Todos Medical Enters Into Distribution Partnership with Osang Healthcare for the GeneFinder Plus™ COVID-19 Plus RealAMP Kit in the United States
Todos Medical, Ltd. (OTCQB: TOMDF) announced a distribution partnership with Osang Healthcare to distribute the GeneFinder™ COVID-19 Plus RealAMP Kit in the U.S. The kit has received Emergency Use Authorization (EUA) from the FDA and is designed to detect various SARS-CoV-2 variants. Todos Medical plans to make GeneFinder Plus the primary kit for its automated COVID-19 PCR testing labs. The partnership aims to enhance testing capabilities, addressing the need for sensitive tests as the U.S. reopens.
- GeneFinder Plus has received Emergency Use Authorization from the US FDA.
- The kit demonstrates capability to detect multiple SARS-CoV-2 variants.
- Distribution partnership with Osang Healthcare enhances testing capabilities.
- Quick delivery of GeneFinder Plus kits within 48 hours of ordering.
- None.
- 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.
About Todos Medical Ltd.
Founded in Rehovot, Israel with offices in New York City, 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. 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 currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test.
Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover 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 has formed a strategic partnership with Integrated Health LLC to deploy mobile COVID-19 testing in the United States. Additionally, Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target the reproductive mechanism of coronaviruses.
For more information, please visit https://www.todosmedical.com/.
About OSANG Healthcare Co., Ltd.
OSANG Healthcare is a South Korea based global manufacturer and distributor of medical devices and in-vitro diagnostics solutions. Devoted since inception to the development of diagnostic biosensors for blood glucose measurement, OSANG Healthcare envisions medical devices becoming as commonplace as home appliances, easily measuring all diseases across the globe as "Technology for Human". OSANG Healthcare currently exports its diagnostic biosensors for blood glucose, HbA1c and cholesterol to more than 110 countries, in its drive to become the leading researcher and developer of diagnostic sensors for heart disease and cancer, and of remote diagnosis systems. For more information, visit www.osanghc.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.
Todos Investor Contact:
Richard Galterio
Ascendant Partners LLC
Managing Partner
732-642-7770
Todos Corporate Contact:
Priyanka Misra
Todos Medical
(917) 983-4229 ext. 103
OSANG Healthcare Headquarters Contact:
132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040, South Korea
Tel. +82-31-460-0300
info@osanghc.com
www.osanghc.com
OSANG Healthcare USA Contact:
Daniel Lee
dannlee@osanghc.com
FAQ
What is the significance of GeneFinder Plus receiving Emergency Use Authorization?
Which COVID-19 variants can GeneFinder Plus detect?
What is the role of Todos Medical in the distribution of GeneFinder Plus?
How quickly can GeneFinder Plus kits be delivered in the U.S.?
