Coronavirus (COVID-19)-Focused Joint Venture Formed Between Emerald Organic and Todos Medical to Supply U.S. Market With Rapid Point-of-Care Screening and Confirmatory Testing Kits
BY PR Newswire
— 2:58 PM ET 03/24/2020
HOLBROOK, N.Y. and REHOVOT, Israel, March 24, 2020 /PRNewswire/ -- Emerald Organic Products, Inc. (OTC: EMOR) and Todos Medical Ltd. ( TOMDF Loading...) today announced the creation of Corona Diagnostics, LLC, a joint venture partnership formed to address the much-needed demand for COVID-19 screening and diagnostic testing in the United States. The joint venture will be owned 51% by Emerald and 49% by Todos.
Emerald Organic, a diversified health sciences company headquartered in New York, will contribute financing, U.S. domestic distribution know-how, international trade relationships, and assistance in navigating the U.S. healthcare and regulatory landscape.
Based in Rehovot, Israel, Todos, an in-vitro-diagnostics company focused on the development of blood tests for the early detection of cancer, neurodegenerative disorders and infectious disease, will be responsible for securing regulatory approval from the U.S. Food & Drug Administration for the Colloidal Gold COVID-19 point-of-care (POC) screening test kit ("Colloidal Gold"
currently produced in China. Additionally, Corona Diagnostics, LLC will utilize the Todos distribution agreement for the ANDiS® SARS-CoV-2 Detection Kit (COVID), ANDiS® SARS-CoV-2 & Influenza A/B Detection Kit (COVID/Flu) and a proprietary ANDiS®350 3DMed Automated Solution countertop real-time Polymerase Chain Reaction (PCR) machine (3D Machine).
Colloidal Gold is a rapid POC test that uses a drop of blood from a finger prick to determine whether an individual has produced antibodies to in response to COVID-19. The test takes between two and 15 minutes to generate results and has received a CE mark in Europe as a screening test for patients for COVID-19. Corona Diagnostics is also bringing to market an automated PCR based testing solution to use in combination with Colloidal Gold as it seeks to establish a new standard of care for COVID-19 testing in the United States. Confirmatory PCR testing requires a healthcare professional to swab the back of the nose or throat to collect a sample. The sample is then sent to a high complexity CLIA (Clinical Laboratory Improvement Amendments) lab using the PCR method to identify SARS Cov-2 viral RNA which is the cause of COVID-19. Currently, there is not enough lab capacity in U.S. to meet the needs for COVID-19 PCR testing. Corona Diagnostics expects to make multiple submissions to the U.S. FDA's Emergency Use Authorization program to secure the necessary approvals.
"One of the most effective strategies to mitigate the spread of COVID-19 is a comprehensive screening process," said Ian Parker, CEO of Emerald Organic. "We've seen great results in other countries like South Korea with this approach; however, there's an alarming shortage of screening tests available domestically right now, well below our needs. It's our hope that through Corona Diagnostics, and with combining efforts with Todos, we can relieve bottlenecks in the PCR testing process by screening patients with rapid POC tests and significantly improve the paradigm and pace of diagnosing COVID-19 infection across the U.S."
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries. COVID-19 is the disease caused SARS-CoV-2.
"Our team is working diligently to complete our CLIA validation process for the COVID-19 tests we have obtained in order to secure regulatory approval through the FDA Emergency Use Authorization program," said Gerald Commissiong, President & CEO of Todos Medical Ltd. (TOMDF Loading...) "Being able to quickly triage patients with Colloidal Gold and then quarantine those virus-infected individuals while we wait for confirmatory results from PCR testing should drastically help flatten the curve of the spread of the menacing coronavirus. More importantly, it will help healthcare professionals protect themselves while staying at work to help all patients during these unprecedented times."
https://www.prnewswire.com/news-releases/coro...29211.html
BY PR Newswire
— 2:58 PM ET 03/24/2020
HOLBROOK, N.Y. and REHOVOT, Israel, March 24, 2020 /PRNewswire/ -- Emerald Organic Products, Inc. (OTC: EMOR) and Todos Medical Ltd. ( TOMDF Loading...) today announced the creation of Corona Diagnostics, LLC, a joint venture partnership formed to address the much-needed demand for COVID-19 screening and diagnostic testing in the United States. The joint venture will be owned 51% by Emerald and 49% by Todos.
Emerald Organic, a diversified health sciences company headquartered in New York, will contribute financing, U.S. domestic distribution know-how, international trade relationships, and assistance in navigating the U.S. healthcare and regulatory landscape.
Based in Rehovot, Israel, Todos, an in-vitro-diagnostics company focused on the development of blood tests for the early detection of cancer, neurodegenerative disorders and infectious disease, will be responsible for securing regulatory approval from the U.S. Food & Drug Administration for the Colloidal Gold COVID-19 point-of-care (POC) screening test kit ("Colloidal Gold"
currently produced in China. Additionally, Corona Diagnostics, LLC will utilize the Todos distribution agreement for the ANDiS® SARS-CoV-2 Detection Kit (COVID), ANDiS® SARS-CoV-2 & Influenza A/B Detection Kit (COVID/Flu) and a proprietary ANDiS®350 3DMed Automated Solution countertop real-time Polymerase Chain Reaction (PCR) machine (3D Machine). Colloidal Gold is a rapid POC test that uses a drop of blood from a finger prick to determine whether an individual has produced antibodies to in response to COVID-19. The test takes between two and 15 minutes to generate results and has received a CE mark in Europe as a screening test for patients for COVID-19. Corona Diagnostics is also bringing to market an automated PCR based testing solution to use in combination with Colloidal Gold as it seeks to establish a new standard of care for COVID-19 testing in the United States. Confirmatory PCR testing requires a healthcare professional to swab the back of the nose or throat to collect a sample. The sample is then sent to a high complexity CLIA (Clinical Laboratory Improvement Amendments) lab using the PCR method to identify SARS Cov-2 viral RNA which is the cause of COVID-19. Currently, there is not enough lab capacity in U.S. to meet the needs for COVID-19 PCR testing. Corona Diagnostics expects to make multiple submissions to the U.S. FDA's Emergency Use Authorization program to secure the necessary approvals.
"One of the most effective strategies to mitigate the spread of COVID-19 is a comprehensive screening process," said Ian Parker, CEO of Emerald Organic. "We've seen great results in other countries like South Korea with this approach; however, there's an alarming shortage of screening tests available domestically right now, well below our needs. It's our hope that through Corona Diagnostics, and with combining efforts with Todos, we can relieve bottlenecks in the PCR testing process by screening patients with rapid POC tests and significantly improve the paradigm and pace of diagnosing COVID-19 infection across the U.S."
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries. COVID-19 is the disease caused SARS-CoV-2.
"Our team is working diligently to complete our CLIA validation process for the COVID-19 tests we have obtained in order to secure regulatory approval through the FDA Emergency Use Authorization program," said Gerald Commissiong, President & CEO of Todos Medical Ltd. (TOMDF Loading...) "Being able to quickly triage patients with Colloidal Gold and then quarantine those virus-infected individuals while we wait for confirmatory results from PCR testing should drastically help flatten the curve of the spread of the menacing coronavirus. More importantly, it will help healthcare professionals protect themselves while staying at work to help all patients during these unprecedented times."
https://www.prnewswire.com/news-releases/coro...29211.html
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