The Todos test has been authorised to use only the QuantStudio 12Flex Instrument as a platform to conduct the RT-PCR assay
In-vitro diagnostics company Todos Medical has announced the commercial launch of Todos 2019-nCoV RT-qPCR Detection Kit in the US.
The Todos 2019-nCoV RT-qPCR Detection Kit has been notified under the emergency use authorisation (EUA) programme.
The company has to submit an EUA application to the FDA within 15 days of submission of the notification.
At present, the Todos test is authorised to use only the QuantStudio 12Flex instrument as a platform to conduct the RT-PCR assay.
According to the company, more than 1,000 QuantStudio 12Flex instruments are expected to be operational across the US.
Todos Medical intends to make the first shipments of test kits for existing CLIA laboratory clients in the next week
The company plans to make first shipments of test kits for existing CLIA laboratory clients in the next week and will work them to complete validations on additional RT-PCR instruments to expand the commercial reach of the Todos test to include additional RT-PCR instruments.
The Todos test instructions for use (IFU) comprise the application of Todos And is 350 extraction system and extraction reagents that help to maintain consistency in the RNA extraction and purification process prior to RT-PCR analysis for virus detection.
Todos Medical president and CEO Gerald Commissiong said: “We have taken a thoughtful and measured approach to addressing our nation’s COVID-19 testing bottlenecks, including a shortage of equipment, personnel and reagents, and will now begin to work on reducing lengthy turnaround times for results that often leads to questionable accuracy by focusing on our mobile lab initiatives.
“These initiatives have been making great strides in the last several weeks and will serve as a new distribution channel for our products.”
In January this year, Todos Medical agreed to acquire in vitro diagnostics company Provista Diagnostics for an undisclosed sum.