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COMPANY ALSO PROVIDES UPDATE ON THE CURRENT TRAJECTORY OF ITS GENVIRO! COVID-19 PROFESSIONAL TESTING SWIFT KIT, FDA STATUS, MEDIA AND CONGRESSIONAL SUPPORT
LOS ANGELES, CA / ACCESSWIRE / April 23, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc. the manufacturers and design specifiers for the :15 GenViro! Professional Swift Kit for testing Covid-19 testing, today announced that it plans a second EUA submission for an individual home testing version of the GenViro! Swift Kit for home testing. Decision Diagnostics is an 18-year old, diabetes and now infectious 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.
In addition to the announcement of its home testing submissions, the company is also providing an update today on several other critical business objectives and milestones. Our GenViro! Covid-19 test kit is currently in the FDA EUA review process (more about this below). We have received the Pre-EUA Acknowledgement letter from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Screening Kit. In the next week we plan to ask the FDA through counsel, as other companies have, for a conditional but immediate EUA approval subject only to completion of testing. This conditional approval will replace the Pre-EUA designation and allow the company to begin large scale preparation of kits.
FDA Emergency Waiver (EUA) Progress
As previously stated, we were granted a Pre-UEA (PEUA) by the U.S. FDA on April 4, 2020, PEUA200323, for our GenViro! :15 Swift kit for the testing of Covid-19. The PUEA is the formal notification from the FDA that a file (product) is under review for EUA clearance, that a reviewer has been assigned, and that testing protocols have been exchanged.
Subsequent to this grant, we have had two long conversations with FDA staff and management, the first of these discourses between our FDA counsel and FDA staff, the second conversation, on April 14, 2020, between our FDA counsel, DECN management and DECN technical and product development professionals. The purpose of these calls was to clarify and differentiate our GenViro! Swift kit, Pro Version, from the myriad of antibody/antigen methodologies that our product has been inaccurately compared to, primarily in public, but not scientific forums.
Discussions with FDA staff and management have focused on the differences inherent to our Genviro! Swift product, those differences that add to GenViro!'s value in use. For example the FDA is concerned with reagent and sample contaminants that may be present during testing, primarily because the samples taken from a patient using current methods must travel from the site of the patient to a laboratory for assay. This travel at times takes hours, sometimes days. GenViro! Swift does not make use of any reagent to provide a result. Therefore there will be no sample contaminant. Also, the patient sample it makes use of, a small drop of blood, does not have to travel. In fact the assay and answer are provided on the spot, in 15 seconds, right in front of the patient. We believe we have completed discussions and have come to an understanding with the FDA on all of the testing required to receive the EUA. We plan to engage a specialty reference laboratory to complete this testing in the next 10 days. Testing should take about a week.
On April 13, 2020 the company engaged a publicist and a lobbyist. The publicist has engaged three media outlets, who have shown great interest in the story of GenViro! Swift and want to interview DECN CEO Berman. One has already run a short introductory description of the product and is preparing a longer, more involved segment and has already accepted a number of visuals from us for the report. It is interesting to note that the media outlets are well versed in Covid-19 testing methods and are excited about GenViro! Swift not just for its promise but also because it is so different and so much faster to report than other methods currently available.
In addition, the company's lobbyist has engaged several influential members of Congress who have spoken at length with the company and its representatives. The Congressmen have agreed to carry the ball on behalf of the company, beginning with direct communication with the Pence Covid-19 Task Force. This process began on April 20. The company's goal for GenViro! is not just to receive EUA approval from the FDA, but when this approval is received, to become the go-to testing solution, in demand by Professional organizations as well as Fortune 500 companies, even sports teams.
New markets for our GenViro! have also been recently identified, the latest -- large businesses, Fortune 500 companies, seeking to reopen for business in the next month or two. This is perfect timing for the availability of kits. Some of these businesses have already contacted the company and even tried to place large purchase orders for GenViro! Swift kits, using the first in line principal, so that they may test and retest returning employees. No other test kit can accomplish this. The company has also accepted inquiries from restaurant chains and drinking establishments -- places where people congregate. We believe an outgrowth of this new market will be that off-duty nurses, medical technologists licensed to draw blood, and off duty pharmacists will be in large demand. The company has even been contacted by a sports franchise/league for the testing of players and ticket holders.
GenViro! for At-home (Individual) Use
Our original plan for GenViro! was to offer a single kit containing two PFUs (user's guide), one for Professional Use, one for at-home individual use. Otherwise, the contents of the kits were identical --- 3-test strips, 5-lancets, 1-check strip. However, as March moved into April it became clear that the FDA was not approving individual at-home use kits. So in order to move its application along within the EUA review system, DECN removed all of the description and data owing to the individual at-home kit. And now we bring it back -- by demand.
On April 21, 2020 the FDA approved an at-home sample collection device for Covid-19 testing, allowing individuals to purchase the collection kits, collect their own samples and then use the mails or other package service to deliver the sample to a laboratory for assay. Oftentimes government moves slowly, but they also tend to build large doors and then open them. DECN views this as an opportunity to become the first company to provide an all-in-one, immediate result, individual at-home Covid-19 test kits with its GenViro! Swift kit for at-home use. We intend to file our stand-alone EUA application for the individual use GenViro! Swift kit by May 1. We anticipate the application to include data gleaned from our GenViro Professional kit application. We also anticipate a request to direct us to conduct a donor study of a modest group of donors. We have already identified a group in Pennsylvania to make use of the Genviro! Swift Home kit. Additional testing required for this kit is anticipated to take less than a week.
Unanticipated Large Response from Large Corporations
A question that has been on everyone's mind has been how will America go back to work. On April 20, the company engaged Universal Response LLC to manage the sales we expect from the transitioning of the country from shelter in place guidance to a back to work environment. Customers that the company has been introduced to are ready to place orders.
The key will be to test, as best as possible and on the spot, employees returning to work while at the same time providing individuals with a way they can test themselves for the virus at home. Employees and individuals testing at home and at work is a remedy for controlling the impact of the virus. Current testing methods simply do not meet the requirements that will be necessary for employees to keep themselves safe and also allow employers to keep their businesses up and running. Without immediate results, testing just won't work the way it must.
PharmaTech Solutions GenViro! "Swift Kit" testing kit will provide the quick answers individuals and employers need. It provides results on the spot with no delay. While the FDA assesses how to move forward with this technology, the company is moving to work with a large health care products distributor who has already received requests for the GenViro! Swift kits. Outlets ranging from Fortune 50 corporations to professional sports leagues have shown strong interest. The company estimates it will be asked to produce 1 million "Swift Kits" per month through the end of the year just for the "back to work" markets, based on the rapidly building demand.
FDA authorization for a test of the technology is more warranted than ever as demand for the "Swift Kits" rapidly expands. When available, the "Swift Kit" will provide an immediate, affordable and sure way to identify those that are infected with the Covid-19 virus and allow American's to get back to work.
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!™ 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, and the product concept has been presented to officials in Washington, DC and members of Congress by invitation.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of April 22, 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.
SOURCE: Decision Diagnostics Corp.
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