Decision Diagnostics Corp. through its subsidiary Pharma Tech Solutions, Inc. the manufacturers and design specifiers for the GenViro! Covid-19 :15 test professional Swift Kit, announced that it received detailed media coverage for its individual home testing version of the Swift Kit.
Tuesday, May 12, 2020 9:10 AM EDT
WCBS-TV REPORT BY CHIEF HEALTH AND MEDICAL REPORTER DR. MAX GOMEZ, ALSO PICKED UP ON YAHOO NEWS, THEREBY REACHING A TOTAL AUDIENCE OF OVER 13 MILLION
LOS ANGELES, CA / ACCESSWIRE / May 12, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc. the manufacturers and design specifiers for the GenViro! Covid-19 :15 test professional Swift Kit, today announced that it received detailed media coverage for its individual home testing version of the Swift Kit. 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. The story can be viewed in full at https://newyork.cbslocal.com/2020/05/05/coronavirus-covid-19-decision-diagnostics-testing/
“Recognition from leading health and medical media is exactly what we want to more quickly build momentum toward testing that will be critical in helping the country get back to work,” said CEO Keith Berman. “While we continue to wait for the FDA to APPROVE last issue in our testing protocol, even as we have begun the testing, it is important the public know through respected, independent third-parties in the media that true assistance in combatting the virus that has virtually paralyzed our country is being sought as quickly as possible TO answer the needs of individuals and businesses alike.”
Our GenViro! Covid-19 professional test kit is currently in the FDA EUA review process and we have received the Pre-EUA Acknowledgement letter from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Screening Kit. We have since submitted a similar, but more complicated application for our individual home testing kit. This new kit has also received an FDA Acknowledgement letter, for device (serial number) PEUA200947. With receipt of the PEUA letters, the FDA discloses that review staff is assigned to the application. We are especially hopeful of obtaining regulatory approval that will allow Emergency Use for our at-home GenViro! product, which we believe to have the greatest market appeal.
Health care officials and politicians recognize that large-scale, efficient and cost-effective testing is a critical component to allowing America’s work force to return to the work place. The key will be to test people, as best as possible and on the spot, employees returning to work while at the same time providing individuals with a way they can accurately test themselves for the virus at home. Employees and individual home testing is an essential remedy for controlling future outbreaks of the virus. Despite numerous claims and the fact that large players are positioning themselves as the “go-to” testing resource, today’s testing sources simply do not meet the requirements that are necessary for employees to keep themselves safe while also allowing employers safely to keep their businesses up and running or, in many situations, to resume operations with procedures in place that will entice employees to return to work. Immediate and accurate test results must be available.
PharmaTech Solutions “Swift Kit” testing kit is designed to provide the answers individuals and employers need. It is engineered to provide accurate results on the spot with no delay. While the FDA continues its assessment of how to move forward with this technology, the company is working with a health care products distributor who has already received numerous requests pending approval for the GenViro! Swift kits. This distributor, experts in disaster relief projects has received interest or verbal commitment from entities ranging from Fortune 50 corporations, to professional sports leagues, to large retailers interested in selling the GenViro! product, to offering the rodut in thousands of its pharmacies, to testing their own employees. The company at present estimates that if FDA approval is secured 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. Simply stated, the company and GenViro! have been introduced to major businesses in both the U.S. and Canada, who are ready to place orders as soon as the company is authorized by the FDA to proceed. When available, the “Swift Kit” is expected to provide an immediate, affordable highly precise way to identify those that are infected with the Covid-19 virus, thereby allowing Americans 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!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, and the product concept has been presented to officials in Washington, DC.
Forward-Looking Statements:
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of May 11, 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.
