DECN CEO Releases Open Letter on FDA At-Home COVID-19 Rapid Testing Guidelines Saying It’s the Speed to Results Reporting and Certain Added Regulations That Need to Be Addressed
CEO asks the critical questions, “We hear every day about new “rapid” tests, both in the press and from government officials, so I ask what is meant by the term “rapid,” and moreover, how does a manufacturer or distributor deal with the new FDA at-home reporting requisites which counter the most long-awaited benefits of an at-home test – its anonymity”
LOS ANGELES, CA / ACCESSWIRE / August 10, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, through its subsidiary Pharma Tech Solutions, Inc., today has released an “Open Letter” in support of the FDA’s recent announcement of at-home rapid testing guidelines. DECN, in its Open Letter states that it’s likely that debate will intensify over the definition of what a “rapid” kit is, as well as the new layer of regulatory requirements the FDA plans to add to at-home use products which for the first time includes regulations applicable to users of the kits, for such things as reporting to Federal agencies. DECN views these new regulatory layers as huge impediments to the future adoption of the Covid-19 at-home tests in the hands of the general public.
According to DECN CEO Keith Berman, “While the actual testing requirements can be debated in terms of being too stringent and needing realignment, the fact is that we need to clearly define the meaning of “rapid” when we refer to Covid-19 testing, and then address the “hidden” regulatory requirements that could significantly slow and inhibit such testing. The current reporting required by the FDA guidelines and red tape requirements are a serious impediment and present significant sticking points to getting a truly rapid at-home point-of-care test in the public’s hands anytime soon.”
For example, the FDA has only released at-home testing guidelines for molecular self-testing and not for serological or direct antigen based tests. As a leading provider of diabetic testing kits for two decades and an early applicant for FDA EUA authorization of its testing kits, the company’s testing overseas is showing that both Covid-19 Swift Kits, for blood and saliva, complete their assays in 10.5 seconds or less, proving that true “rapid” testing is achievable. And, because our testing is based on our diabetes testing model using a meter and strip, just as important is its scalability, a key ingredient necessary to meet the nation’s testing needs. DECN has been continuing its testing efforts overseas. The company’s Pharma Tech Solutions subsidiary first submitted its proposed GenViro! professional use device application to the FDA on April 3, 2020 and its at-home Genviro! Device application on May 1, 2020.
“The FDA has issued more than 170 EUA approvals for molecular (PCR) based tests and very few for rapid antigen (non-PCR) testing which we believe is what will help get the nation back to work and something resembling a more normal life,” Berman said. “The first issue to be dealt with is the notion of a test being “rapid.” This terminology should not be attached to a test kit that takes 2 to 4 days (or longer) for results to be delivered back to the patient, a test method that requires expensive testing machines to produce results and that will require the at-home user to pay a few hundred dollars per test like the authorized professional kits cost. Long reporting times and expensive tests do not help the overall situation.”
He continued, “Nobody is suggesting that our public health policy officials should be anything but thorough to keep us safe. However, the current testing regimen has technology and institutional drawbacks that have 2, 4 or 7 day waits for results, rendering such tests much less effective. This delay also effectively eliminates any possible tracing of an asymptomatic person who in fact tests positive as well as those “superspreaders.” Such a delay can only lead to further spread of the virus. The DECN Swift Kits, both blood and saliva, are designed to achieve results in 10.5 seconds or less. That’s what rapid means. “
The FDA needs to act quicker. That means reducing burdensome sensitivity requirements as has been suggested by many well-respected experts and instead focusing more on time to result reporting (speed) and costs. It also means considering the elimination of wasteful, time consuming and unproductive regulations in order to cut through the red tape. Guidelines should be constructed to include testing that can actually be accomplished by lay, at-home users. Our elected officials took such actions on behalf of all Americans when their willingness to safely relax burdensome regulations helped deliver a record economy and employment.
If we are to get this virus under control, it’s going to take that same level of resolve and flexibility to deliver rapid testing results. As reported in the New York Times on August 7, 2020, “Experts are revising their views on the best methods to detect infections, setting aside long-held standards so that the spread of the virus can be more quickly tracked and contained […] The best chance to rein in the sprawling outbreaks in the United States now, experts say, requires widespread adoption of less accurate tests, as long as they’re administered quickly and often enough.” We firmly believe that GenViro! Swift kits will help alleviate the need to adopt less accurate tests while still reporting Covid-19 test results in an anticipated 10.5 seconds. Some have even suggested we need a “Manhattan Project” approach to attacking this virus. We cannot afford to let such regulations get in our way. Lives and our economy are at stake.
The entire “Open Letter” can be viewed below.
To learn more about DECN’s GenViro! Swift Kits that can detect Covid-19 in approximately :10.5 seconds or less and to speak with CEO Keith Berman, please contact Shep Doniger at 561-637-5750 or sdoniger@bdcginc.com.
AN OPEN LETTER – What Exactly is a “Rapid” Covid-19 Test and the “Hidden” Regulatory Challenges Behind the FDA’s Rapid At-Home Covid-19 Testing Guidelines
With a huge focus on the steps we must take to find a vaccine and hopefully a cure for Covid-19, almost as important is what is considered “rapid” testing and exactly what regulatory requirements will accompany every test, therapy and eventually a vaccine. As we await a vaccine that we all certainly hope will come, we must focus on developing rapid, regular and scalable testing and that will remain a requirement until we have a solution.
