The Evolution of Diagnostic Capabilities Underscores the Fight Against Viral Infections

NEW YORK, Oct. 8, 2020 /PRNewswire/ -- Diagnostic tests are usually conducted in laboratories, private or public, which are equipped with appropriate and sometimes expensive instrumentation and staffed with trained and qualified personnel to perform the tests. There are also various types of diagnostic methods including In Vitro Diagnostics (IVD), Point of Care (POC), Molecular diagnostics, genomic diagnostics and others. During a pandemic, many states and regions are experiencing a shortage of tests, which is a serious obstacle in the fight against the spread of the viral infections. Overall, testing continues to be uneven, as some states have managed to provide higher rates of testing than others. Nevertheless, 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. (OTC: TOMDF), ADMA Biologics, Inc. (NASDAQ: ADMA), Cerus Corporation (NASDAQ: CERS), CytoDyn Inc. (OTC: CYDY), Moderna, Inc. (NASDAQ: MRNA).

The National Institutes of Health (NIH), working in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), announced earlier this week a third round of contract awards for scale-up and manufacturing of new testing technologies for the current pandemic. The six new Rapid Acceleration of Diagnostics (RADx) initiative contracts total USD 98.35 Million for point-of-care and other novel test approaches that provide new modes of sample collection, processing and return of results. "Since launching in April, the NIH RADx initiative has moved swiftly to facilitate critical expansion of early and late-stage testing technologies as well as research to remove barriers to testing for underserved and vulnerable populations," said NIH Director Francis S. Collins, M.D., Ph.D. "Each of the technologies emerging from the RADx initiative will play a critical role in extending accessibility to testing in diverse settings."

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news yesterday that it has, "entered into an exclusive supply agreement with U.S. national mobile CLIA laboratory company Integrated Health LLC operating MOTOPARA Foundation's mobile biosafety level 3-built laboratories (the "Mobile Labs") developed to address the global COVID-19 pandemic. The Mobile Labs are initially capable of running 1,000 PCR tests per 8-hour shift and can scale to 3,000 PCR tests per 8-hour shift upon proper process implementation, and capable of processing Rapid Antigen Tests and Rapid Antibody Tests as screening tools as part of overall testing protocols designed to improve testing capacity and reduce positivity rates. MOTO+PARA expects to be able to scale production by end of Q4 2020.

'We have been working with Todos Medical for several months and believe they've put together the most comprehensive set of testing solutions that our organization needs to effectively execute our Mobile Labs strategy,' said Eric Canonico, CEO of MOTOPARA Foundation. 'We are preparing to meet the significant need for mobile testing solutions nationwide so that we can open American communities safely. Integrated Health has been tremendously innovative and has provided us with a compliant U.S. national mobile CLIA laboratory certificate to accomplish testing in our BSL-3 built environment, which gives us the latitude necessary to follow the science as testing for COVID-19 evolves in the months ahead. Our solution sets us apart from other mobile testing protocols because we provide a closed-loop solution that establishes a secured chain-of custody from collection to results for rapid COVID-19 testing onsite at scale as well as tests for other respiratory illnesses. This Mobile Labs network will add a key tool in our battle with COVID-19 heading into the fall and winter months.'

MOTOPARA Foundation is a non-profit organization managing well-trained retired service veterans from all branches of the military encompassing site operations, physicians, paramedics, and nurses in coordination to provide disaster relief solutions. MOTO+PARA has designed its Mobile Testing and Lab Solution to provide comprehensive services for large scale screening and surveillance, diagnostic triage and confirmatory PCR testing to provide a complete risk assessment that supplies better information to decision makers for threat assessment and possible courses of action. Integrated Health is guiding the first Mobile Lab through CLIA laboratory validation, providing leadership and direction for laboratory policy and practice adherence. MOTO+PARA owns and operates the Mobile Labs, vehicles, vessels, and aircraft, as well as technical staff, healthcare staff and logistics personnel required to administer secured testing and laboratory services.

'Working with MOTO+PARA and Todos is a great opportunity to deploy our mobile CLIA lab capabilities,' said Jeff Facheaux, CEO at Integrated Health. 'We are fortunate to already have been well positioned in the mobile CLIA lab application and are excited to be validating and preparing to scale our Mobile Labs methods, processes and procedures for the units that will begin deployment starting in October.'

'We are very excited to have helped build the first two Mobile Labs, with the first one currently undergoing CLIA validation, and we are very excited to help build many more as MOTO+PARA is able to secure fully-funded contracts for their deployment,' said Gerald Commissiong, President & CEO of Todos Medical. 'As we forecast our ability to make a significant impact on improving the quantity and quality of testing in the United States, we believe the Mobile Labs that offer comprehensive solutions at the site are really a key to getting outbreaks under control and providing safety to various environments. Mobile Labs open doors to significant possibilities that currently don't exist in COVID-19 testing.'

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ADMA Biologics, Inc. (NASDAQ: ADMA) announced earlier in September 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(TM) 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.

CytoDyn Inc. (OTC: CYDY) reported back in September the Phase 2 study of leronlimab for mild-to-moderate COVID-19 patients has been selected for an oral presentation at the upcoming Special isirv-Antiviral Group Conference on 'Therapeutics for COVID-19.' The Conference is sponsored by the International Society for Influenza and other Respiratory Virus Diseases, an independent and international scientific professional society promoting the prevention, detection, treatment, and control of influenza and other respiratory virus disease. "The acceptance of this oral abstract by this highly regarded scientific organization is very rewarding for all of the medical professionals who provided care and treatment to the COVID-19 patients during our Phase 2 trial. We also view this acceptance as a validation of leronlimab as a potential therapeutic for this disease and we look forward to the upcoming interim analysis from our Phase 3 trial for severe-to-critical COVID-19 patients," said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

Moderna, Inc. (NASDAQ: MRNA) announced back in September the Canadian Government has increased its confirmed order commitment to 20 million doses of Moderna's vaccine candidate against COVID-19, mRNA-1273. This updated agreement comes as Moderna's Phase 3 COVE study has enrolled more than 75% of its participants, 11,879 of whom have received their second vaccination as of September 18, 2020. To provide additional transparency in the context of the pandemic, the Company also made the complete, unredacted protocol for the Phase 3 trial of mRNA-1273 available online on Thursday, September 17. "We appreciate the confidence in Moderna's mRNA platform and the progress we are making with mRNA-1273, as demonstrated by the increased order from the Canadian government today," said Stephane Bancel, Moderna's Chief Executive Officer. "This support, along with that of our stakeholders, drives us forward as we scale-up our global manufacturing and distribution network."

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