Israel-based in vitro diagnostics company Todos Medical has announced the commercial launch of its TODOS 2019-nCoV RT-qPCR Detection Kit in the US.
The US Food and Drug Administration (FDA) has added the kit to its Notified List under the emergency use authorisation (EUA) programme. Todos is required to submit a EUA application to the agency within 15 days of submission of the notification.
The Todos test includes the company’s proprietary ANDis 350 extraction system and extraction reagents that ensure consistency in the RNA extraction and purification process before the RT-PCR analysis for virus detection.
Currently, the test is authorised for use in the QuantStudio 12Flex platform to perform the RT-PCR assay. It is estimated that there are over 1,000 QuantStudio 12Flex Instrument installations in the US.
The company expects to offer first shipments of test kits for its current CLIA laboratory clients next week.
It also plans to collaborate with existing clients to complete validations on additional RT-PCR instruments in order to include additional RT-PCR instruments for the test.
Todos Medical president and CEO Gerald Commissiong said: “We are excited to make our highly sensitive RT-PCR test kits available in the US as we continue to see spikes in Covid-19 diagnoses in multiple areas.
“We have taken a thoughtful and measured approach to address 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.”
Todos currently has access to sufficient raw materials to produce approximately 1,000,000 test kits each week.
The company is also expanding its warehouse and logistics abilities to cater to a potential surge in demand in the coming weeks.
In July, Todos expanded its agreement with 3D Medicines, obtaining the exclusive right to seek out US FDA EUA for 3D Med’s SARS-CoV-19.