As I have stated in a previous Open Letter, public health experts all agree on two things: the need for a vaccine and the importance of increased, rapid and affordable testing to determine exactly who is ill and contagious. For America to get back to work, to school, to family visits and enjoying time safely with friends and an overall way of life that bears a meaningful relationship to where we were seven or so months ago, we will need rapid, wide-scale, at-home, affordable, scalable, reliable and repeatable testing. We need the ability, like millions of diabetics who monitor and test their glucose levels multiple times do daily, to use methodologies that become commonplace and can be weaved conveniently, efficiently and reliably into our daily lives at least for the foreseeable future.
Companies will continue to work to meet the testing guidelines set by the FDA as they are the obvious first hurdle to producing the testing solutions that are needed. We must urgently examine whether these are indeed necessary to the degree they’ve been issued. Beyond that, hiding behind the top line requirements is an odd definition of what’s considered “rapid” as well as a series of difficult to meet lesser requirements that could potentially derail even the best of tests. For example, while the FDA has recently put out base level requirements to cover at-home Covid-19 testing, they have also added a huge burden into the process by mandating a reporting mechanism that will depress the overall demand for such testing by requiring reporting each test to and through governmental agencies. If millions of lay, at-home users decide to avail themselves of a Covid-19 test, the FDA is going to need to explain which government agency is capable of receiving and monitoring data from millions of those who test, and then they will have to implement it.
One of the major benefits of at-home testing is the anonymity people seek. The usual alternative to patient self-reporting is a doctor’s prescription where both the doctor and the retail establishment report to the government and private insurers, but these alternatives are flawed as well. Physicians’ offices are not structured or staffed to prescribe and then re-prescribe multiple instances of at-home testing determined by the patient, for example 2-3 times a week for a large percentage of their patients, until the pandemic is under control. And, those seeking the tests will frequently desire anonymity and many might forego self-testing altogether if anonymity cannot be assured. This same dilemma existed in the diabetic self-testing market for two decades until the demand for doctors’ orders and the demand to treat diabetic test strips and supplies as if they were pharmaceuticals waned. And, there was never a requirement for self-reporting to government agencies by diabetics in the first place.
Another regulatory impediment is that the new FDA guidelines are so far only published for molecular (PCR) at-home testing. We cannot think of a testing method less appropriate for at-home testing. Analyzers that read and determine these types of tests range in price from several hundred to over $40,000. These analyzers are not reimbursed to individuals by federal programs like Medicare, Medicaid or private insurers. Which at-home user has a spare $40,000 to spend on an analyzer. On top of that, who is going to manufacture these machines in quantities in the millions? There is just no understanding of reality here.
In addition, the reporting time issue again becomes part of the testing equation. Molecular tests have been around for over three decades. While they work well, albeit slowly, they are not designed for point-of-care use. So why I ask, did the FDA go to the trouble of writing regulation in great detail, and so late in the pandemic, about a type of test that creates more questions than it answers?
Finally, there is the issue of the FDA request for Flex tests and a pretty extensive donor study for an at-home kit to be approved. We, for example, cannot envision what valued information could be gathered from patients in a blind study, particularly since the test accuracy information will have already been completed. This is not how the FDA’s own EUA authorization process is supposed to operate – and they wrote and amended the original EUA expectations as well as these new ones. The validation of whether the Rapid (or not so rapid) Kit actually works will already have been determined during the first round of clinical testing – the so-called 30/75 testing.
In our May 1st, 2020 at-home testing EUA application we envisioned a smaller donor study – one with laser focused goals, to determine if the individual donors, with assistance from an instructional test kit insert and a companion testing video could, without the assistance of a professional, quickly acquaint themselves and then accomplish the self-testing. Instead of simply business as usual, the FDA should do everything to embrace innovation at this critical moment in time, not stifle it, and not provide guidance for a methodology that won’t accomplish the necessary goals required for a successful at-home test. Shouldn’t one of the overriding goals of an at-home testing regimen be that lay people actually want to use the test kits?
We must be honest about what’s considered “rapid.” Molecular testing that takes days to produce results, that require expensive testing machinery on site to produce a not so “rapid” result and that could cost at-home users hundreds of dollars per test are neither “rapid” nor effective. The country needs instant results that are affordable and flexible in terms of the ease required to conduct them and the ability to test anytime, anywhere.
Testing remains only as good as the requirements that govern it and if we cannot meet those often unreasonable requirements that thwart progress, crush innovation and do not add to safety and accuracy, many promising testing technologies won’t see the light of day. If that’s to be the case, we all lose. Many of our leaders have seen fit to safely and effectively relax regulations in the name of getting the economy back on track. As it concerns testing for the virus, this country desperately needs to adopt the same ability to sift through what’s needed and what’s not to keep us safe, yet find the solutions we need to get 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 ten (10) seconds or less. 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.
Forward-Looking Statements:
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of August 7, 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.
Keith Berman (805) 446-2973
info@decisiondiagnostics.co
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.
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