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Companies Search for More Efficient Ways to Diagnose Viral Diseases

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NEW YORK, Aug. 5, 2020 /PRNewswire/ -- The pandemic has drastically changed the world's social and economic landscape, and it's unclear what the next steps are in combating the spread of the viral infection. The United States President is pushing for school to reopen this fall, claiming that "a permanent shutdown was never the strategy, which would ultimately lead to greater mortality and irreversible harm." Yet concerns remain that opening school could ignite a more severe second wave. Scientists are claiming that even though the U.S increased testing capacity from about 100,000 per week in mid-March to more than 5 million per week in late July, the country fell further behind in stopping the spread of the virus. Now, there is a push to change the testing strategy. According to a report by the Science Magazine, such a change in testing strategy would mean a stop to diagnosing people who have symptoms or were exposed and more toward screening whole populations using faster, cheaper, sometimes less accurate tests. "By making it possible to identify and isolate infected individuals more quickly, proponents say, the shift would slow the virus' spread, key to safely reopening schools, factories, and offices," the report indicates. Todos Medical Ltd. (OTC: TOMDF), Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Co-Diagnostics, Inc. (NASDAQ:CODX), iBio, Inc. (NYSE:IBIO

Some changes to testing are already being made. According to a report by the HILL, a bipartisan group of governors from six states have entered into a partnership to purchase and use rapid virus testing kits. The governors are from the states of Virginia, Louisiana, Massachusetts, Michigan, Ohio and Maryland. "Widespread testing is one of the most crucial tools we have to stop the spread of this virus and save lives," Michigan Gov. Gretchen Whitmer, said in a statement. "I'm hopeful that the president and Congress will follow our lead and work together on a recovery package that includes support for states like ours so we can continue to protect our families." Besides political progress, innovations and other measures are also being announced. Several biotechs, as well as medical device companies, have made reported that vaccines are being developed or testing kits are in production. 

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news yesterday that, "it has appointed Jorge Leon, Ph.D. as consulting Chief Medical and Scientific Officer (CMSO) for Infectious Disease and Oncology. Dr. Leon has served as Todos' medical advisor since July 2019.

'As medical advisor I have been able to follow Todos' progress over the last year as they've continued to build their exciting pipeline of diagnostics for cancer and Alzheimer's disease,' said Dr. Leon. 'The approach Todos has taken to enter COVID-19 testing has been spot on, by focusing on an accurate, scalable and diverse product portfolio, coupled with reliable access to the key instrumentation needed to equip a large number of labs and supply them with the reagents and consumables needed to make a meaningful increase to PCR testing capacity in the United States.

'As we now have a clear framework from the U.S. Food and Drug Administration (FDA) to gain Emergency Use Authorization (EUA) for COVID+influenza A/B and COVID pool testing, we believe we are entering the fall with the right portfolio to become a significant player in the space,' he added. 'We intend to begin to establish combined screening and reflex testing strategies using antigen, antibody and PCR pooling testing to screen patients and ultimately confirm the suspected COVID-19 cases with PCR testing. Todos is also developing an innovative saliva-based molecular test that could deliver point-of-care results in under five minutes, using a smartphone camera and software, which would represent a major advancement for the field. We expect to initiate clinical validation of that test in August in Israel with the hopes of gathering sufficient data to submit an EUA.'

Dr. Leon is internationally recognized for his pioneering work in molecular diagnostics. He holds a Ph.D. in cellular and molecular biology from New York University, and completed his postdoctoral studies at the German Cancer Research Center in Heidelberg and Columbia University in New York. Dr. Leon's subsequent academic research at Columbia University focused on developing monoclonal antibody-based tumor marker assays and radio-immuno imaging devices, which are currently in wide use.

In the early 1990s, Dr. Leon played an integral role in establishing and leading the molecular diagnostics laboratories at Quest Diagnostics. As Director of Molecular Diagnostics, Senior Director of Biotechnology Development and Vice President of Applied Genomics, Dr. Leon spent 12 years developing Quest's molecular diagnostics strategy, which is now the world's largest molecular diagnostics service laboratory. In 2003, Dr. Leon founded Leomics Associates, Inc., a consulting firm committed to helping prestigious, successful companies and academic institutions develop molecular diagnostics and personalized medicine in the United States and globally. Dr. Leon specializes in identifying breakthrough opportunities and industry trends, and helps start-up businesses, academic centers and established companies successfully build and commercialize innovative business strategies, product pipelines and test menus.

'Dr. Leon becoming more active with Todos' management team adds significant intellectual capacity to develop the protocols to use available testing tools in combination to solve the testing challenges in the United States,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'We look forward to bringing Jorge into key discussions with our partners to deploy COVID-19 testing nationwide.'

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

Moderna, Inc. (NASDAQ:MRNA) announced last week that the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants. The Phase 3 study, called the COVE (Coronavirus Efficacy) study, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. "We are pleased to have started the Phase 3 COVE study," said Stephane Bancel, CEO at Moderna. "We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic."

Novavax, Inc. (NASDAQ:NVAX) announced yesterday Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID–19 vaccine with and without Matrix–M™ adjuvant in healthy adults 18-59 years of age. NVX–CoV2373, the Company's recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org. "The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well–tolerated COVID-19 vaccine with a robust immunogenicity profile," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "Using a stringent wild-type virus assay performed by investigators at the University of Maryland School of Medicine, NVX–CoV2373 elicited neutralizing antibody titers greater than those observed in a pool of COVID–19 patients with clinically significant disease."

Co-Diagnostics, Inc. (NASDAQ:CODX) earlier in May announced the publication of a paper showing its Logix Smart™ COVID-19 Test Kit was used to demonstrate that the SARS-CoV-2 virus can be detected in cancer tissue of coronavirus patients, even before symptoms occur. The peer-reviewed paper, published in the Journal of Clinical Pathology, described a study performed at the European Institute of Oncology in Milan, Italy. Researchers used the Company's test to determine whether SARS-CoV-2 was present in the removed tumor of a man who later become symptomatic and was diagnosed with COVID-19. "We are pleased that the quality of our innovative Logix Smart COVID-19 test kit has been demonstrated once again by this impressive and important study," said Dwight Egan, Co-Diagnostics CEO. "Being able to detect the presence of the virus before symptoms even occur illustrates the sensitivity and value of our test, especially in new sample types. The world needs every advantage we can get in our battle against this deadly disease, and we believe our test has the attributes needed to benefit millions across the globe."

iBio, Inc. (NYSE:IBIO) reported back in June that IBM Watson Health has selected iBio to receive 18 months of use of the IBM Clinical Development (ICD) solution, free-of-charge. IBM Watson Health recently began offering its ICD solution to eligible trial sponsor organizations as part of its efforts to help support the medical community to address the COVID-19 pandemic. IBM Watson Health has received interest in the offering from numerous hospitals, sponsors, contract research organizations and academic institutions, and is currently enabling 15 COVID-19 disease trials. "We are deeply appreciative of IBM's vote-of-confidence, which recognizes the potential of iBio's COVID-19 vaccine development efforts from among the hundreds of organizations that applied for access to IBM's ICD solution," said Tom Isett, Co-Chairman & CEO of iBio. "This technology helps to support the rapid and efficient undertaking of clinical trials of iBio's COVID-19 vaccine candidates. It also complements our FastPharming System's core speed, quality and scale-up advantages in the development of vaccines and therapeutics. Through strategic collaborations like this one, we believe iBio is now poised with the tools, technology and capital necessary to compete in the fight against COVID-19."   

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