Diagnostic Testing Remains Vital as New Treatment Breakthroughs are Announced

NEW YORK, Nov. 17, 2020 /PRNewswire/ -- Researchers seem to be getting closer and closer to a vaccine to properly fight the current pandemic. Yesterday, Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the Phase 3 study of mRNA-1273, its vaccine candidate against the virus, has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This is the second major announcement regarding a potential vaccine candidate this month. Just earlier last week, Pfizer and BioNTech SE announced that their vaccine candidate was found to be more than 90% effective in preventing the virus in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Nevertheless, even though researchers seem to be so close to a working vaccine, distributing it to the population in an effective manner is another obstacle to overcome. In fact, a major challenge biotech companies, hospitals and clinics across the country will need to surmount will be the massive logistical problem of keeping the vaccine doses cold. The vaccines lose effectiveness and their potency if left exposed to temperatures outside of the range they need to be kept in. Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Novavax, Inc. (NASDAQ: NVAX), FLIR Systems, Inc. (NASDAQ: FLIR), AstraZeneca Plc (NYSE: AZN).

"There's almost an assumption that once a vaccine is created and approved, then everyone is healthy and fine, but the operational component is pretty complex," said Caesar Djavaherian, an ER physician and Chief Clinical Innovation officer at Carbon Health, according to Vox. "We've never tried to administer vaccines to 100 million Americans in a short period of time." The recent struggles in the United States in properly maintaining satisfactory supply chains for tests, masks, and personal protective equipment, raises concerns that the same mistakes could be repeated in vaccine distribution effort. For example, when it comes to tests, many states and regions are experiencing a shortage of tests, which is a serious obstacle to the fight against the spread of the viral infection. Overall, testing continues to be uneven, as some states have managed to provide higher rates of testing than others. Yet, quality mass testing is necessary to ensure the strategies implemented to fight the pandemic are effective. 

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week that, "President & CEO Gerald Commissiong has provided a corporate update to the shareholders:

Dear Shareholder,

We would like to thank you for continued support as we execute on the vision we laid out in the first half of 2020, transitioning the Company from a cancer and Alzheimer's-focused R&D diagnostics company into a commercial organization focused on providing comprehensive solutions to address the United States' biggest challenges in testing, tracing and immune support in response to the COVID-19 pandemic. Going forward as the newly created business lines mature, each at their own pace, we are seeking to adjust expectations in light of the market's response to our progress and address some of the limiting factors to value creation.

Nasdaq Uplisting Timing

Given where the Company's common stock is currently trading, we do not believe it is realistic to uplist to Nasdaq in 2020, but rather look to achieve that milestone in the first half of 2021. We are focused on creating value for our common shareholders and, given where our common stock is currently trading, we believe it is prudent to remove the risk of a significant reverse split from market concerns until we have demonstrated several more months of growing sales and commercial execution. Given that the Company is now generating revenue that we expect to continue to grow significantly into 2021, we now believe that our common equity can significantly increase in value on the OTC Markets™ because we believe we are well positioned as a growing commercial organization with the upside of several attractive research & development programs with patent protected development-stage programs addressing large market opportunities. While we are disappointed the market is not currently recognizing our fundamental value, we now have a significant opportunity to begin to educate the marketplace with regards to our overall business, and specifically our COVID-19 business.

COVID-19 Testing

Todos has positioned itself as a 'one stop shop' for all things COVID testing related. We understand that there is significant confusion with regards to COVID testing, and therefore we are outlining here exactly what we offer in the different types of testing products we make available to clients:

Polymerase Chain Reaction (PCR) Testing

PCR testing is now the gold-standard in COVID-19 testing. Definitive diagnoses are almost exclusively confirmed by PCR. As such, screening and surveillance testing of any kind will ultimately lead to a confirmatory PCR test.

