Companies Look to Improved Diagnostic Solutions as a Means to Return to Normalcy

NEW YORK, Sept. 23, 2020 /PRNewswire/ -- Because of the pandemic and the pressures the healthcare industry has to go through, various sectors within the industry have had to innovate in the field of vaccination, PPEs, medical devices and mass testing. The Food and Drug Administration (FDA) emphasized the importance of testing capabilities back in March and 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." Todos Medical Ltd. (OTC: TOMDF), Moderna, Inc. (NASDAQ: MRNA), BioNTech SE (NASDAQ: BNTX), Novavax, Inc. (NASDAQ: NVAX), FLIR Systems, Inc. (NASDAQ: FLIR)

In response to the outbreak, governments around the world have focused their resources on curing the viral infection. 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 yesterday that, "it has rapidly expanded its agreement with a Wisconsin-based laboratory to supply it with the necessary testing equipment and supplies to ramp up to 12,000 tests a day, for a total contract value of $47.5 million in reagent sales by Todos Medical over the next seven months. Todos will be supplying automated extraction machines, liquid handlers and PCR machines. 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.

'As we are now midway into the implementation phase with this client, we are seeing how increasing their testing capacity is being met with the pent up demand for PCR testing services from this client, especially from skilled nursing facilities,' said Gerald Commissiong, President & CEO of Todos. 'There is tremendous nationwide demand for COVID-19 testing services and solutions in skilled nursing facilities. As we begin to make in-roads in developing this sales channel for our COVID test, we expect that we will be able to tailor programs using combinations of testing that allow for screening and diagnosis. We expect nursing homes and skilled nursing facilities to play a major part of our COVID-19 testing strategy. Additionally we believe this will pave the way for the deployment of our immune-based Alzheimer's blood diagnostic LymPro Test(TM).'

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

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Moderna, Inc. (NASDAQ: MRNA) announced on September 22nd that the Canadian Government has increased its confirmed order commitment to 20 million doses of Moderna's vaccine candidate against COVID-19, mRNA-1273. "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."

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.

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(TM) 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."

FLIR Systems, Inc. (NASDAQ: FLIR) announced on June 30th, modified thermal cameras for fast and safe non-contact elevated skin temperature* screening. The FLIR EST(TM) thermal screening solutions provide frontline screening at building entries and in high traffic areas to improve safety and help curb the spread of COVID-19. The FLIR Axxx-EST, FLIR T5xx-EST, and FLIR Exx-EST series cameras are designed to simplify the screening process, reducing the burden on screening operators and adhering to recommended social distancing guidelines. "The new FLIR EST thermal solutions represent nearly two decades of experience designing and manufacturing thermal measurement solutions for skin temperature screening," said Jim Cannon, President and CEO at FLIR. "These cameras are our easiest cameras to set up and operate to date for skin temperature screening, requiring limited training to begin screening people more quickly and accurately."

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