DECN Announces Commencement of US-Based Donor Study for FDA EUA Guidance Testing for Their 10.5 Second Genviro! Saliva Swift COVID-19 Test Kits
Decision Diagnostics Corp. (OTC PINK:DECN) has commenced its donor study for the Genviro! Saliva Swift Kit, aimed at detecting Covid-19. This study is key for seeking FDA Emergency Use Authorization (EUA), EU CE Mark, and approvals in the Russian Federation. The company is confident that the saliva testing method will offer less invasive and more accurate results than previous blood tests. The results will support submissions to various regulatory bodies, with plans for completion in Q4.
- Commencement of donor study for Genviro! Saliva Swift Kit, targeting FDA EUA, EU CE Mark, and Russian regulatory approval.
- Saliva testing method is less invasive and expected to provide more accurate results, bolstering confidence in product efficacy.
- Company plans to complete submissions by Q4, indicating timely progress on regulatory approvals.
- Genviro! Swift Kits are not yet approved for sale in the USA or Puerto Rico, limiting current market access.
Donor Study Activities Began, Friday October 16th at FDA and CLIA Certified Testing Lab; Data to Also Be Used for EU CE Mark and for Emergency Approval in the Russian Federation Countries
LOS ANGELES, CA / ACCESSWIRE / October 19, 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 will begin its donor study as a precursor for its FDA EUA, EU CE Mark and Russian Federation testing of its Genviro! Saliva Swift Kit for the detection of Covid-19. The donor study, and eventual FDA guideline testing, will be conducted by the company's FDA and CLIA certified testing partner in the US.
"Our plans are on target for fourth quarter FDA EUA, EU CE Mark and Russian Federation submissions. The donor study is the launching pad for the work that needs to be done and early work is both encouraging and exceeding our expectations," said CEO Keith Berman.
"When the current rounds of testing are completed, will have had three series of tests from which we expect to hopefully obtain FDA authorization and to enable the U.S. professionals to be confident that GenViro! Swift results are as accurate as possible. EU CE Mark and Russian Federation applications, although both in similar emergency filing class as the FDA guidelines, follow a different, less stringent and hopefully quicker path to approval. We are further emboldened by the recent attention to the value and efficacy of saliva testing as both accurate and rapid, which is exactly what we have always sought from the Genviro! Saliva Swift Kit."
GenViro! Swift Kits are not yet approved for sale or distribution in the USA or Puerto Rico.
While the company's initial FDA EUA submission back in April involved its blood finger prick version of the GenViro! Swift kit, further advances brought it to the current saliva methodology that is both less invasive and according to recent studies is expected to be more accurate.
https://time.com/5891887/covid-19-saliva-spit-test/
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, and 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
The company's new GenViro!™ products designed to test for Covid-19 are not yet available in the United States or Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA with additional submissions to take place in the near future. The company has also signed an agreement with an FDA and CLIA certified US-based testing partner to complete testing per current FDA guidelines and continues to look forward to the FDA authorization of our EUAs.
The same data that will be produced by the company's new testing partner will be used for submissions to the EU and Russian Federation. We will also use data provided by our Korean R&D and contract manufacturing partner as part of their extensive product development schedule and as part of the XPRIZE initiative.
The company continues to recruit and accept applications from prospective domestic and international distributors. Inquiries can be directed to info@decisiondiagnostics.co.
Forward-Looking Statements:
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of October 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.
CONTACT INFORMATION:
Decision Diagnostics Corp.
info@decisiondiagnostics.co
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com
FURTHER CONTACT INFORMATION:
Decision Diagnostics Corp.
Shep Doniger
561-637-5750
sdoniger@bdcginc.com
SOURCE: Decision Diagnostics Corp.
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https://www.accesswire.com/610933/DECN-Announces-Commencement-of-US-Based-Donor-Study-for-FDA-EUA-Guidance-Testing-for-Their-105-Second-Genviro-Saliva-Swift-COVID-19-Test-Kits
FAQ
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