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Unprecedented Global Events Lead Diagnostic Providers to Innovative Breakthroughs

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acraft5   Monday, 09/14/20 07:30:33 PM
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Unprecedented Global Events Lead Diagnostic Providers to Innovative Breakthroughs

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week that, "the U.S. Food and Drug Administration (FDA) has added the TODOS 2019-nCoV RT-qPCR Detection Kit to its Notified List under the Emergency Use Authorization program. Todos is required to submit an Emergency Use Authorization application to the FDA within 15 days of submission of the notification.

The Todos test is currently authorized to use only the QuantStudio 12Flex Instrument as a platform to perform the RT-PCR assay. It is estimated that there are more than 1,000 QuantStudio 12Flex Instrument installations in United States. The Company anticipates first shipments of test kits for existing CLIA laboratory clients to begin next week and will be working with those existing clients to complete validations on additional RT-PCR instruments to expand the commercial reach of the Todos test to include additional RT-PCR instruments. The Company currently has access to sufficient raw materials to manufacture approximately 1,000,000 test kits per week and is expanding its warehouse and logistics capabilities to meet an expected surge in demand in the weeks ahead given the testing market's desire for a highly accurate and analytically stable COVID-19 qPCR test. The Todos test instructions for use (IFU) include use of Todos proprietary ANDis 350 extraction system and extraction reagents that ensure consistency in the RNA extraction and purification process prior to RT-PCR analysis for virus detection.

https://www.marketwatch.com/press-release/unprecedented-global-events-lead-diagnostic-providers-to-innovative-breakthroughs-2020-09-14?mod=mw_quote_news

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