Company to Receive Production Sample Kits from its Contract Manufacturer for U.S. FDA Level Testing of Each Modality, Plus Additional Sample GenViro! Swift Kits for International Testing Needs
LOS ANGELES, CA / ACCESSWIRE / July 23, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today announced it is immediately readying testing samples of its GenViro! Covid-19 Swift Kits for testing in the US market and additional testing internationally. One-half will be used in a blood-based testing protocol and the other half in a saliva-based testing protocol. Based on the results, the company will make a direct run for completion of the feasibility testing so that sales of GenViro! Swift kits can commence as soon as possible in select International markets in which the company has or shortly expects to have distribution agreements. The company is conducting a parallel “sister” study in Korea, and additional saliva testing will be completed for international distribution.
DECN expects to receive the U.S. supply of production testing samples during the first week of August 2020 which is expected to coincide with the company’s selection of an experienced US based clinical testing partner. The company has narrowed potential US testing partners to two clinical trials organizations and allied laboratories and expects to announce its decision in the next few days. That organization will lead the clinical trials in the U.S. that DECN expects will be the final requirement to secure FDA emergency authorization.
The company plans a total of four studies, two covering feasibility for both the blood based and saliva based modalities, using as a foundation the most recent FDA guidelines for both blood and saliva-based testing, and two each covering the actual clinical testing. Once the feasibility testing is completed, the company will make any final adjustments that may be required to impedance wavelength. And through its European distributor(s) the company will be seeking European CE Mark certification. The CE registration is primarily a Good Manufacturing Practices (GMP) review, which is not as protracted as the FDA testing. Further, to register GenViro! Swift for CE Mark, DECN’s feasibility testing will similarly meet the product registration needs of the recently announced Asian distributor. The company has also had involved discussions with a California organization with worldwide reach. This organization is already an approved FDA establishment provider, and has expressed significant interest in a distribution relationship in the EU, Pakistan and select Middle Eastern countries.
Important to the continued movement toward FDA testing, the company is in the final stages of producing two Point-of-Care instructional videos that will be available on the web site of the company’s subsidiary, Pharma Tech Solutions. These videos are also a part of the FDA EUA (emergency) application process. DECN will furnish subtitles for the videos and will initially be made available in French, German, Spanish and Portuguese. Later versions are contemplated in additional languages.
“Although we have just passed the 120 day mark in the journey to get to this point, we are confident we are ready to conduct the revised FDA level testing required to gain emergency authorization approval here in the US,” said Keith Berman, DECN CEO. “While we have dealt with four separate FDA foundation adjustments since we first began development of our GenViro! Covid-19 Swift Kit products, late last week we learned we aren’t the only small company with proprietary technology that is dealing with such issues. ”
The company has ordered approximately 600 Genviro! Swift testing strips delivered in vials for the feasibility rounds of testing; 300 for testing in both Korea and the U.S. After this initial testing, another 600 test strips for the second, more demanding study to be conducted by the clinical testing partner in the US. Delivery of the second round of test strips is expected the 3rd week in August. In all, a total of 1,200 testing sensors plus 90 complete GenViro! Test kits will be delivered, 30 available for blood and 30 available for saliva, and another 30 saliva kits available for demonstration and photographic purposes overseas. The company will be updating its Pharma Tech Solutions web site to demonstrate in more detail the contents of the GenViro! Swift test kits.
Mr. Berman concluded, “Finally, it is important that we recognize that the new FDA testing mandates places a huge strain on company resources. Testing is expensive enough, but the testing of infected subjects requires special insurance policies where the premiums are extreme. A bill to be shortly presented in the U.S. Senate seeks to lower liability limits for companies and first responders, and if passed will be among the biggest adjuncts to our expected success.”
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. has been the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters for 18 years. 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. The company’s GenViro!™ products are designed to test for Covid-19, and applications for Emergency (EUA) Waivers have been submitted to the U.S. FDA. The finger stick test kit is currently being readied for international sales and an agreement for distribution has been signed for sales to commence in multiple countries including India, Malaysia, Singapore, Nepal, Bangladesh, Sri Lanka, Indonesia, Thailand, Vietnam and Australia. Registration in those countries where such documentation is required is the responsibility of the distributor.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of July 22, 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.
SOURCE: Decision Diagnostics Corp.