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Todos Medical Expands Extraction Reagent and ANDiS 350 Extraction Automation Capacity to Support COVID-19 Testing in the USA

·7 mins read


  • Full US use of ANDiS 350 extraction systems would increase US daily testing capacity by 25%

  • 3D Med extraction capacity increased by 1,000,000 kits per week

  • Extraction reagent and automation scarcity spiking as US COVID-19 PCR demand surges

  • 3D Med system successfully completes ‘pool testing’ validation for ANDiS 350

  • Todos gains branding rights to 3D Med COVID-19 products in the United States

REHOVOT, Israel, NEW YORK, NY and Shanghai, China, July 10, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE --Todos Medical Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on the distribution of a comprehensive suite of solutions for the screening and diagnosis of COVID-19 and the development of blood tests for the early detection of cancer and Alzheimer’s disease, today announced that it has expanded its agreement with 3D Medicines Corporation for COVID-19 testing products.

Under the terms of the newly signed Medical Device Contract Manufacturing Agreement, Todos has been granted the exclusive right to seek out US Food & Drug Administration (FDA) Emergency Use Authorization (EUA) for 3D Med’s SARS-CoV-19 and, as well as exclusive branding and distribution rights to 3D Med’s qPCR test kits in the United States. 3D Med recently completed an expansion of its extraction reagent manufacturing capacity, by adding 1,000,000 extraction reagent production per week (~140,000 per day) that can be used towards deployment in the US.

The current daily testing volume in the United States is approximately 550,000 tests/day. The full deployment of 3D Med’s additional extraction capacity would allow for an increase of approximately 25% in total US testing capacity per day. Todos has completed validation of 3D Med’s qPCR kits and pre-loaded extraction reagents and automated machines at its partner CLIA/CAP certified lab Provista Diagnostics, Inc. in Alpharetta, GA.

Additionally, 3D Med has successfully validated ‘pool testing’ at a ratio of 10:1, and Todos intends to complete ‘pool testing’ validation here in the United States in the next several weeks so that it can seek US FDA EUA over the summer of 2020 and be ready to deploy pool testing broadly for Back to School and Return to Work testing, which Todos expects to ramp up significantly in the second half of Q3/2020. Pool testing of 10:1 would potentially increase capacity to a maximum of 1,400,000 tests per day.

“It is now unequivocally clear that PCR testing is the gold standard in the United States for the foreseeable future, until new molecular technologies are able to reach the scale of current PCR testing,” said Gerald Commissiong, President & CEO of Todos Medical. “We are very pleased with the relationship we are building with 3D Med, especially as we see demand for extraction machines and reagents begin to really take off as smaller, independent labs begin to get involved in COVID-19 testing and they identify access to a stable supply of extraction reagents as the rate limiting step to market entry. We have started to ramp up sales, including a recent marquee sale of our ANDiS machines to the Cleveland Clinic, and we are now helping our clients get up and running so they can quickly expand their testing capacity. As we move into the next phase of growth for our emerging COVID-19 testing business, we are upselling our growing install base with Gnomegen qPCR kits and related materials so that Todos can compete effectively with competitors who tend to be focused on national and regional labs in the US. Our small and medium sized lab customer base greatly appreciates the availability of our extraction equipment and reagents.”

Separately, Todos expanded its international distribution rights to 3D Med’s COVID-19 testing products to include the United States, Israel, Singapore, Malaysia, Indonesia, Thailand, Myanmar, Vietnam, Philippine, Cambodia/Laos, Hong Kong, Japan, South Korea, Taiwan, India, United Kingdom, France, Sweden, Italy, Germany, Romania, Austria, Monaco, Switzerland, the Balkans, India, Gulf States, Dubai, UAE, Argentina, Aruba, Bahamas, Barbados, Belize, Bolivia (Plurinational State of), Mexico, Canada, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Martinique, Grenada, Guatemala, Guyana, Haiti, Honduras, Jamaica, Nicaragua, Panama, Paraguay, Peru, Saint Kitts and Nevis, Suriname, Trinidad and Tobago, Uruguay, Venezuela (Bolivarian Republic of), Dominican Republic of Congo, Madagascar, Zimbabwe, Lesotho, Botswana, Angola, Zambia and South Africa.

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

For testing and PPE inquiries, please email sales@todosmedical.com

About Todos Medical Ltd.

Headquartered in Rehovot, Israel, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe and are currently in a pre-commercial study with its distribution partner Orot+ (a division of Luces-Orot). Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

Through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Todos is also actively involved with the development of blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. Todos expected to complete the remaining unowned interest in Breakthrough in the third quarter of 2020.

Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The Company has entered into distribution agreements with multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos, via its wholly-owned subsidiary Corona Diagnostics LLC, has formed strategic partnerships with Meridian Health, Moto-Para Foundation, Emerald Organic Products, Inc.’s (OTC: EMOR) subsidiaries Carie.com and Bonsa Health to help deploy COVID-19 testing in the United States.

For more information, please visit https://www.todosmedical.com/

Forward-looking Statements

Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.

Investor and Corporate Contact:

Kim Sutton Golodetz

LHA Investor Relations

Senior Vice President

(212) 838-3777

kgolodetz@lhai.com


Corporate Contact:

Daniel Hirsch

Todos Medical

(347) 699-0029

Dan.h@todosmedical.com