Testing is in High Demand as Spread of Infection Remains

NEW YORK, Sept. 1, 2020 /PRNewswire/ -- As the pandemic continues to spread throughout the U.S., the need for testing is on the rise. But many states and regions are experiencing a shortage of tests, which is a serious obstacle to the fight against the spread of the viral infection. Overall, testing continues to be uneven, as some states have managed to provide higher rates of testing than others. The results from the most common test, the nose swab, which is similar to various flu virus tests, are not always certain; if a test result comes back positive, it is almost certain that the person is infected. However, negative test result is less definite. An infected person could get a so-called "false negative" test result if the swab missed the virus, for example, or because of an inadequacy of the test itself. Antibody testing however, which requires a blood sample, is gradually becoming more available. Todos Medical Ltd. TOMDF, Moderna, Inc. MRNA, Vir Biotechnology, Inc. VIR, Novavax, Inc. NVAX, AstraZeneca Plc AZN

As healthcare systems come under severe pressure from the pandemic, significant changes to their infrastructure are needed and being implemented. In particular, effective and mass testing is necessary to ensure the strategies implemented to fight the pandemic are effective. The Food and Drug Administration (FDA) emphasized the importance of testing capabilities back in March. According to the FDA's announcement, it has issued the fourth diagnostic related Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath Combo Kit. FDA Commissioner Stephen M. Hahn, M.D explained that "We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process." Now, various companies from a vast field of industries, including pharmaceuticals, medical device innovators and others have all made various declarations regarding products or services related to the pandemic, with testing kits at the center of attention.

Todos Medical Ltd. TOMDF announced breaking news yesterday that, "it has entered into a sales agreement with a Wisconsin-based laboratory to supply it with the necessary testing equipment and supplies for a total contract value of $23.76 million. Todos will be supplying automated extraction machines, liquid handlers and PCR machines. The initial contract is for 8 months. Todos has also been granted a priority right to supply the lab with up to 100,000 COVID PCR tests per day in the event the laboratory sees significant additional testing demand. This customer has entered into an agreement with the State of Wisconsin to supply COVID-19 PCR tests.

'We assisted this client get into testing in July with initial ANDis 350 automated extraction machines and reagents, and steadily worked with them to increase their capacity, as well as meet certain quality criteria required of state contractors,' said Gerald Commissiong, President & CEO of Todos. 'We are extremely gratified that this work has paid off and we've been a key part of enabling this client to gain a transformative agreement that will allow them to grow dramatically heading into the fall of 2020, when we expect demand for PCR testing to increase as a result of more widespread availability of antigen screening tests that will require PCR confirmation. We expect this is a trend that will continue in the weeks and months ahead as states look to secure confirmatory testing capacity.'

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

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd. recent corporate news, please head over to: https://www.youtube.com/watch?v=msW5MbyH5Bs

Moderna, Inc. MRNA announced last month that the U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government's goal of securing early access to safe and effective COVID-19 vaccines for the American people. Today's award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, today's announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. Under the terms of the agreement, the U.S. government, as a part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna. The U.S. government has announced that consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.

Vir Biotechnology, Inc. 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."

Novavax, Inc. NVAX and Takeda Pharmaceutical Company Limited announced last month a partnership for the development, manufacturing and commercialization of NVX–CoV2373, Novavax' COVID–19 vaccine candidate, in Japan. NVX–CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix–M™ adjuvant. Takeda will receive funding from the Government of Japan's Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year. "Takeda's leading position in Japan, technical expertise, regulatory know-how and manufacturing capacity make the company an ideal partner to further expand the global availability of NVX–CoV2373," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to collaborating with Takeda to rapidly develop, produce and commercialize the vaccine in Japan."

AstraZeneca Plc AZN concluded on August 14th, an agreement with the European Commission (EC) to supply up to 400 million doses of the AZD1222 COVID-19 vaccine. Building on the existing agreement with Europe's Inclusive Vaccines Alliance spearheaded by Germany, France, Italy and the Netherlands, this new agreement will give all EU member states the option to access the vaccine in an equitable manner at no profit during the pandemic. It also allows EU member states to redirect doses to other European countries.  Pascal Soriot, Chief Executive Officer, said: "This first vaccine agreement with the European Commission will ensure that millions of Europeans have access to the AZD1222 vaccine following its approval. With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020. I would like to thank the entire European Commission, and especially the Commissioner for Health and Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may soon be protected with a vaccine against this deadly virus, enabling our global society and economy to rebuild."

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