- 3DMed test demonstrated 99.3% sensitivity and 100% specificity in Chinese clinical trial
- Nucleic Acid test performed on proprietary automated platform to increase throughput
- CE Mark and China FDA approval have been received; 3DMed in discussions with US FDA and WHO
- Technology was deployed in Wuhan, China with over 100,000 tests completed
- Combination coronavirus and influenza A/B testing novel among PCR approaches
REHOVOT, Israel and New York, NY, March 17, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Todos Medical Ltd. (OTCQB: TOMDF), a pre-commercial stage in-vitro-diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, today announced that it has entered into a non-exclusive distribution agreement with 3DMedicine Science & Technology Co (3DMed), a China-based cancer precision medicine company, for distribution in the US and Israel of 3DMed’s ANDiS® SARS-CoV-2 Detection Kit (COVID), ANDiS® SARS-CoV-2 & Influenza A/B Detection Kit (COVID/Flu) and its proprietary ANDiS®350 3DMed Automated Solution countertop real-time PCR machine (3D Machine). 3DMed’s COVID, COVID/Flu and 3D Machine have received a CE Mark in Europe. 3D Machine also has received approval from the Chinese FDA. 3DMed is currently engaged in discussions with the FDA regarding approval of its products.
“I am very pleased to help Todos and 3DMed bring this technology forward for commercial launch in the US under CLIA, and help support FDA approval for 3DMed’s suite of products here in the United States as quickly as possible,” said Jorge Leon, PhD, Chief Medical Advisor to Todos. “The main differentiation in the 3DMed offering vs. other nucleic acid PCR-based testing is the influenza A and B tests combined with coronavirus testing. This is a clinically meaningful combination because of the extended flu season in the United States that will create additional doubt among healthcare providers regarding the cause of symptoms for patients. The fact that this will be available in one testing paradigm seems to be novel in the United States.”
Concurrent with this announcement, Todos and Provista Diagnostics, Inc. have agreed to use Provista’s lab in Alpharetta, Georgia to conduct the CLIA validation required to launch the test in the United States. All inquiries should be directed via email to covidtesting@provistadx.com. Rao Mulpuri, PhD, MBA Chief Operating Officer of Provista, commented, “Todos Medical and Provista Diagnostics will work together to complete the validation and make the product available to healthcare providers in a timely manner.”
3D BioMed has shipped materials to the Provista lab in Georgia in order to support the validation being conducted over the coming weeks.
“PCR is the current gold standard for diagnosing novel coronavirus in the United States and abroad,” said Gerald Commissiong, President & CEO of Todos. “We believe 3DMed’s ANDiS® 350 and kits provide some of the best results in the market because of the engineering applied in establishing the automation that reduces variability and human error in the lab, while increasing throughput. We intend to work expeditiously to validate this technology at Provista, so that we can come online in the US and add additional critically needed testing capacity to the nation’s infrastructure.”
“The 2019-20 coronavirus pandemic becomes an ongoing global pandemic of coronavirus disease. We have got many lessons in coronavirus fighting in Wuhan, China in the past few months and want to share the experiences with the rest of the world. Fully automated viral RNA extraction systems and precise nucleic acid detection kits played critical roles in rapidly diagnosing coronavirus disease 2019 with a large scale in Wuhan, China,” said Simon Shung, President & CEO of 3DMed. “Meanwhile, to distinguish between early symptoms of the flu and coronavirus would become very important since people may feel similar to those suffering from their symptoms. We hope to help the US and other countries stop the coronavirus spreading through the collaboration with Todos by doing more precise nucleic acid tests with our products, which were validated by tons of cases in the past few months.”
“We’re thrilled to work with Todos, a well-recognized innovative Dx company,” said Caifu Chen, Chief Technology Officer of 3DMed. “Two young technology companies share common goals in fighting cancer and now the new global 2019-nCoV epidemic brings us together to stop its spreading by precisely identifying virus infected individuals using highly sensitive and specific proprietary RT-qPCR assays developed at 3DMed. Our past experiences in catching this terrible virus in Wuhan areas will help Todos build high-performance 2019-nCoV test labs in the US in a record time.”
About Todos Medical Ltd.
Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer's disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer’s influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company’s two cancer screening tests, TM-B1 and TM-B2, have received the CE mark. Todos owns 19.99% of Breakthrough Diagnostics, Inc., a joint venture with Amarantus Bioscience Holdings, Inc. (OTCPK:AMBS) that is developing the LymPro Test®, a blood test for diagnosing Alzheimer’s disease. Todos has exercised its option to acquire Breakthrough, and expects to close on that transaction in the first half of 2020. Todos has also entered into an exclusive option to acquire breast cancer blood testing company Provista Diagnostics, Inc. that is commercializing the Videssa® breast cancer blood test.
For more information, the content of which is not part of this press release, please visit http://www.todosmedical.com
About 3DMed
3D Medicines (3DMed), founded in 2010, is a leading precision medicine company in China with a vision to provide earlier and precision diagnosis to each patient. 3DMed’s set the standard for innovation in automated molecular diagnostic products and artificial intelligence (AI) to help doctors provide patients with personalized and precision treatments. 3DMed has a College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified laboratory to provide clinical tests in various applications. 3DMed is constantly innovating and evolving its capabilities in automating and streamlining molecular diagnostic processes and genome data analysis. In 2018, 3DMed offered an AI-based cancer genome data interpretation system, ANDiS® Genome Insight. Later in 2019, 3DMed launched the world’s first fully closed automated NGS library-prep system, ANDiS® 400 into the clinical market. 3DMed is dedicated to be a game changer in automated molecular diagnostics.
At the early stage of the outbreak of coronavirus 2019 (COVID-2019) in Wuhan, Hubei Province in China, 3DMed developed a series of real-time RT-qPCR based tests (ANDiS® SARS-CoV-2 Detection Kit , ANDiS® SARS-CoV-2 & Influenza A/B Detection Kit) to qualitatively detect nucleic acids of SARS-CoV-2 in upper and lower respiratory specimens collected from individuals who meet CDC criteria for COVID-19 testing.
For more information, the content of which is not part of this press release, please visit http://www.3dmedcare.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
Corporate Contact
Daniel Hirsch
Todos Medical
Investor Relations
Email: Dan.h@todosmedical.com
Phone: (347) 699-0029