On Mar. 24, 2020, Emerald Organic Products and Todos Medical announced the creation of Corona Diagnostics, a joint venture partnership formed to address the much-needed demand for COVID-19 screening and diagnostic testing in the U.S. 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.