DECN Files Finalized FDA EUA Application for Its G
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Posted On: 04/06/2020 10:52:36 AM
DECN Files Finalized FDA EUA Application for Its Genviro! Covid-19 Swift Kit, Receives Notification of Acceptance From FDA After-Hours on Friday 4/3/2020
https://www.accesswire.com/583960/DECN-Files-...day-432020
DECN Files Finalized FDA EUA Application for Its Genviro! Covid-19 Swift Kit, Receives Notification of Acceptance From FDA After-Hours on Friday 4/3/2020
Monday, April 6, 2020 10:15 AM
FDA Further Assigns Genviro COVID-19 Swift Kit Application to EUA Review Group on Saturday 4/4/2020, Pre-Uea Designation Anticipated Next
LOS ANGELES, CA / ACCESSWIRE / April 6, 2020 / Decision Diagnostics Corp. (OTC PINK
ECN) manufacturers and design specifiers for the GenViro! Covid-19 Swift Kit, is an 18-year old, diabetes and now disease testing bio-technology development firm, high level manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for its own proprietary regulated medical devices, announces today that the company has filed its formal and finalized Emergency Authorization for its Professional Use Covid-19 screening kit with the Emergency Authorization review group at the U.S. FDA. The application was filed on Friday 4/3/2020 late in the afternoon, acknowledged less than three hours later, and assigned for EUA review on Saturday 4/4/2020. There have already been several contacts between the FDA EUA review group and the company's FDA counsel.
DECN had originally intended to submit its application for both of its Covid-19 Swift Kit products, the Professional version kit to be administered to by nurses, doctors, pharmacists and other professionals, and the at-home personal use kit we envision to be distributed by big box pharmacies, governmental agencies, home health agencies and directly by our own distributors. But because the FDA had yet to approve a kit designed for individual use, we decided to proceed first with the Pro version Swift kit and follow on as soon as possible with a separate EUA application for the at-home kit as a stand-alone application. We plan to use the same application with minor changes to reflect the individual use.
Keith Berman, CEO of Decision Diagnostics commented, "In February 2020, several weeks before the Covid-19 virus began to spread through Europe and then the USA, we prayed for our Korean colleagues who had the misfortune of living and working at Ground Zero for the Covid-19 virus in the city of Daegu. Watching that terrible news gave all of us the desire to open hearts, re-examine our past products and successes, all in an effort to create a diagnostic method based our own core technology competencies even though virus detection was not in our mainstream. I have always believed that our impedance based core technology, first used as a critical part of our GenUltimate TBG product in the fall of 2019, was an adjustable crescent wrench type tool with many and varied possible applications. The first result of our hard work is the Covid-19 Swift kit that will be administered by professional health responders.
We will continue with our stated practice to sell the kits in the wholesale markets for $6.95 each, each kit containing test materials and a back-up, in case of human test administration error. Our Swift kit will take a small amount of time to administer to a patient by a professional, such as poking a patient's finger-tip to achieve a drop of blood. Results will be available in about 15 seconds.
Mr. Berman continued, "Our Korean partners, my primary consultant, who came out of retirement to create the design drawings and commentary, our FDA lawyers, and our own employees and those of our Korean partner jumped all over our efforts in what became a fundamental initiative. The application we filed with the FDA last Friday is our first fulfillment of these efforts, after weeks of internal and external discussion, planning, designing and redesigning and finally completion of the method design. If April 3 is the date where we drove our product stake into the ground, then the new product was conceived, designed and readied for FDA EUA review in approximately 45 days. Our method is unique, minimally invasive, doesn't require a painful nose swab, and true to its trade name -- Swift."
The company plans additional releases for a further description of this FDA filing and review event, the first upcoming release to notify all interested parties when our EUA application is deemed Pre-UEA by the FDA, that seminal second step. We also plan a lay description of some of the unique properties of our method, to be described in detail to the USPTO in our upcoming patent applications, but in layman's terms for our interested parties which now include a number of foreign governments and/or their agents.
Mr. Berman concluded, "Work began in late March to incorporate the Covid-19 Pro kit into our overall QA Plan and the parallel QA plan of our partner in Korea. Work has begun lining up and ordering critical components needed for the methodology, such as the platinum glass electrodes. Given the Covid-19 crisis we find ourselves in, the flux in the rare earth and precious metals markets, delivery times for components have become much more important than price. Oh, and one last thing I am reminded of. The recent literature on the development of these tests, by us and other parties, has recently discussed President Trump's desire to have numerous "parking lot, drive up" testing centers in large retail, even church parking lots. The written accounts claim that these parking lot, drive up" testing centers have not materialized. In my humble opinion, while our Swift kits will have numerous uses in professionally administered settings, there is no better use for our Covid-19 Swift kit than these drive up centers, which we believe will quickly materialize."
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN's products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With new inspired technology diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company's new GenViro!TM product designed to test for the Coronavirus Covid-19, is not yet available in the United States or Puerto Rico but Emergency Waivers are in process. Now that we are a part of FDA review, and the product concept which had been presented to officials in Washington, DC is now part of the review and approval process.
Forward-Looking Statements:
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of April 4, 2020, regarding the company's business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.
