Todos Medical Enters Into Distribution Partnership with Osang Healthcare for the GeneFinder Plus™ COVID-19 Plus RealAMP Kit in the United States
GeneFinder Plus has received Emergency Use Authorization from the US FDA
Analysis demonstrates GeneFinder Plus able to detect B.117, B.135, P1 and other variants
Validation ongoing with Saliva, Oropharyngeal and Nasal Sample collection
NEW YORK, NY, REHOVAT, Israel, and SEOUL, South Korea, March 30, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening, diagnosis and immune support, as well as developing blood tests for early detection of cancer and Alzheimer’s disease, today announced 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.
For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com
For testing and PPE inquiries, please email sales@todosmedical.com.
https://investor.todosmedical.com/news-events...rship-with
GeneFinder Plus has received Emergency Use Authorization from the US FDA
Analysis demonstrates GeneFinder Plus able to detect B.117, B.135, P1 and other variants
Validation ongoing with Saliva, Oropharyngeal and Nasal Sample collection
NEW YORK, NY, REHOVAT, Israel, and SEOUL, South Korea, March 30, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening, diagnosis and immune support, as well as developing blood tests for early detection of cancer and Alzheimer’s disease, today announced 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.
For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com
For testing and PPE inquiries, please email sales@todosmedical.com.
https://investor.todosmedical.com/news-events...rship-with
