Company Adds a Second Impedance Channel to the Genviro! Test Strip, Correcting For Blood Hematocrit, Resulting in an Expected 30% Improvement in Reporting Time
LOS ANGELES, CA / ACCESSWIRE / June 17, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today announced it has filed a provisional patent for its Genviro! Swift Professional product titled, “Method and Apparatus for Swift Determination of the Covid-19 Virus.” In so doing, the company is unveiling its Hematocrit adjustment feature, initially developed for its GenUltimate TBG system. When incorporated into the GenViro! System it will offer testing results available to the administrator of the kit with an expected 30% improvement in result reporting time than the current testing time of :15 seconds, while at the same time adjust for issues involving an abundance of, or an insufficiency of, red blood cells in a patient blood sample. The company will document this improvement in its previously announced FDA EUA Addendum II filing. DECN’s Pharma Tech Solutions subsidiary first submitted its GenViro! professional use device to the FDA on April 3, 2020.
Specifically, the addition of the Hematocrit (HCT) adjustment feature will be used during each testing phase of the GenViro! test kit, to adjust for an abundance of, or an insufficiency of, red blood cells, and in turn will yield three benefits: 1) the exclusion of the need for a chemical lysing solution and its intricacies, 2) with the addition of our TBG technology we will mathematically correct for the hematocrit effect, which can interfere with electronic readings, and in doing so, 3) the TBG technology will further lower the time required for a completed Covid-19 test result by an anticipated 30%.
Such an addition makes the Covid-19 result virtually immediate. In fact, it will take longer to open the kit package and extract a GenViro! Swift test strip and to draw a finger-tip drop of blood than it will to administer the test itself. The company expects its kit availability schedule to remain unchanged with delivery outside the US commencing as early as during the summer months, and with US and North American commerce commencing shortly after FDA authorization.
Along with the provisional patent related to Covid-19, the company will also be filing a second provisional patent for its GenUltimate TBG system under the title, “Method and Apparatus for Enhanced Blood Glucose Measurement.” This filing represents the technical memorialization of and protection for its panacea glucose testing product, the product that first made use of our TBG hematocrit adjustment technology.
Keith Berman CEO of DECN commented, “With the addition of the Hematocrit adjustment feature we are uniquely positioned to provide what amounts to nearly instant Covid-19 test results, something we desperately need as pockets around the globe face what looks as though it could be a second wave of the virus. All experts agree it is critical to identify those who are currently infected to protect those who are not.
The company had previously announced that separate Emergency Use Applications (EUA) had been filed and that it had received Pre-EUA Acknowledgement letters from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Swift Kit for professional use in commercial and group settings and device (serial number) PEUA200947, GenViro Covid-19 Screening Kit for at- home use.
Decision Diagnostics through its Pharma Tech Solutions, Inc. subsidiary is an 18-year old diabetes testing products 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. Subject to FDA authorization of its GenViro! Swift kits, DECN anticipates adopting its further developed impedance technology, first utilized for its diabetic testing products, to implement the manufacturing and distribution of its GenViro! Covid-19 :15 Swift test kits in the U.S., Canada, and worldwide.
Mr. Berman continued, “With these new developments and as great a sense of urgency as we have faced to date, we finally anticipate action from the FDA. We have recently received a written commitment for the distribution of our GenViro! Swift Kits from a previously mentioned distributor who will represent us in India, Singapore, Malaysia and Indonesia, and in recent negotiations we have come to agreement on distribution of GenViro! Swift kits in Thailand, Vietnam, Nepal, Bangladesh, Sri Lanka, and Australia. This distribution agreement is not exclusive to this distributor. As part of the usual and customary agreement process, which will require import certificates, country tax stickers etc., we will also require unit forecasts. All prospective sales will be in U.S. Dollar denominations. We will have further discussions in subsequent announcements.”
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 newly 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 Covid-19, is not yet available in the United States or Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of June 16, 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.
Decision Diagnostics Corp.
Keith Berman (805) 446-2973
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