As clinical testing in Pennsylvania nears completion for pro and point of care GenViro! kits, Korean partner initiates PCR validation testing to augment testing of their saliva donors and the XPRIZE samples
DECN plans 150 patient donor study to complete its at-home testing kit EUA
LOS ANGELES, CA / ACCESSWIRE / December 16, 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., as well as the designer and manufacturer of the GenViro! Covid-19 :10 test kits, today provided its most recent update about the multiple testing activities taking place domestically and abroad.
The company reported that its Pennsylvania lab testing is nearing completion, despite having been slowed by the resurgence in Covid itself. DECN's lab testing partner provides services in Pennsylvania and New Jersey but also has a large national mail-in business, offering testing of patients from all walks of life and across the U.S.
While the Covid resurgence has enhanced the overall ability to find Covid-positive candidates, at the same time it has also created a series of issues at the clinical lab itself that has stretched its human and clinical resources thin. Testing continues and preliminary results are indeed significant. The company is looking to provide a final FDA submission as soon as the Pennsylvania lab completes its work and its Korean partner completes the confirmatory PCR testing that began this week. DECN expects to submit data on many more samples than the FDA guidance requirement of the previously mentioned 30/75.
NOT YET AVAILABLE IN THE UNITED STATES OR PUERTO RICO
In addition to its US-based lab testing, the company and its Korean partner have moved to the next phase of testing. This phase is comprised of confirmatory testing on 100 saliva donor samples and reporting these results along with the PCR confirmation of the XPRIZE testing that was submitted less than two weeks ago to the full prize Committee. The two testing projects are going to be run against an FDA authorized, gold standard PCR test.
The company is also actively assembling the requirements for a 150 patient walk-in donor study to complete the adaptation of Genviro! for at-home use in advance of receipt of FDA guidance for at-home antigen or antigen/antibody methods. To date, the FDA has cleared only two at-home tests (including one yesterday) for detection of Covid-19, with most approvals being for at-home "collection" methods which require collected samples to be sent to a lab for assay. Additionally, of the two approved at-home tests, one still requires a doctor's prescription. Genviro! is designed to provide truly rapid, at-home testing with the ultimate goal of not requiring a prescription or any interaction with a medical professional.
Finally, DECN is immediately readying its blood testing methodology for use in animal testing for Covid-19. The company has been a recognized leader in the animal diagnostics industry with its PetSure blood glucose test strip products and Covid-19 detection is a natural extension of its work in the area. According to the CDC, research has shown that Covid-19 can infect a wide variety of animals and they can become spreaders to humans. The company plans to develop a slightly re-engineered blood testing device and similar methodology, first submitted for professional-use and at-home human use to the FDA in April and May 2020, respectively, for EUA considerations. DECN's PetSure test will be a single use all-in-one kit including test strip, interface sleeve and Swift meter.
"The company is actively involved with and undertaking a series of testing activities that will support our products across a wide spectrum of uses … from professional and point of care uses to at-home to veterinary/animal testing," said CEO Keith Berman. "The Genviro! technology is exhibiting the type of flexibility for its use and potential adoption we had hoped for. We envision multiple uses for our blood, saliva and the overall Genviro! testing methodology and will continue to pursue opportunities domestically and internationally to bring these testing capabilities to various geographic and industry markets."
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 and Puerto Rico and hopefully should soon be available in there. 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, Pennsylvania-based testing partner to complete testing per current FDA guidelines and continues to look forward to the FDA authorization of its EUAs.
The same data that is being produced by the company's Pennsylvania testing partner, will be used for submissions to the EU and Russian Federation. The company will also use PCR verified data provided by its Korean R&D and contract manufacturing partner as part of their extensive product development schedule as well as the recently reported and better than anticipated XPRIZE testing results that have been submitted for consideration as yet a third validation of the testing methodology.
The company continues to recruit and accept applications from prospective domestic and international distributors. Inquiries can be directed to: [email protected].
Forward-Looking Statements:
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of December 15, 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.
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ADDITIONAL CONTACT INFORMATION:
Decision Diagnostics Corp.
Shep Doniger 561-637-5750
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SOURCE: Decision Diagnostics Corp.