UAT Group Affiliate, Bacter Scientific to File 510(k) While Awaiting EUA Approval
Umbra Applied Technologies Group (UATG) announced that its strategic partner, Bacter Scientific, has received FDA acceptance for a Pre-Emergency Use Authorization request for its Novi COVID-19 testing device. The Novi's point-of-care test can deliver results in five minutes, is portable, and requires minimal training to operate. The company anticipates production of 500,000 units ready for immediate delivery post-approval and expects to offer 3 million units in the first production year. The device will cost $499.99 and aims to be the lowest cost per test in the market.
- FDA acceptance for Pre-Emergency Use Authorization for the Novi device.
- Potential for rapid results in 5 minutes with high accuracy.
- Plans for immediate production of 500,000 units upon approval.
- Estimated retail price positions Novi as the lowest cost per test in the market.
- None.
Austin, Texas, July 13, 2021 (GLOBE NEWSWIRE) -- Umbra Applied Technologies Group, Inc (OTC Pink: UATG) Affiliate and strategic partner, Bacter Scientific, Inc., a privately held, molecular diagnostics and infection detection medical research company, announced today 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 today 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
UAT Group Chairman, Alex Umbra stated, “Over the past year we have worked tirelessly with our partners to develop the most reliable and accurate virus testing device soon to be available. In an effort to deliver the highest quality medical device long after this pandemic is over, we have begun the process to gain FDA approval for the long-term. There are many known viruses with the potential of causing harm to humans and we have learned that testing and detection are the front lines in which lives will be saved. This pandemic is one battle in what will most likely be many fought against infectious disease in the future and our organization stands ready to respond to with the most advanced cutting-edge technology available “.
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
Umbra further commented, “The Novi’s cost per test will be the lowest in the industry making it more accessible to the masses. This cost-effective approach to screening and detection is how the war against the spread of infectious disease will be won on the front lines of this and future pandemics. This is something we are especially proud of and will continue to drive towards retail delivery”.
For more information about Bacter Scientific, Inc. visit: http://bacterscientific.com
For more information, visit www.uatgroup.com
Investor and Media Contact: UAT Group at: info@uatgroup.com
About Bacter Scientific, Inc.
The company is located in Austin TX and is a medical device manufacturer and research company based in Austin, Texas specializing in the development of products that detect and prevent infection in clinical, commercial, industrial and residential environments
For more information, visit www.bacterscientific.com
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Forward-Looking Information
This news release may include "forward-looking statements" including forecasts, estimates, expectations, and objectives for future operations including but not limited to its ability to conclude a business combination with a third party, sale of assets, return of capital or initial public offering and/or a secondary listing as a result of aforementioned and its ability to fund the exploration of its assets through the raising of equity or debt capital or through funding by a joint venture partner that are
subject to a number of assumptions, risks, and uncertainties, many of which are beyond the control of Bacter Scientific including but not limited to capital markets and securities risks and continued development success on technology. There can be and are no actual or implied guarantees that any of the above activities will be completed or completed on terms acceptable to the Company and its shareholders or approved by any regulatory authority having jurisdiction. Such forward-looking information represents management's best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Bacter Scientific does not assume the obligation to update any forward-looking statement, except as required by applicable law.
FAQ
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