Equipment to create workflows capable of conducting over 20,000 PCR tests per day per lab include:

1.     RNA automated extraction machines

2.     RT-PCR machines (96 well and 384 well)

3.     Liquid handler machines

4.     Automated and semi-automated pipettes

Reagents and consumables include:

1.     Extraction reagent kits

2.     COVID and COVID + influenza a/b qPCR reagent kits

3.     Swab and Viral Transport Medium kits

4.     Robotic and manual pipette tips

5.     PCR plates

6.     Validation Samples

Todos has optimized a workflow with Tecan liquid handlers currently being implemented at our Wisconsin client that will allow their lab to reach at least 20,000 diagnostic tests per day; and with pooling strategies being deployed for screening purposes, this client is expected to reach capacity to conduct over 100,000 tests per day. This client is currently at a capacity of 3,500 diagnostic tests per day with standard processes, and therefore we are confident in their ability to scale given this added automation. As they scale, we expect our sales to scale with them and we will be working very closely with them to overcome any barriers they have to meeting their full potential.

Rapid Antigen Testing

Antigen testing allows for testing at lower accuracy rates than PCR, but with much faster turnaround times because the results are provided at the point of care. As such, it screens more people faster and take immediate action if a positive test leads to a suspected case of COVID-19 that needs to be confirmed by PCR. The Company has entered into several agreements with companies focused on bringing antigen tests into the marketplace. While our sales have been focused on PCR testing, we believe rapid antigen testing will become routine in the United States in the months ahead as new tests enter the marketplace and bring prices down to a level where tests can be deployed in virtually any setting. We have entered into one agreement in particular with a US-based manufacturer that expects to receive Emergency Use Authorization for their test in the near future, and we have significant plans to allow our sub-distribution network to aggressively market this test upon approval.

Rapid Antibody Testing

As schools, employers and other constituents begin to implement comprehensive COVID-19 surveillance programs, one of the key questions emerging is whether individuals have previously been infected with COVID-19. We have secured rights to the FDA Emergency Use Authorization (EUA) FaStep rapid SARS-CoV-2 antibody test and have added this to our offering to our sub-distribution partners.

Emerging COVID-19 Testing Technologies

The Company has also secured rights to several tests that are currently awaiting EUA approval from the FDA. These tests include point-of-care PCR tests that will compete with the Abbott ID Now™ and Cepheid point of care molecular tests. We also expect to enter into an agreement to secure distribution rights to lab-based tests to more comprehensively evaluate COVID-19 immune-status that we believe will become paramount as vaccines enter the marketplace and testing for immunity becomes more widespread in 2021…"

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Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced last week their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. "Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19," said Dr. Albert Bourla, Pfizer Chairman and CEO. "We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks."

Novavax, Inc. (NASDAQ: NVAX) announced on September 15th, an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX–CoV2373, Novavax' COVID–19 vaccine candidate. With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVX–CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix–M™ adjuvant.  "Today's agreement with Serum Institute enhances Novavax' commitment to equitable global delivery of our COVID-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks."

FLIR Systems, Inc. (NASDAQ: FLIR) announced earlier in June the FLIR Screen-ESTTM software for FLIR T-Series, Exx-Series, and A-Series thermal imaging cameras. The software provides automatic measurement tools that perform elevated skin temperature screenings of individuals in two seconds or less at entries, checkpoints, and other high-traffic areas while maintaining recommended social distancing guidelines. "Governments and businesses across the globe are hard at work developing new processes to ensure public health and safety from COVID-19, including the use of radiometric thermal imaging cameras as part of a comprehensive frontline screening program," said Jim Cannon, President and CEO at FLIR. "Now with FLIR Screen-EST software, those organizations can increase the speed and accuracy of frontline screening when using FLIR's thermal cameras."

AstraZeneca Plc (NYSE: AZN) concluded on August 14th, an agreement with the European Commission (EC) to supply up to 400 million doses of the AZD1222 COVID-19 vaccine. Building on the existing agreement with Europe's Inclusive Vaccines Alliance spearheaded by Germany, France, Italy and the Netherlands, this new agreement will give all EU member states the option to access the vaccine in an equitable manner at no profit during the pandemic. It also allows EU member states to redirect doses to other European countries.  Pascal Soriot, Chief Executive Officer, said: "This first vaccine agreement with the European Commission will ensure that millions of Europeans have access to the AZD1222 vaccine following its approval. With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020. I would like to thank the entire European Commission, and especially the Commissioner for Health and Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may soon be protected with a vaccine against this deadly virus, enabling our global society and economy to rebuild."

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