of 98% or higher. The second-generation device will accept virus reagent specific testing tubes and have the capability to screen for various respiratory dwelling viruses such as COVID-19, MERS, TB, Zika Virus, Influenza variants, Human Metapneumovirus and many others. The company has submitted and continues to submit U.S. and International Patent protections for 42 Intellectual Property claims associated with the high-tech device. The company is set to conduct a series of studies required by the FDA for Emergency Use Authorization (EUA) testing for its COVID-19 assay in a point-of-care (POC) environment using the hand-held Novi platform implementing LAMP. This is significant because the majority of other testing systems that have been submitted for this designation can only be used by highly trained personnel, whereas Novi, with its automated user-friendly interface, would allow for little to no training. The company has already prepared production of 500,000 units for immediate delivery once approved and will be making the Novi device initially available to healthcare providers, schools and law enforcement with home units being delivered shortly thereafter. The company is prepared and expects to deliver three million units in the first year of production with production ramping up year over. The company estimates the retail price of the Novi device to be $499.99 for the professional use model and $199.99 for the in-home device. Each sample collection testing tube is projected to cost between $10-$20 USD making the Novi testing device the lowest cost per test currently available.