News Commentary

New York, NY (3/31/2021) – The pandemic is still a very real threat as the number of new cases spiked in the United States once again. Data provided by Johns Hopkins University indicates that U.S has averaged 65,700 new cases a day over the last week, a 22% jump from the week prior, when the number was near 2021’s lowest point. Dr. Abdul El-Sayed, a former health commissioner for Detroit, explained according to a report by CNN, that “vaccines don’t work until they hit people’s arms – and we just don’t have enough vaccinations in people’s arms yet to be able to achieve the kind of herd immunity that we need.” Todos Medical Ltd. (OTC: TOMDF), Fluidigm Corporation (NASDAQ: FLDM), Hologic, Inc. (NASDAQ: HOLX), Moderna, Inc. (NASDAQ: MRNA), BioNTech SE (NASDAQ: BNTX)

The Director of the U.S. National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, and many other experts have warned that rapid reopening and lifting of pandemic restrictions in many states, as well as the proliferation of more contagious variants, will likely result in ongoing and increased spread of the virus in hot spots around the country. The increase in numbers further proves that mass scale testing is still a crucial component in the fight against the pandemic. Late last year, the FDA finally approved the first diagnostic at-home self-test that provides rapid results. FDA Commissioner Stephen Hahn said, “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news that, “it has entered into a distribution partnership with Osang Healthcare (OHC) of South Korea, to distribute the GeneFinder™ COVID-19 Plus RealAMP Kit in the United States. Todos intends to make GeneFinder Plus the primary kit used for distribution in its fully integrated and automated COVID-19 PCR testing lab solutions. GeneFinder Plus has been granted Emergency Use Authorization (EUA) by the US FDA.

“We are very pleased to enter into this partnership with OHC surrounding the distribution of GeneFinder Plus, one of the most sensitive kits to have received EUA from the US FDA,” said Gerald Commissiong, President & CEO of Todos Medical. “As PCR testing becomes more ingrained as the country re-opens, the emergence of new SARS-CoV-2 variants makes regulatory oversight of reagents that much more critical in the CLIA laboratory testing space. We intend to work closely with Osang to expand the use of GeneFinder Plus to include saliva testing, an area we see as critical for serial testing given its ease of use for children and healthy adults.”

“The data indicate that GeneFinder Plus has an exquisite lower limit of detection (LOD), suggesting that it is able to identify SARS-CoV-2 at the very earliest stages of infection,” said Jorge Leon, PhD, Chief Medical Officer for Oncology and Infectious Diseases at Todos Medical. “As PCR testing in the United States moves towards a standard serial testing paradigm in school, offices, sporting leagues and other areas of society preparing to re-open, it will be more and more critical that highly sensitive tests are used in order to identify infection early, and thus limit the spread. The LOD of GeneFinder Plus, and its ability to identify infection with all the known variants currently circulating in the United States, makes it well suited to promote as part of our offering tailored towards schools.”

“We are delighted with the Todos distribution partnership, especially now that we have established manufacturing in the USA,” commented Dong-Hyun Lee, Chairman & Chief Executive Officer of OSANG Healthcare Co., Ltd. “As a result of our newly established supply chain in the United States, we will be able to deliver GeneFinder Plus kits anywhere in the US within 48h of ordering, a critical component to the ‘just in time’ supply chain many labs need, to manage the cold chain requirements of PCR testing.”

OHC’s test is designed to detect SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus 2), the virus that causes COVID-19, through a gene-based reverse transcription reaction and real-time polymerase chain reaction (RT-PCR) testing process that can provide 384 test results per PCR machine in just over two hours. Todos has been granted sales, marketing and distribution rights to OHC’s product in the United States and plans to leverage its customer base of labs performing high capacity COVID testing.
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Fluidigm Corporation (NASDAQ: FLDM) announced on March 1st, that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the AZOVA™ COVID-19 Test Collection Kit for use with the Fluidigm® Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the company’s Biomark™ HD platform. “We are excited about this collaboration with Fluidigm,” said Cheryl Lee Eberting, MD, Founder and CEO of AZOVA. “Our goals are to enable any CLIA-certified laboratory that meets the requirements to perform high-complexity tests to process our home collection kits, and to make this kit accessible to as many consumers as possible. By combining a powerful digital health platform with this assay, AZOVA and Fluidigm are opening up much greater access to COVID-19 testing solutions.

Hologic, Inc. (NASDAQ: HOLX) announced last October that it has been awarded a $119 million contract from the United States government to expand its production capacity for COVID-19 molecular tests. The contract will support capital and labor investments enabling Hologic to provide 13 million COVID-19 tests per month for the U.S. market by January of 2022. “Hologic has already made significant investments in our test production capacity, which have resulted in our contributing tens of millions of COVID tests to the United States supply,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “Our manufacturing teams continue to innovate to increase our contribution, and we are very pleased to partner with the federal government to further our ability to meet the ongoing public health need.”

Moderna, Inc. (NASDAQ: MRNA) announced on March 29th, that the Company has shipped the 100-millionth dose of its COVID-19 vaccine to the U.S. Government. More than 67 million doses of the Moderna COVID-19 Vaccine have been administered in the U.S., according to the U.S. Centers for Disease Control and Prevention1. “I would like to thank the millions of people who have put their confidence in Moderna’s science and our COVID-19 vaccine. We are encouraged by the fact that more than 67 million doses have been administered in the U.S. and we are humbled to know that we are helping address this worldwide pandemic with our vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I would also like to thank the Moderna team, our suppliers and our U.S. manufacturing partners including Lonza and Catalent, for their tireless and extraordinary work in completing this important milestone.”

BioNTech SE (NASDAQ: BNTX) and Pfizer Inc. announced on March 26th, that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers. The new data is a testament to the companies’ ongoing commitment to developing this vaccine further and collecting data in order to support broader and more flexible vaccine distribution and inoculation. “From the beginning our goal was to make our vaccine broadly available to people around the world. This approval by the EMA will enable us to access important additional channels to distribute and administer our vaccine,” said Ugur Sahin, CEO and Co-founder of BioNTech. “It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic.”

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