DECN Provides Update on Accomplishments and Pathway to Securing FDA EUA Approval for its COVID-19 "Transmission Indicating Testing" Methodology

Rhea-AI Summary

Decision Diagnostics Corp. (OTC PINK:DECN) has made significant progress towards FDA EUA approval for its Covid-19 GenViro! Swift Kit testing methodology. The company is collaborating with a Korea-based partner to finalize saliva and blood rapid testing kits. DECN is now selecting US testing labs and is in discussions with the LA Mayor's Covid-19 Task Force to enhance at-home testing. Preliminary results from Korea indicate high accuracy with less than 5% variance in known-negative tests. The company expects to submit a new FDA application by the end of September.

Positive

• Collaboration with Korean partner indicates strong international testing capabilities.
• Preliminary testing results show less than 5% variance, exceeding FDA accuracy requirements.

Negative

• None.

Includes information about US-based testing partner selection, work with LA Mayor Covid-19 Task Force, initial known-negative testing results from Korea

LOS ANGELES, CA / ACCESSWIRE / August 26, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, a leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters through its subsidiary Pharma Tech Solutions, Inc., today provided the following "Update" on its effort to produce a Covid-19 Swift Kit antigen testing methodologies and secure FDA EUA approval for its products. The company has been working diligently with its Korea-based testing and product development partner to perfect both saliva and blood Covid-19 rapid testing Swift Kits, whose foundation is based on a modified test strip and meter reader technology that the company has been manufacturing and distributing with its diabetes monitoring products.

"As the experts have pointed out, the country needs to change its testing platform in order to identify people when they are most infectious, and while at the same time potentially being asymptomatic, and that's what our Genviro! Saliva testing products are designed to do," says DECN CEO Keith Berman. "Important advancements have been made toward selecting a lab, or perhaps two labs, to do our US-based testing on our saliva methodology that we believe should be more readily accepted by the FDA, and eventually by individuals for at-home use as it is completely non-invasive. We have engaged a special consultant to expedite this process, and as a result he recently introduced us to a third laboratory located on the east coast. Our decision is now between two laboratories associated with major university hospitals and a third reference laboratory currently involved in its own (non-competitive) EUA in process. All three laboratories deal with saliva based methods. The two laboratories associated with university hospitals already have approved EUAs through the FDA. However, none of these laboratories offer methodologies that provide results as expeditiously as our GenViro! Swift Kit that has recorded lab test results in (10.5 seconds), and, even more significantly, offer true point of care testing. As discussed previously, the GenViro! Swift Kit will be tested in two phases; the first phase providing results to assist the company in seeking approval in the EU, Russian Federation and the ten other nations where we have signed distributor agreements. The second phase testing will be for the FDA EUA authorization.

Beyond selecting its testing partner(s), the Company is now discussing opportunities for pilot program participation with Los Angeles Mayor Eric Garcetti's office, which has been among the most aggressive in pushing for faster and simplified at-home testing methods as the virus has hit California with particular fury. That potential relationship would have us working directly with the University of Southern California, which is overseeing most of LA's pilot programs.

The company is now also finalizing the software updates and algorithms for its GenViro! Swift Kit testing meters that will test (read) the saliva provided by a human donor. No changes were required to the GenViro! test strip which has the capability to work with whole blood, blood plasma and saliva. Upon completion of US-based testing with the about-to be-selected lab partner, the finished GenViro! Instructional Package Insert (IPI) and soon to be completed video will be submitted in conjunction with the new FDA application. The company expects all this to occur prior to the end of September.

"We will also seek to share some testing data as it becomes available from our Korean partners. Right now we are reviewing exceptional accuracy in our testing as well as reproducibility, with impedance values across the entire spectrum of human donors showing less than a 5% variance. Our Korean partners' tests of known negative patients has exceeded what the FDA guidance states. While this is the first such data to come in, GenViro! is operating at a level well above what is currently required by the FDA and beyond what experts such as Harvard's Dr. Michael Mina are saying should be necessary for simple, rapid testing that he says, ‘provides the transmission indicator testing needed'. We expect additional data to arrive shortly," said Berman.

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.

Forward-Looking Statements:
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of August 25, 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.

View source version on accesswire.com:
https://www.accesswire.com/603353/DECN-Provides-Update-on-Accomplishments-and-Pathway-to-Securing-FDA-EUA-Approval-for-its-COVID-19-Transmission-Indicating-Testing-Methodology

FAQ

What is Decision Diagnostics Corp's stock symbol?

Decision Diagnostics Corp's stock symbol is DECN.

What progress has DECN made toward FDA approval for its Covid-19 testing kit?

DECN is finalizing its Covid-19 GenViro! Swift Kit and expects to submit a new FDA application by the end of September.

Which lab partners is DECN considering for US testing?

DECN is selecting between two university-associated labs and a third lab for saliva-based testing.

What are the expected benefits of DECN's Covid-19 testing methodology?

The GenViro! Swift Kit promises rapid results in about 10.5 seconds and offers non-invasive testing.

How accurate are the initial testing results from DECN's Korean partners?

Initial results show exceptional accuracy, with a variance of less than 5% in known-negative tests.