Todos Medical Ltd (OTCQB:TOMDF) announced Friday that the US Food and Drug Administration has added the company’s COVID-19 qPCR detection test kit to its Notified List under the Emergency Use Authorization (EUA) program.
The FDA’s decision allows the Israeli company to commercially launch its branded test kits in the US. Todos is required to submit an EUA application to the FDA within 15 days of submission of the notification.
Todos said its 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 the US.
READ: Todos Medical doubles August sales to around $1.2M on the back of surging demand for extraction reagents and equipment
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.
Todos said it currently has access to sufficient raw materials to manufacture approximately one million 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 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.
“We are excited to make our highly sensitive RT-PCR test kits available in the United States as we continue to see spikes in COVID diagnoses in multiple areas,” said Todos CEO Gerald Commissiong in a statement.
“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.“
He added: “Our goal is to be a one-stop solution for all COVID testing including PCR tests, antigen tests, antibody tests and our proprietary 3C protease rapid test, as Todos begins to play a more prominent role in addressing the global COVID-19 crisis.”
Meanwhile, with the validation of Todos branded COVID-19 test kits now complete and submissions to FDA ongoing, the company is currently advancing its proprietary COVID + flu A/B test and intends to submit it to the FDA.
“Todos is positioning itself as a science-focused leader in the COVID-19 space that will stay at the forefront of the science and medical need in order to provide intelligent solutions that address the key challenges emerging worldwide,” Commissiong said.
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