FinancialBuzz.com’s latest Buzz on the Street Show: Featuring Our Corporate News Recap on “Todos Medical Enters into Coronavirus Nucleic Acid Buccal Testing Kit Distribution Agreement with 3D BioMed”
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 3D Biomedicine Science & Technology Co., a China-based cancer precision medicine company, for distribution in the US and Israel of 3D BioMed’s 3DMed 2019-nCoV Detection Kit (COVID), 3DMed 2019-nCoV & Flu A/B Detection Kit (COVID/Flu) and its proprietary ANDiS®350 3DMed Automated Solution countertop real-time PCR machine (3D Machine). 3D BioMed’s COVID, COVID/Flu and 3D Machine have received approval from the Chinese FDA and have received a CE Mark in Europe. 3D BioMed is currently engaged in discussions with the FDA regarding approval of its products.
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.
COVID-19 has drastically changed the world’s social and economic landscape since the virus was first identified in China back in January. Countries have shut down schools and businesses, restricted travel, are in the midst of canceling entertainment and sporting events, as well as encouraging the public to stay at home as much as possible. Earlier last week, the World Health Organization (WHO) proclaimed the COVID-19 outbreak a global pandemic. According to WHO Director-General’s opening remarks at the media briefing on COVID-19 on March 11th, 2020: the number of cases, the number of deaths and the number of affected countries is expected to climb even higher in the days ahead. As of Monday, more than 4,000 people have tested positive for the new COVID-19 disease in the U.S. and at least 71 have died. Worldwide, more than 169,000 people confirmed to have the virus. And while about half have already recovered, the death toll was just over 6,500 at the time of writing. In an effort to slow the spread of the coronavirus pandemic, the Centers for Disease Control (CDC) announced on Sunday that it recommends organizers (whether groups or individuals) cancel or postpone in-person events that consist of 50 people or more throughout the United States for the next 8 weeks.
Several biotechs, as well as medical device companies, have made announcements that vaccines are being developed or testing kits are in production. In the meantime, a Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. According to the National Institutes of Health (NIH), “The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine.” As for testing, labs and healthcare facilities are facing supply shortages, a lack of instrument access, as well as increased staffing needs. In response, the FDA opened the emergency use authorization (EUA) process to high-complexity CLIA labs on Feb. 28th, creating a new pathway for regulated assay development. According to the FDA’s announcement from last week, it has issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. “This action today shows our agency’s dedication to working around the clock to review and authorize diagnostics during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process.”
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