DECN Signs Agreement With US-Based Laboratory as Testing Partner for Genviro! Saliva Swift Kit Testing for Additional FDA, EU CE Mark and Russian Federation Submissions

Rhea-AI Summary

Decision Diagnostics Corp. (OTC PINK:DECN) has partnered with a FDA & CLIA certified laboratory to initiate testing for the Genviro! Saliva Swift Kit. The results are expected to facilitate applications for FDA Emergency Use Authorization and European Union CE Mark certification, as well as submissions in the Russian Federation. The company aims to expedite market entry, with preliminary international orders already received. Moreover, DECN is participating in the XPRIZE Rapid Covid Testing competition in Korea, aiming for recognition in November 2020.

Positive

• Partnership with FDA & CLIA certified lab for Genviro! testing.
• International product launch commenced with first orders received.
• Participation in XPRIZE competition may enhance credibility.

Negative

• No current FDA EUA or EU CE Mark authorization for Genviro! product.
• Competition may pose challenges in securing market position.

FDA & CLIA certified laboratory will begin the testing of the Genviro! 10.5 Sec. Saliva Swift Kit, with full results expected to be reported to regulators in USA, EU and Russian Federation, and will also be included in the Genviro! Swift package inserts

LOS ANGELES, CA / ACCESSWIRE / September 30, 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 announced it has signed an agreement with a certified US-based testing partner to undertake a feasibility study as well as required testing for FDA EUA and European Union CE Mark certification as well as with the Russian Federation for submission of the Genviro! Covid-19 Saliva Swift Kit. The company expects the lab to report its results to DECN, who will include these results in their upcoming FDA EUA applications in Q4 2020, as well as parallel applications with the EU and Russian Federation, as DECN continues its international efforts to make its detection technology available globally. The international product launch commenced on September 26, 2020 at the pricing previously announced. A large first order has been received.

"Coming on the heels of the announcement of having our first international distributor order in place as of September 26, 2020, I am encouraged that the signing of a testing partner in the US will accelerate our efforts to get the Genviro! Covid-19 testing technology authorized by the FDA and in the US market," said CEO Keith Berman. "Initially slated to be tested for professional use, once we secure FDA authorization we will make the push for our individual at-home use that requires much the same testing. That is what we and the rest of the world truly want to see. In anticipation of this, our instructional videos which we are distributing to the international markets were completed for both professional and at-home individual use. As I have repeatedly stated, the test strip and meter reader testing modality, upon which our Covid-19 testing technique is based, has been used by diabetics to test themselves worldwide for years, so we have every reason to believe that the GenViro! Saliva Swift Kit will be readily accepted in the professional and individual user testing marketplaces for truly rapid Covid-19 testing anywhere, anytime."

In addition to the signing of a US testing partner and extensive testing already undertaken in Korea, DECN is going to begin a third round of testing in Korea as a semi-finalist participant for the respected XPRIZE, www.xprize.org. XPRIZE is the world's leader in designing and operating incentive competitions to solve humanity's grand challenges. It operates in collaboration with OpenCovidScreen, a non-profit founded by scientists and business leaders, to drive needed innovation through "Open Science". XPRIZE, OpenCovidScreen and a coalition of partners call on the global community to develop frequent, fast-turnaround, reliable, and easy-to-use screening tests to detect Covid-19 occurrences before they become outbreaks. The $5 million XPRIZE Rapid Covid Testing competition is designed to accelerate the development of high-quality Covid-19 testing that is low cost, accurate, easy to use, and provides a fast-turnaround, enabling frequent testing.

To meet the XPRIZE requirements, DECN will be testing samples containing both contrived, non-infected and contrived infected samples supplied by the organization. The samples will be shipped to Korea for testing and the results will be available once the XPRIZE committee announces its winning selection. The organization expects to report finalists in November 2020 and Grand Prize Winners in Q1 2021.

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. On September 26, 2020 the company began the launch of its International package versions of its GenViro! Swift Kit and Swift Meter. In addition, the company reports that its international distributor for the Russian Federation will be taking on the Genviro! products, will handle registration for emergency use approval in the Russian Federation, and has requested a non-exclusive agreement or waiver for expansion into the European Union as well.

Forward-Looking Statements:

This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of September 29, 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.
info@decisiondiagnostics.co
sdoniger@bdcginc.com
Twitter: @covidswiftkit
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com

SOURCE: Decision Diagnostics Corp.

View source version on accesswire.com:
https://www.accesswire.com/608412/DECN-Signs-Agreement-With-US-Based-Laboratory-as-Testing-Partner-for-Genviro-Saliva-Swift-Kit-Testing-for-Additional-FDA-EU-CE-Mark-and-Russian-Federation-Submissions

FAQ

What testing is Decision Diagnostics conducting for the Genviro! Saliva Swift Kit?

Decision Diagnostics is conducting feasibility studies and required testing with a certified lab for FDA EUA and EU CE Mark certification.

When are the results expected for the Genviro! Saliva Swift Kit testing?

Results are expected to be reported in Q4 2020.

Is Decision Diagnostics participating in any competitions related to Covid-19 testing?

Yes, they are participating in the XPRIZE Rapid Covid Testing competition in Korea.

What is the significance of the international product launch for DECN?

The international product launch signifies DECN's efforts to expand its market presence and has resulted in initial orders since September 26, 2020.

What regulatory approvals is DECN seeking for the Genviro! Saliva Swift Kit?

DECN is seeking FDA EUA, EU CE Mark, and Russian Federation approvals for the Genviro! Saliva Swift Kit.