Includes International Distribution Status, Professional Video Finalized, XPRIZE Contest Next Steps, Manufacturing and Signed Testing Partner Updates
LOS ANGELES, CA / ACCESSWIRE / October 13, 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 "Progress Update" on its continuing efforts to secure FDA EUA approval for its Covid-19 Saliva Swift Kit antigen test, its international distribution status and other company developments.
Late last month the company announced it had signed an agreement with an FDA and CLIA certified US-based testing partner to undertake a feasibility study together with 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 lab results will be included in DECN's upcoming FDA EUA applications which are expected to be filed in Q4 2020. The company plans for parallel applications with the EU and Russian Federation, as it continues its international efforts to make its detection technology available globally.
"Based on the testing conducted by our Korean partner, we have every reason to believe that our US testing partner will see similar results and report that GenViro! meets (and is likely to exceed) the FDA requirements to earn EUA approval," said CEO Keith Berman. "We are encouraged by the progress and pace the company is seeing on a variety of critical fronts and remain focused on bringing each to a successful conclusion as swiftly as possible to further our overall goals of bringing this promising testing solution to markets globally."
In addition to the upcoming FDA testing, the company announced it has received its first written purchase order from an Indian distributor. The first of several expected follow-up orders turned out to be substantially larger than initially reported, and is comprised of 500,000 Genviro! Saliva Swift Kits, 50,000 GenViro! Swift Verify Kits and 7,500 GenViro! Swift Kit Meters. The company expects manufacturing to commence shortly and additional opportunities for product distribution in Malaysia, Indonesia, the Russian Federation and EU are in the works.
As the distribution and manufacturing efforts advance, the company also reported it had completed two critically important professional use instructional videos that will accompany the GenViro! Covid-19 Saliva Swift Kit to market in the US and internationally. The videos provide step-by-step instructions for professionals to follow to obtain the most accurate results with each and every test. Videos are currently being prepared in English, as well as with sub-titles in Russian, German, French, Spanish and Hindi, with further adaptations of the video in Bahasa Melayu. Videos are posted on the Pharma Tech Solutions, Inc. web site: https://www.pharmatechsolutions.co/genviro.html
As the signing of a US testing partner was being secured, and with extensive testing already undertaken and continuing in Korea, DECN will also advance to a third round of testing in Korea in conjunction with the company having been selected as a semi-finalist for the 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 organization 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 blood, which approximates a non-infected sample, and contrived blood which approximates COVID infected samples, which samples will be 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 the Grand Prize Winners in Q1 2021.
Finally, the company confirms that it will initially make three retail products available for international professional use: First, GenViro! Saliva Swift Kit consisting of 1 test strip, an interface sleeve adapter, one saliva collection vessel, diluent, package inserts that will be priced at $8.95 wholesale with an MSRP of $29.95. The GenViro! Swift Kit Meter will include 1 meter good for up to 100 test readings, an instructional video on computer media, which can also be accessed at the web site www.pharmatechdirect.com, a meter user's guide manual, and package insert. The meter will wholesale for $19.95 with an MSRP of $39.95 and will include a user's manual, package insert and the aforementioned DVD containing the company's GenViro! instructional videos. The GenViro! Swift Verify Kit will include 1 test strip, an interface sleeve adapter and package insert. This kit is designed to provide a follow up Covid-19 test should that be desired. The GenViro! Swift Verify Kit will be priced at $6.95 wholesale with an MSRP of $24.95.
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 $15+ billion at-home testing market.
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 partner 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 [email protected].
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of October 12, 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.
For Decision Diagnostics Corp.
SOURCE: Decision Diagnostics Corp.