Demand for Effective Diagnostics Surges Alongside a New Wave

NEW YORK, Oct. 27, 2020 /PRNewswire/ -- The pandemic is accelerating once again. According to recent reports, cases are continuing to surge across the United States with at least 37 states seeing a rise in hospitalizations. More than 8.6 million Americans have now been infected with the virus and the number of deaths has surpassed 225,000. In fact, the average number of new daily cases in the United States is at a record, which in turn puts pressure on local hospital systems, forcing new curfews and other restrictions in various parts across the country. The U.S. is also testing more people than ever, but according to data compiled by the Covid Tracking Project, more testing cannot be an explanation for the rise in cases because the percent of tests coming back positive has increased as well, Health officials explained. Todos Medical Ltd. (OTC: TOMDF), Novavax, Inc. (NASDAQ: NVAX), ADMA Biologics, Inc. (NASDAQ: ADMA), Cerus Corporation (NASDAQ: CERS), BioNTech SE (NASDAQ: BNTX)

The high demand for tests has put the diagnostics test manufacturing industry under immense pressure. The sudden global need for accurate, high-quality testing is unlike anything it has experienced before. According to a report by Barron's, "To meet growing global demand, current test manufacturers and their supply chains need to continue investing to scale up production. That alone won't be enough. More companies need to start manufacturing tests. In the U.S. only a few companies have been granted FDA Emergency Use Authorization to sell rapid diagnostic tests, and most of these tests are manufactured offshore. Transferring the manufacturing technology for these high-quality tests to the U.S. and building up local manufacturing facilities would quickly increase the supply."

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news regarding, "the completion of the instrument validation in its mobile lab division. The Company's mobile CLIA lab partner, Integrated Health, has fully validated the analytical performance of the Company's proprietary ANDis 350 RNA auto-extraction machine in combination with its Accurate 96 qPCR machine as part of the COVID-19 RT-PCR laboratory testing validation process being performed in MOTO+PARA's Mobile High Complexity Lab. Integrated Health expects to complete the clinical validation needed to support the commercial launch in mid-November. MOTO+PARA is in talks with several entities and expects to begin accepting contracts in mid-November 2020.

'We have spent the last 3 months building the mobile labs system in preparation for a commercial launch with a focus on the highest quality, consistent data generation, and overcoming the many technical challenges that presented themselves in the creation of a highly scalable Biosafety Level 3 built mobile lab,' said Eric Canonico, CEO of MOTOPARA Foundation. 'We are pleased to have these high levels of analytical performance in the Todos instruments.'

'We feel extremely comfortable working with these instruments given the quality and consistency of the data we can now generate after spending the last 8 weeks in validation,' said Brandon Albin, Managing Partner at Integrated Health. 'We are confident we can commercially launch the COVID-19 qPCR assay using Todos' testing paradigm and reach capacity of 1000 PCR tests per day per mobile unit, in addition to antigen and antibody testing.'

'We are very excited about the potential of the mobile labs project to increase the availability and quality of testing in the United States and abroad,' said Gerald Commissiong, President & CEO of Todos Medical. "Having the ability to reduce PCR turnaround times from 3-6 days to potentially as little as 3-6 hours is a complete game changer in terms of speed to diagnosis and reducing time to isolation, which would dramatically reduce the potential for a patient to become a close contact to others, as defined by the Centers for Disease Control. We will also be offering COVID-19 antigen screening and surveillance testing, as well as antibody testing to our laboratory and delivery of care partners.

Currently, Integrated Health is in the process of testing 30 known positive and 30 known negative samples to receive CLIA certification allowing MOTO+PARA High Complexity Mobile Labs to operate under Integrated Health's U.S. national mobile CLIA lab license, authorized in all 50 states in the U.S. The companies expect to reach this milestone in mid-November.

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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."

ADMA Biologics, Inc. (NASDAQ: ADMA) announced earlier last month the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank™ was developed in collaboration with Leinco Technologies, Inc. ImmunoRank is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes. ImmunoRank is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes. An Emergency Use Authorization (EUA) submission is currently being prepared for review and potential approval by the U.S. Food and Drug Administration. We will report on material regulatory and commercial developments as we progress.  ADMA has submitted patents for ImmunoRank in the U.S. and certain foreign markets. Both ADMA and Leinco are named as co-inventors on the patents.

Cerus Corporation (NASDAQ: CERS) reported back in July study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion. These data are consistent with prior INTERCEPT studies showing complete inactivation, to below the limit of detection, of other coronaviruses associated with severe pulmonary disease: MERS-CoV1,2 (2018, 2019) and SARS-CoV-1 (2005). The in vitro study evaluated inactivation of SARS-CoV-2 in plasma components using both infection and molecular assays, as well as cell culture passaging experiments, allowing the confirmation of complete inactivation over time. Under the Principal Investigators Prof. Esam Ibraheem Azhar (Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia) and Prof. Salwa Hindawi (Department of Hematology, Faculty of Medicine), the study was conducted at the Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia, with a local clinical SARS-CoV-2 isolate. This center is known for its expertise in coronavirus research. A manuscript for publication is currently in preparation. The investigators are currently conducting a subsequent study to assess the ability of the INTERCEPT Blood System to inactivate SARS-CoV-2 in platelet components. These studies are funded by the Saudi Arabia Ministry of Health and supported by Cerus.

BioNTech SE (NASDAQ: BNTX) announced on September 17th, the signing of a share purchase agreement with Novartis AG, Basel / Switzerland to acquire their GMP certified manufacturing facility in Marburg, Germany. The manufacturing site will expand BioNTech's COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. The transaction is expected to close in the fourth quarter of 2020. The Company plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021, thanks to the established team and well-established drug substance and drug product manufacturing capabilities at the site.  "This acquisition reflects BioNTech's commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval. We are working closely with Novartis to prepare for a smooth transition, and we look forward to welcoming the new members of our team and tapping into their impressive skills and expertise. From a strategic standpoint, the new site will bolster our vertically integrated business model with in-house manufacturing capabilities for mRNA manufacturing as well as vaccine formulation," said Dr. Sierk Poetting, Chief Financial Officer and Chief Operating Officer at BioNTech.

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