FDA Commissioner Dr. Stephen Hahn says, “These types of tests will be a game changer”
LOS ANGELES, CA / ACCESSWIRE / August 3, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, through its subsidiary Pharma Tech Solutions, Inc., today announced its support for the recently issued FDA Covid-19 At-Home Use Template saying it, “Contains much of what was in our May 1st At-Home Application to the FDA.” The company says it is 100 percent behind the issuance of at-home testing guidelines, and that it is now preparing to amend its first EUA submission PEUA200947, for its GenViro! Blood Swift Kit for at-home use. Shortly thereafter we anticipate filing a separate EUA application with the FDA for its GenViro! Saliva Swift Kit for home use. Both applications for the home use of GenViro! Swift are expected to meet the new FDA template, the FDA’s first such template issued by the FDA. No Covid-19 home-based test kits have as yet been authorized by the FDA, although several at-home specimen collection kits have been authorized. Nonetheless, experts universally agree that routine at-home testing of people who may be asymptomatic can be transformative in the effort to significantly slow the spread. Current at-home specimen collection kits do not provide at-home point of care testing.
“As we have repeatedly stated, the FDA has moved the goalposts on a variety of testing and use matters so we welcome their settling on these first at-home testing guidelines, especially since our previously filed application appears to have correctly anticipated a lot of what they would eventually require,” said DECN CEO Keith Berman. “We have always concurred with Commissioner Hahn that convenient and affordable at-home testing will be a game changer, providing the potential for screening on a daily basis if desired. All versions of our GenViro! Swift test kits are true point of care devices, whether the point of care is in the home, at the office, or are administered by a professional. This allows for screening for the virus on site, anywhere, anytime and will help people get back to work, or attend school, board an airplane, go to a social event, attend a house of worship, and visit loved ones, including those with assisted living arrangements, all as restrictions are lifted, with a much greater sense of security.”
While the company supports the issuance of this template, it agrees with some experts that they could also be less stringent, for example the reporting requirement the FDA has built into the template. Dr. Michael Mina an infectious disease epidemiologist at Harvard’s T.H. Chan School of Public Health believes the FDA standards are important but may yet be too high. “Standards should be lowered further… [with the way] the FDA’s guidance is written it makes it less likely that such crucial tests will reach the general public.”
DECN is currently preparing for U.S. based testing of its COVID-19 test kits. The company just received completed testing from its Korean partner where the required 75 non-infected donors were tested for both blood and saliva (a total of 150). The next step for our partner will be to test known infected samples. These tests will be done in conjunction with a Korean teaching hospital or similar institution. Once completed, this testing data will provide the filing data needed for the anticipated EU CE Mark and registration of our GenViro! Swift kits in other off-shore countries as may be required.
In addition, the company has ordered approximately 600 Genviro! Swift testing strips delivered to us in vials for the feasibility rounds of testing in the USA. The company has received the first 300 of these sensors and plans to begin testing for saliva based samples with its chosen U.S. based partner. After this initial USA testing, another 600 test strips for the second, more demanding study will be conducted by the company’s clinical testing partner in the U.S. 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, www.pharmatechdirect.com, to demonstrate in more detail the contents of the GenViro! Swift Kits.
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!™ Swift kit products are designed to test for Covid-19, and applications for Emergency (EUA) Waivers have been submitted to the U.S. FDA. Additional applications are anticipated. Our new GenViro! Swift kit for saliva testing as well as our finger stick test kit are 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 30, 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.
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