More Stringent Testing is Planned in a Bid to Return to Normalcy

NEW YORK, Oct. 14, 2020 /PRNewswire/ -- As the economy slowly resumes its activity, it is more important than ever to provide a vast and effective testing network across the country. With testing, various regulatory bodies can obtain the data necessary to help make informed decisions to keep communities safe and assist policymakers with decisions about activity levels, masking, etc... For the pandemic, there are two types of tests that are being administered. A diagnostic test, which can show if the patient has an active virus infection and should take steps to quarantine or isolate from others, and the antibody test. The latter looks for antibodies that are made by your immune system in response to a threat, such as a specific virus. Antibodies can help fight infections and take several days or weeks to develop after you have an infection, yet may stay in your blood for several weeks or more after recovery. Because of this, antibody tests should not be used to diagnose an active coronavirus infection. Additionally, at this time, researchers do not know if the presence of antibodies means that you are immune to the coronavirus in the future. Todos Medical Ltd. (OTC: TOMDF), Co-Diagnostics, Inc. (NASDAQ: CODX), Aytu BioScience, Inc. (NASDAQ: AYTU), Chembio Diagnostics, Inc. (NASDAQ: CEMI), OPKO Health company (NASDAQ: OPK)

To help inspire confidence, and bring back customers, business have started to offer various testing options. For example, according to a report by Recode, airlines including United, American Airlines, and Hawaiian Airlines are offering options for COVID-19 testing to passengers traveling to the state of Hawaii. These will include at-home tests, drive-through testing, and in-person tests at the airport. With a negative result in hand, travelers will be exempt from the state's two-week quarantine requirements for new arrivals. Kyle Potter, the editor of the travel deals website Thrifty Traveler, explained that, "For all of the countries that are off-limits to Americans — which, to be honest, is most of them — that is going to be … the condition for allowing travel to resume… Anywhere you can think of, with very few exceptions, that is going to become the norm, especially for international travel." 

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news yesterday that, "total revenues of $2.0 million for the third quarter of 2020 (the "Third Quarter"). The revenues were primarily derived from sales of ANDis 350 automated extraction machines and related extraction reagent kits, as well as deposits for ongoing reagent supply agreements.

'In the third quarter, we really strove to build a sustainable business model that would allow us to become a significant player in the COVID-19 PCR testing space, as PCR remains the gold standard for testing in the United States,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'Critically, we have received our first payments from our largest client from Wisconsin who is rapidly scaling its capacity with our solutions in the face of a marked increase in demand for PCR testing from skilled nursing clients. We have been supplying this client with sufficient reagents to perform over 2,100 tests per day over the last couple of weeks, and this week we increased the order size to over 3,500 tests per day. We are now in the process of implementing our liquid handler/ automated-extraction/ RT-PCR equipment solution with this client, and expect to build sufficient capacity in the fourth quarter of 2020 to run 84,000 tests per week to meet their existing contracted demand. We expect to start supplying them with qPCR kits in the fourth quarter that we believe will increase revenue/test by 250%.'

Mr. Commissiong continued, 'We believe emerging COVID-19 surveillance and screening solutions being deployed at greater scale will continue to increase the need for COVID-19 PCR testing. In the initial phase of implementing Todos' business model, we focused on expanding our ANDis 350 automated extraction installation base and leveraging the performance of that equipment to secure long term supply agreements with a number of core clients. As this has been accomplished, our current goal is to assist our clients to achieve rapid growth. To succeed in this regard, we recognized we must help our clients address the two major obstacles to growth, which are finding qualified staffing in a tight labor market and improving on quality control that is so vital to COVID testing. We believe we have addressed these impediments to growth on behalf of our customers by securing the purchase of liquid handlers. Each liquid handler allows for testing to be increased by a minimum of five hundred percent while improving quality control through automation with the benefit of reducing labor requirements. Additionally, we intend to add additional molecular and immune-based tests to our COVID-19 offering to allow labs and healthcare providers to better serve their clients as the science of COVID-19 evolves.'

Revenue highlights:

In the third quarter of 2020, the Company successfully transitioned its revenue from primarily big-ticket equipment sales in the first half of the third quarter, to recurring revenue from extraction reagent kit sales in the second half of third quarter. The Company is currently in the validation process with five clients who are implementing one of Todos' COVID-19 PCR lab offerings, which expand beyond extraction reagents to also include FDA EUA authorized qPCR and sample collection kits.

