Todos Medical Expands Extraction Reagent and ANDiS 350 Extraction Automation Capacity to Support COVID-19 Testing in the USA
GlobeNewswire GlobeNewswire•July 10, 2020
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
GlobeNewswire GlobeNewswire•July 10, 2020
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
