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Todos Medical Enters Into Direct Exclusive Distribution Agreement With Gnomegen and Announces US FDA Emergency Use Authorization for its COVID-19 qPCR Test Kits
Todos Medical Enters Into Direct Exclusive Distribution Agreement With Gnomegen and Announces US FDA Emergency Use Authorization for its COVID-19 qPCR Test Kits.
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[{"type":"text","content":"\n ·       Exclusive Distribution agreement covers North America, Latin America, SE Asia, Europe ·       Validation of Gnomegen qPCR kits now complete at CLIA/CAP-certified lab partner ·       Focus now on commercialization of combination PCR/antibody testing paradigm REHOVOT, Israel, SINGAPORE and NEW YORK, NY, May 11, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Todos Medical Ltd. (OTCQB: TOMDF), a commercial in vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, as well as antibody and PCR tests for COVID-19, today announced that it has entered into an exclusive distribution agreement with Gnomegen LLC (“Gnomegen”) for the distribution of its digital and quantitative polymerase chain reaction (Digital PCR and qPCR) COVID-19 testing kits in North America, Europe, Southeast Asia and Latin America. In addition, the Company announced that Gnomegen’s qPCR test received Emergency Use Authorization (“EUA”) from the US Food & Drug Administration (FDA) diagnostic test for COVID-19 on May 8th, 2020. Further, the Company announced that it has completed validation testing for the Gnomegen qPCR reagents and is now entering preparations to commercially launch the test in the United States through its partner CLIA lab. On April 15, 2020, CMS increased its payment rates for High-Throughput SARS-CoV-2 diagnostic tests that use high-throughput technologies allowing for increased capacity and faster results to $100 per test. A High-Throughput testing lab can process at least 200 specimens per day using “highly-sophisticated equipment that requires specially trained technicians and more more-intensive processes to assure quality,” according to CMS. Todos expects that its CLIA lab partner will be able to process up to 2,000 tests per day with existing equipment, and can ramp up to 7,000 tests per day over the summer of 2020. “Todos Medical has been positioning itself as a distribution partner to testing labs throughout the world, including high-complexity CLIA labs here in the United States, by securing stable access to large quantities of high quality Digital PCR and qPCR reagents, RNA...