COMPANY WILL DETAIL CURRENT PROGRESS OF FDA EUA WAIVER, FILING OF 2ND EUA FOR AT-HOME USE KIT, & HUGE RESPONSE FROM AMERICAN COMPANIES LOOKING TO BUY 1ST IN LINE
LOS ANGELES, CA / ACCESSWIRE / April 21, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc. the 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 will update shareholders and other interested parties on Thursday April 23 on issues concerning the progress of our GenViro! Covid-19 test kits as well as other company crucial business issues. Our GenViro! Covid-19 test kit is currently in the FDA EUA review process. We have received the Pre-EUA Acknowledgement letter from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Screening Kit.
Keith Berman, CEO of DECN commented, "We plan several updates for our GenViro! Covid-19 test kits as our EUA application progresses through the FDA. The first of these updates will be Thursday, April 23, 2020. In this update we will also speak at length about our sister product, the GenViro! for at-home use, where we are now in the process of completing our FDA EUA application. Also in our plans is a first time update of the overwhelming interest from large businesses and medical distributors looking to be first in line to acquire our GenViro! kits as the nation attempts to return to normalcy. Businesses, large and small, are attempting to implement their plans to test employees returning to work, in a regimen that will be employed over a 5-6 week period, time and again."
Mr. Berman continued, "Our discussion this coming Thursday will be longer than usual, and it will contain quite a bit of information, especially as we discuss the overwhelming response received from business and distributors for the purchase of the kits. We are overcome with optimism we are witnessing daily for this truly remarkable product."
Serology Testing for COVID-19
According to the Johns Hopkins School of Medicine, "Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen. Serology-based tests analyze the serum component of whole blood. The serum includes antibodies to specific components of pathogens, called antigens. These antigens are recognized by the immune system as foreign and are targeted by the immune response. These types of tests are often used in viral infections to see if the patient has an immune response to a pathogen of interest, such as influenza, or in this case COVID-19. These methodologies are a focus of current test kit methodologies, particularly what are called rapid kits, which are not very rapid, and not self-contained so therefore only a partial kit. These tests have been around at least since the 1980s. GenViro! is not a Serology methodology. GenViro! does not selectively look for antibodies.
PCR Based Testing for Coronavirus ("Take a Nose Swab")
PCR based (RNA) testing of virus and infections has been around since the early 1980s and make up a large number of methods used to detect Covid-19. For example the much discussed Roche methodology detects the genetic signature (RNA) of the SARS-CoV-2 virus in swab samples that a healthcare provider collects from the back of the patient's throat or nose. Most alternative methods work in the same manner. Test turn-around time, usually is 4 hours. However, the testing does not occur at the location where the nose swab is taken. Also, instrumentation needed to complete the tests and report them are expensive. Many feel that In the United States, the slow rollout of coronavirus PCR (nose swab) tests has been widely attributed to a combination of previously stringent FDA rules, and the slower, older methodologies. The DECN GenViro! kit does not employ a nose swab, rather it receives its small blood sample through a finger prick, is self-contained and disposable, does not require a hospital or clinical lab based instrument for analysis, and it only takes 15 seconds, a minute fraction of the nose swab tests.
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 by invitation.
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 20, 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
[email protected]
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.