CEO asks the critical question, "Why is there such a slow march to accept Novel Covid-19 testing methodologies?"
LOS ANGELES, CA / ACCESSWIRE / July 2, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today produced an "Open Letter" outlining the need for greater and faster support for innovative solutions to the Covid-19 testing needs of the country. As a leading provider of diabetic testing kits for two decades and an early applicant for FDA EUA authorization of its testing kits to detect the Covid-19 virus, DECN has been continuing its testing efforts overseas while actively seeking FDA approval for testing protocols in the U.S. DECN's Pharma Tech Solutions subsidiary first submitted its proposed GenViro! professional use device to the FDA on April 3, 2020, almost three months ago in the middle of a pandemic.
"While the FDA has issued more than 100 EUA approvals for tests and products related to Covid-19, some of the most promising have been left on the sidelines, said Keith Berman CEO of DECN. "To be sure, we need our public health policy officials to be thorough and keep us all safe. At the same time, we need them to resist the urge to go through the motions. That means pushing the envelope, avoid taking the easier way out and stop being co-opted by, ‘the big guys.' Lives and our economy are at stake. All experts agree it is critical to identify those who are currently infected, many of whom are presumably asymptomatic, to protect those who are not and we need to act now with safety and urgency to be successful in this battle."
The entire "Open Letter" can be viewed below.
To learn more about DECN's GenViro! Swift Kit that can detect Covid-19 in approximately :10.5 seconds and to speak with CEO Keith Berman, please contact Shep Doniger at 561-637-5750 or [email protected].
AN OPEN LETTER -- Why Is There Still a Slow March to Widespread Covid-19 Testing
With more than one-half of US states now experiencing rising Covid-19 infection rates, and with infection rates rising again in multiple countries around the globe, it's clear the Novel Coronavirus remains a force to be reckoned with… and not lightly. So why is there such a slow march to equally novel Covid-19 testing methodologies?
Public health experts seem to agree on two things, the need for a vaccine and the importance of increased, immediate and affordable testing to determine exactly who is ill and contagious. As New York Governor Andrew Cuomo stated, "The more testing, the more open the economy." The President's Advisory Task Force agrees that the economy won't open completely and remain such without wide-scale testing. By wide-scale testing, The Wall Street Journal cites experts who strongly suggest numbers on the order of six million tests per week, approximately two-times what we are doing now.
But, testing is only valuable when it is accurate. In the case of a pandemic it must also be affordable and produce reliable results in minutes, even seconds. On that front there has to date been a failure to deliver. Days and weeks just won't cut it if we are to get back to anything resembling an, "old normal."
According to The New York Times, along with an inadequate number of tests, many tests are "shoddy" (with many FDA authorized test kits pulled from the market, and several, if media reports are correct, performing worse than a coin-flip), "and many do not produce definitive answers fast enough." The article referred to the FDA's quick approval of some testing as, "The Wild West" with the results too often in question. The lack of accurate test results which the public can rely on can, in many ways, be more problematic than the absence of testing itself.
Companies large and small have jumped in head first to the testing race under the FDA's guidance and with big dollars on the line. Unsurprisingly, that favors the large players to the detriment of smaller, often more nimble and innovative players. In the end, it's the public health, really all of us, who suffer. Another article points out the FDA's oversight has been inconsistent at best, stating, "The FDA must stick to its normal process for review but expedite it by giving it top priority with its clinical reviewers and bring in more reviewers if necessary."
As someone who has been deeply involved in medical technology development and research for four decades, predominantly in in-vitro diagnostics, I've seen exactly how the FDA can be easily overwhelmed and the way bureaucratic wheels grind… and it's way too slow. More so, our public health administrators favor familiar technologies whose applications often don't respond to the exact urgent needs of the moment. Worse yet, they seek familiar faces, often the big pharma-med-tech players, who like an oil tanker in the open ocean, take forever to change course in the direction required. Unfortunately for us all, this frequently unfolds at the immediate expense of creative, alternative thinking, new, unknown, smaller players who may actually have the answers, but rarely get the chance and support to appropriately test their solutions. Such participants are summarily pushed into obscurity, or worse ignored, by officials in favor of large competitors simply because its easier to stick with the status quo and go with what, and who, you know. We are witnessing this happening with the well-intentioned PPP program whose original design was to help small business but initially favored the bigger players, some of whom were quickly shamed into returning the money they had received when their receipt of these funds became public. Business simply cannot be conducted the old way when so many lives are at stake.
As the world searches for testing solutions, and we need them now, some companies such as ours who have their testing foundations in long accepted technologies that are being re-thought and re-engineered for purposes beyond their original intentions, remain seated on the bench, at least in the U.S. In overseas testing, our test kit identifies the virus in seconds, while in the U.S. we are asked to jump through regulatory "hoops" seemingly made up just for us. To be sure, we need our public health policy officials to be thorough and keep us all safe. At the same time, we need them to resist the urge to go through the motions. That means pushing the envelope, avoid taking the easier way out and stop being co-opted by, "the big guys." And to stop applying pre-conceived notions of science that apply to conventional technologies and force fit their use to new technological approaches. Lives and our economy are at stake. While not the time to overhaul the system, the system must show it can be flexible and act with safety, urgency and open-mindedness to the less-familiar that could hold the key to saving lives and getting our economy, and perhaps world economies, back on track.
(Keith Berman is CEO of Decision Diagnostics Corp. a California based manufacturer of diabetic testing technologies that have been the industry standard for decades, and whose company has submitted two applications with the FDA for a Covid-19 testing technology that identify the virus in about ten (10) seconds. The company has been in discussions with the FDA on final testing protocols since mid-April.)
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 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!™ product designed to test for Covid-19, is not yet available in the United States or Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of July 1, 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.
Decision Diagnostics Corp.
Keith Berman (805) 446-2973
SOURCE: Decision Diagnostics Corp.