CONTACT INFORMATION:
Decision Diagnostics Corp.
Keith Berman (805) 446-2973
info@decisiondiagnostics.co
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.
https://www.accesswire.com/583960/DECN-Files-...day-432020
DECN Files Finalized FDA EUA Application for Its Genviro! Covid-19 Swift Kit, Receives Notification of Acceptance From FDA After-Hours on Friday 4/3/2020
Monday, April 6, 2020 10:15 AM
FDA Further Assigns Genviro COVID-19 Swift Kit Application to EUA Review Group on Saturday 4/4/2020, Pre-Uea Designation Anticipated Next
LOS ANGELES, CA / ACCESSWIRE / April 6, 2020 / Decision Diagnostics Corp. (OTC PINK
ECN) manufacturers and design specifiers for the GenViro! Covid-19 Swift Kit, is an 18-year old, diabetes and now disease testing bio-technology development firm, high level manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for its own proprietary regulated medical devices, announces today that the company has filed its formal and finalized Emergency Authorization for its Professional Use Covid-19 screening kit with the Emergency Authorization review group at the U.S. FDA. The application was filed on Friday 4/3/2020 late in the afternoon, acknowledged less than three hours later, and assigned for EUA review on Saturday 4/4/2020. There have already been several contacts between the FDA EUA review group and the company's FDA counsel. DECN had originally intended to submit its application for both of its Covid-19 Swift Kit products, the Professional version kit to be administered to by nurses, doctors, pharmacists and other professionals, and the at-home personal use kit we envision to be distributed by big box pharmacies, governmental agencies, home health agencies and directly by our own distributors. But because the FDA had yet to approve a kit designed for individual use, we decided to proceed first with the Pro version Swift kit and follow on as soon as possible with a separate EUA application for the at-home kit as a stand-alone application. We plan to use the same application with minor changes to reflect the individual use.
Keith Berman, CEO of Decision Diagnostics commented, "In February 2020, several weeks before the Covid-19 virus began to spread through Europe and then the USA, we prayed for our Korean colleagues who had the misfortune of living and working at Ground Zero for the Covid-19 virus in the city of Daegu. Watching that terrible news gave all of us the desire to open hearts, re-examine our past products and successes, all in an effort to create a diagnostic method based our own core technology competencies even though virus detection was not in our mainstream. I have always believed that our impedance based core technology, first used as a critical part of our GenUltimate TBG product in the fall of 2019, was an adjustable crescent wrench type tool with many and varied possible applications. The first result of our hard work is the Covid-19 Swift kit that will be administered by professional health responders.
We will continue with our stated practice to sell the kits in the wholesale markets for $6.95 each, each kit containing test materials and a back-up, in case of human test administration error. Our Swift kit will take a small amount of time to administer to a patient by a professional, such as poking a patient's finger-tip to achieve a drop of blood. Results will be available in about 15 seconds.
Mr. Berman continued, "Our Korean partners, my primary consultant, who came out of retirement to create the design drawings and commentary, our FDA lawyers, and our own employees and those of our Korean partner jumped all over our efforts in what became a fundamental initiative. The application we filed with the FDA last Friday is our first fulfillment of these efforts, after weeks of internal and external discussion, planning, designing and redesigning and finally completion of the method design. If April 3 is the date where we drove our product stake into the ground, then the new product was conceived, designed and readied for FDA EUA review in approximately 45 days. Our method is unique, minimally invasive, doesn't require a painful nose swab, and true to its trade name -- Swift."
The company plans additional releases for a further description of this FDA filing and review event, the first upcoming release to notify all interested parties when our EUA application is deemed Pre-UEA by the FDA, that seminal second step. We also plan a lay description of some of the unique properties of our method, to be described in detail to the USPTO in our upcoming patent applications, but in layman's terms for our interested parties which now include a number of foreign governments and/or their agents.
Mr. Berman concluded, "Work began in late March to incorporate the Covid-19 Pro kit into our overall QA Plan and the parallel QA plan of our partner in Korea. Work has begun lining up and ordering critical components needed for the methodology, such as the platinum glass electrodes. Given the Covid-19 crisis we find ourselves in, the flux in the rare earth and precious metals markets, delivery times for components have become much more important than price. Oh, and one last thing I am reminded of. The recent literature on the development of these tests, by us and other parties, has recently discussed President Trump's desire to have numerous "parking lot, drive up" testing centers in large retail, even church parking lots. The written accounts claim that these parking lot, drive up" testing centers have not materialized. In my humble opinion, while our Swift kits will have numerous uses in professionally administered settings, there is no better use for our Covid-19 Swift kit than these drive up centers, which we believe will quickly materialize."
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN's products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With new inspired technology diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company's new GenViro!TM product designed to test for the Coronavirus Covid-19, is not yet available in the United States or Puerto Rico but Emergency Waivers are in process. Now that we are a part of FDA review, and the product concept which had been presented to officials in Washington, DC is now part of the review and approval process.
Forward-Looking Statements:
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of April 4, 2020, regarding the company's business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.
CONTACT INFORMATION:
Decision Diagnostics Corp.
Keith Berman (805) 446-2973
info@decisiondiagnostics.co
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.
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