 July 2020: $550,000 in revenue driven primarily driven by ANDis 350 installation 
 August 2020: $1,190,000 in revenue driven primarily by deposits for PCR package 
 September 2020: $350,000 in revenue driven primarily by extraction reagents sales 
 October 2020 through October 9th: $345,00 was driven by growth in extraction reagent sales

The Company expects to generate revenue from FDA EUA approved qPCR kits sold in our PCR packages in November 2020. The Company has entered into contracts that have the potential to generate revenues of $60 million by the end of the first half of 2021. In each of the Company's contracts, the Company has a priority right to sell testing kits packages to each of its clients for at least the first 75,000 tests per day (equivalent to 525,000 tests per week).

'Provided that we continue to execute at the pace we currently are in the implementation of our lab solutions for our clients, we expect to be cash flow positive in the middle of the fourth quarter of 2020,' said Dan Hirsch, CFO of Todos Medical. 'We do not intend to effect a reverse split of the Company's common stock until we become cash flow positive in our COVID-19 testing business. The COVID-19 PCR laboratory testing market is growing significantly month over month in the United States, and we expect this trend to continue as economies reopen and we head into the fall and winter seasons when seasonal illnesses, including influenza, become more prevalent. We believe our suite of testing solutions allow us to be a one stop shop for COVID-19 testing solutions in the United States. Further, we believe the mobile labs solution that we will be supplying have the potential to scale testing capacity in areas not typically served by COVID testing and will allow for potentially ultra-rapid turnaround times, a potentially significantly valuable addition to the US testing paradigm.'

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=mY7M6tWhW-E

Co-Diagnostics, Inc. (NASDAQ: CODX) announced back in September that its Logix Smart™ ABC Test (Influenza A/Influenza B/COVID-19) is anticipated to be ready for launch to US CLIA laboratory customers the first week of October 2020. "Co-Diagnostics is committed to participating in the fight against COVID-19 through the development and manufacture of vital diagnostic testing solutions, with none perhaps as important as this upcoming ABC multiplex test," remarked Dwight Egan, CEO of Co-Diagnostics. "Our patented CoPrimer™ technology platform is ideally suited for multiplex reactions by substantially reducing 'primer-dimers,' a phenomenon in PCR molecular tests that results in false positive results. At a time when the need for accurate detection of COVID-19 as well as the differentiation between strains of the flu has never been greater, we are pleased to be able to contribute to the safety and well-being of communities across the country and around the world."

Aytu BioScience, Inc. (NASDAQ: AYTU) reported earlier in September that the Company has signed an agreement to distribute the Pinnacle CovID RAD Rapid Antigen Detection Test worldwide. The rapid antigen test, which delivers results in fifteen minutes, tests for the presence of the SARS-CoV-2 virus antigen via a nasopharyngeal sample and can be conducted without the use of laboratory equipment. Aytu BioScience, Inc., a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs announced today that the Company has signed an agreement to distribute the Pinnacle CovID RAD Rapid Antigen Detection Test worldwide. The rapid antigen test, which delivers results in fifteen minutes, tests for the presence of the SARS-CoV-2 virus antigen via a nasopharyngeal sample and can be conducted without the use of laboratory equipment.

Chembio Diagnostics, Inc. (NASDAQ: CEMI) announced back in September its initiation of the notification process and submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG. "We are pleased to have accomplished all of our objectives in the development and validation of the new DPP SARS-CoV-2 IgM/IgG test system," stated Richard Eberly, Chembio's President and Chief Executive Officer. "Submission of the EUA application for this test system has been the top priority for our organization because we understand there is a large need in the market for additional rapid tests – especially ones that offer the ability to decentralize testing locations. We are excited to offer a solution to patients and clinicians across the healthcare system that addresses these needs.

OPKO Health company (NASDAQ: OPK), announced last week the beginning of its COVID-19 testing program for New York City schools throughout the 2020-2021 school year to help ensure a safer school environment. Continuing a strategic collaboration with New York City, the Department of Health, New York City Health and Hospital Corporation (NYC Health + Hospitals), the Test & Trace Corp, and the Department of Education, BioReference is performing COVID-19 molecular testing for NYC schools. In addition, BioReference is collecting specimens from principals, teachers, administration and students from over 950 schools across NYC. "This school year for New York City and other school systems around the world is vastly different due to the global pandemic, and BioReference is privileged to aid in keeping NYC schools safe," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories.

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