New Testing Methods Help Ease Diagnostic Burdens in Healthcare

FinancialBuzz.com News Commentary

NEW YORK, Aug. 10, 2020 /PRNewswire/ -- As healthcare systems come under severe pressure from the pandemic, significant changes to their infrastructure are required. In particular, technological changes to transform service delivery and scale up the utilization of digital systems are key factors that currently lacking. In addition, effective and mass testing is necessary to come up with a proper plan to reduce case numbers. Now, various companies from a vast field of industries, including biotechs, medical device manufacturers, tech conglomerates and others have all made various announcements of products or services related to the pandemic, with testing kits playing a key role. Developments have been made in the testing segment, as diagnostic testing has improved over the course of the last several months. By test type, the rapid antigen test is likely to hold a substantial market share in 2020. Antigen assays are also usually more cost-effective when compared to either molecular or culture techniques. And, overall, the global rapid test kit market for the viral pandemic is expected to reach USD 3.91 Billion by 2027, according to a new report by Reports and Data. Todos Medical Ltd. (OTC: TOMDF), Vir Biotechnology, Inc. (NASDAQ: VIR), Moderna, Inc. (NASDAQ: MRNA), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Gilead Sciences, Inc. (NASDAQ: GILD)

New York is a good example of how excessive testing can influence policy. In recent days, Governor Cuomo talked about the need for strong testing protocols for schools, when students first return or if an outbreak were to happen in a classroom. "We have more testing than any other state. The data has to say it's safe to reopen, and then you need plan for every school district, every school, to have the testing in place, to have the protocols in place," the Governor explained. "There's no secret to how a virus spreads - this is mathematics, this is science and this is a function of our behavior, which we see reflected in the daily numbers. New Yorkers worked hard to change our behavior and bring the numbers down to the levels we have been holding at through our phased reopening."

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week regarding, "sales of more than $550,000 for the month of July. Sales were driven by 3D Med ANDis auto-extraction machine and 3D Med RNA extraction reagent purchases by US CLIA laboratories ramping up RT-PCR testing capacity. During July, Todos billed laboratory partners in Florida, Illinois, North Carolina, Pennsylvania, Texas and Wisconsin, addressing areas where cases of COVID-19 have recently surged.

'I'm pleased to report the recognition of COVID-19 test revenue and the momentum established by entering into key strategic partnerships with medtech industry leaders in the United States,' said Gerald E. Commissiong, President & CEO of Todos. "Our go-to-market strategy involves increasing our install base of 3D Med extraction systems that leads to ongoing reagent purchases with labs that are steadily increasing their testing capacity. From there, as our customers see the value in the quality and the speed of turnaround times for delivery; we believe they will seek to purchase additional products, including swab/viral transport media and our highly accurate qPCR test kits.'

Mr. Commissiong continued 'The next phase of growth that we are seeing increasing demand for in August is our more comprehensive end-to-end packages, including RNA auto-extraction and RT-PCR machine and all the consumables required to run RT-PCR testing. There is a clear focus on adding testing capacity in the US heading into the fall season. CLIA Labs are looking for alternatives to existing established players in the market who are struggling to provide reliable delivery of machines and consumables for PCR testing, putting labs in a position where they cannot timely deliver for their clients. Being able to deliver quickly and consistently is how we are beginning to take US market share at a time when there is an increasing national focus in the US on increasing COVID testing capacity and reducing turnaround times. We intend to vigorously expand our customer base, as well as add complementary best-in-breed COVID testing products, such as antibody and antigen testing products, so that labs may provide more comprehensive solutions for their customers. We believe there is meaningful opportunity for Todos to add significant testing capacity to the U.S. healthcare system for COVID-19 as well as for other diseases, and we intend to vigorously pursue multiple products and disease categories.'

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

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Vir Biotechnology, Inc. (NASDAQ: VIR) reported back in May that is has finalized a process development and manufacturing agreement with Biogen Inc. based on the letter of intent that the companies announced in March. Under the agreement Biogen will perform process development activities and specified manufacturing and process transfer services to enable commercial supply of Vir's SARS-CoV-2 monoclonal antibodies. "Biogen's world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximize the yield of each manufacturing batch produced," said Michael Kamarck, Ph.D., Chief Technology Officer of Vir. "The willingness of both Vir and Biogen to begin work before the definitive agreement was in place exemplifies our shared commitment to working in unconventional ways in the interest of the public good, and mutual recognition that bringing these therapies to people at the speed and scale that is needed requires the combined resources of multiple collaboration partners and significant manufacturing capacity."

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."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced back in June positive interim clinical data of INO-4800, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase 1 clinical trial cohorts. In addition, INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021. Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence. Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO would like to thank all of the trial participants and the investigator staff who have made this trial possible. We are very encouraged by the positive interim safety and preliminary cellular and humoral immune response results to date as well as the inclusion of INO-4800 in Operation Warp Speed. We are also pleased that INO-4800 vaccination abrogated viral replication in the lungs of mice challenged with SARS-CoV-2. We look forward to urgently advancing INO-4800, as it is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic."

Gilead Sciences, Inc. (NASDAQ: GILD) announced earlier last month additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir. The data are being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) and include a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care ? an important finding that requires confirmation in prospective clinical trials. Separate subgroup analyses from the Phase 3 SIMPLE-Severe trial, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, found that traditionally marginalized racial or ethnic groups treated with remdesivir in this study experienced similar clinical outcomes as the overall patient population in the study.

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