Todos Medical Ltd (OTCQB:TOMDF) announced Monday the completion of the instrument validation in its mobile lab division.
The company said its mobile CLIA lab partner Integrated Health has fully validated the analytical performance of its proprietary ANDis 350 RNA auto-extraction machine in combination with its Accurate 96 qPCR machine as part of the COVID-19 RT-PCR laboratory testing validation process being performed in MOTO+PARA’s Mobile High Complexity Lab.
Integrated Health is expected to complete the clinical validation needed to support the commercial launch in mid-November. MOTO+PARA is in talks with several entities and expects to begin accepting contracts in mid-November 2020, Todos said.
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“We have spent the last three months building the mobile labs system in preparation for a commercial launch with a focus on the highest quality, consistent data generation, and overcoming the many technical challenges that presented themselves in the creation of a highly scalable Biosafety Level 3 built mobile lab,” said Eric Canonico, CEO of MOTOPARA Foundation. “We are pleased to have these high levels of analytical performance in the Todos instruments.”
Brandon Albin, managing partner at Integrated Health, added: “We are confident we can commercially launch the COVID-19 qPCR assay using Todos’ testing paradigm and reach a capacity of 1,000 PCR tests per day per mobile unit, in addition to antigen and antibody testing.”
Todos CEO Gerald Commissiong said that having the ability to reduce PCR turnaround times from 3-6 days to potentially as little as 3-6 hours is a “complete game-changer” in terms of speed to diagnosis and reducing time to isolation.
“We will also be offering COVID-19 antigen screening and surveillance testing, as well as antibody testing to our laboratory and delivery of care partners,” he said.
Currently, Todos said that Integrated Health is in the process of testing 30 known positive and 30 known negative samples to receive CLIA certification allowing MOTO+PARA High Complexity Mobile Labs to operate under Integrated Health’s US national mobile CLIA lab license, authorized in all 50 states. The companies expect to reach this milestone in mid-November.
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