More Comprehensive Diagnostics are Needed as Cases Surge Once More

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Nov 13, 2020, 09:00 ET

NEW YORK, Nov. 13, 2020 /PRNewswire/ -- The pandemic is in full swing once again; the daily U.S. death toll crossed the 2,000 mark on Wednesday as weeks of rising infection rates are now manifesting in mortality numbers not seen since May. In addition, the mayor of Chicago has issued a new Stay-at-Home advisory. As part of the advisory, Chicagoans are asked to only leave the house for work or school or essential needs, which include getting medical care, going to the grocery store or pharmacy, getting takeout food or to receive deliveries. And as the United States surpasses a record for new infections and hospitalizations, one of President-elect Joe Biden's advisers has suggested a nationwide lockdown. According to a report by ABC, the U.S. has recorded over 240,000 deaths and more than 10.3 million confirmed infections to date. Dr. Michael Osterholm, a pandemic adviser to Biden, said the drastic move could help bring the pandemic under control in the United States and even revive the economy. Todos Medical Ltd. (OTCQB: TOMDF), Amarin Corporation plc (NASDAQ: AMRN), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Co-Diagnostics, Inc. (NASDAQ: CODX), Altimmune, Inc. (NASDAQ: ALT)

To properly fight the continued spread of the virus, testing on a mass scale is crucial. For example, on Tuesday morning at a news conference in front of UC San Diego's Geisel library, district board member Richard Barrera laid out the critical importance of being able to do just that. According to KPBS, Barrera explained that, "the ability to regularly test our students and our employees who are coming onto campus is such an important factor in our ability to open and stay open." Overall, testing continues to be uneven, as some states have managed to provide higher rates of testing than others. In the meantime, various companies are racing to develop antibody tests, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus.

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news yesterday regarding, "revenues for the month of October of $867,000, representing a 147% month over month increase in sales. The revenues were primarily made up of extraction reagents sales. Current weekly orders for our extraction reagents have increased to over 40,000 units per week for our legacy clients. The Company is currently assisting its 5 largest contracted clients to complete qPCR kits validations and expects revenues from those qPCR kit sales to begin towards the end of November 2020, at which point the Company's clients will have capacity to run over 350,000 tests per week.

'The month of October was critical for Todos as we continued to build the infrastructure needed to support sales growth in our extraction reagents business, and began preparations for the addition of qPCR kits as a major revenue driver heading into the winter months,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'We have made considerable investments to help our clients automate various lab processes to improve efficiency, capacity and quality control for COVID testing. We have identified suppliers and have now sourced large quantities of vital accessories, such as manual and robotic pipette tips and qPCR plates, that are in extremely short supply in the lab services market as testing increases worldwide. With this access to the key workflow items needed to scale our clients now firmly established, we are assisting our lab clients reach larger testing capacities just as we are seeing a record spike of COVID-19 cases in the United States.'

Mr. Commissiong continued, 'Todos submitted an emergency use authorization request for its Todos-branded qPCR kits in September 2020. Several of our clients are beginning to validate our COVID qPCR assay, as well as our COVID + influenza a/b qPCR assay as demand begins to grow for this innovative product heading into flu season. We believe that the addition of influenza a/b will differentiate our qPCR kits from others in the market, and that several new labs will begin using Todos' qPCR kits given its high quality and the related ready access to all the consumables and equipment needed to meet their demand. We have also begun sales, through sub-distribution partners, of rapid antigen and rapid antibody tests in the United States that we expect will be a major driver of point of care testing that is set to explode in the months ahead. We support this type of surveillance testing, largely because asymptomatic COVID cases identified by antigen testing must be confirmed by PCR, which is likely to increase PCR testing demand as many more people become used to weekly testing regimes. We believe that the combination of rapid point of care tests combined with lab-based PCR testing will become the bedrock of the United States testing paradigm as we head into 2021. Further, we are making progress in bringing on new testing technologies that will allow for monitoring of immune responses from active COVID cases, as well as newly vaccinated individuals as vaccines begin to enter the market later this year.'

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com"

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Amarin Corporation plc (NASDAQ:AMRN) announced on August 7th, support for an investigator-initiated trial to study the effects of icosapent ethyl (VASCEPA®) (IPE) on laboratory-confirmed viral upper respiratory infection (URI) rates, clinical impact and outcomes, especially with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection which causes COVID-19, in adults with established atherosclerotic cardiovascular disease (ASCVD) who are at elevated risk of experiencing moderate to severe COVID-19.1,2 "Most prior clinical trials for COVID-19 have focused on treating patients hospitalized for moderate or severe COVID-19 with experimental agents," according to Dr. Ambrosy. "MITIGATE COVID-19 is novel in that we will study the effects of pre-treatment with IPE, an FDA-approved therapy for primary and secondary prevention with putative anti-inflammatory as well as antiviral properties, in high-risk outpatients with ASCVD on subsequent risk of viral URI-related morbidity and mortality."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced on July 30th that its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates (NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination. These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination. Dr. J. Joseph Kim, President and Chief Executive Officer of INOVIO, said, "All other previously reported NHP vaccine protection studies actually challenged the animals at the peak of their immune response. Our study demonstrates that INO-4800 could provide protection in a more real-world setting, where vaccine-generated memory immune responses protected NHPs for more than 3 months (13 weeks) from the last vaccination. Given the importance of protective antibody and T cell responses, this study gives us more confidence as we continue to advance INO-4800 in the clinic. We believe INO-4800 holds significant potential to help address this global public health crisis."

Co-Diagnostics, Inc. (NASDAQ: CODX) announced on October 2nd that Access Genetics, LLC dba OralDNA® Labs, a CLIA-certified customer who uses the Company's Logix Smart™ COVID-19 kit in their FDA authorized OraRisk® COVID-19 RT-PCR test, recently received an amended Emergency Use Authorization (EUA) allowing testing from a saline oral rinse collection. Dwight Egan, CEO of Co-Diagnostics, remarked "We are pleased that Co-Diagnostics technology is being used in the first FDA EUA for a test using a simple saline 30 second swish and gargle collection. Because it eliminates the need for a nasal swab, oral rinse technology has the potential to dramatically improve comfort and accessibility of testing in our communities and we believe this authorization by the FDA provides additional confirmation of the quality, versatility, and adaptability of our CoPrimer™ platform."

Altimmune, Inc. (NASDAQ: ALT) announced on November 10th, that it entered into an agreement with Lonza for the manufacturing of AdCOVID™, Altimmune's next-generation, single-dose intranasal vaccine candidate for COVID-19. Lonza is a leading global biopharmaceutical manufacturing company with facilities in Europe, North America, and South Asia. "We are excited about the potential of our AdCOVID vaccine candidate and are actively focused on expanding our network of strategic manufacturing partners to ensure Altimmune's commercial readiness to supply vaccine in 2021 should our clinical data support this advancement," said Dr. Vyjoo Krishnan, Ph.D., Vice President of Product Development for Altimmune. "Lonza is a tremendous partner in this mission, with deep expertise and experience in vector manufacturing and global world class facilities capable of manufacturing AdCOVID at commercial scale."

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