Currently, 3D BioMed is in talks with the US FDA for the test approval in the US. Credit: Fusion Medical Animation / Unsplash.

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Vitro-diagnostics company Todos Medical has signed a non-exclusive agreement with China-based cancer precision medicine company 3D Biomedicine Science & Technology for the distribution of the latter’s coronavirus test kits in the US and Israel.

According to the agreement, Todos will distribute 3D BioMed’s 3DMed 2019-nCoV Detection Kit (COVID), 3DMed 2019-nCoV & Flu A/B Detection Kit (COVID/Flu) and its ANDiS 350 3DMed Automated Solution countertop real-time PCR machine (3D Machine).

The kits have obtained approval from the Chinese Food and Drug Administration (FDA) and also secured a CE Mark in Europe.

Currently, the company is in talks with the FDA with regards to the approval of its products in the US.

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Todos chief medical advisor Jorge Leon said: “The main differentiation in the 3D BioMed offering versus other nucleic acid PCR-based testing is the influenza A and B tests combined with coronavirus testing.

“This is a clinically meaningful combination because of the extended flu season in the United States that will create additional doubt among healthcare providers regarding the cause of symptoms for patients. The fact that this will be available in one testing paradigm seems to be novel in the United States.”

3D BioMed’s technology was initially deployed in Wuhan, China, where it has been used for more than 100,000 tests.

In Chinese clinical trial, the test has demonstrated 99.3% sensitivity and 100% specificity.

The company has shipped its kit components to the Provista Diagnostics lab in Georgia.

As part of the agreement, Todos will use the lab to conduct the CLIA validation required to launch the test in the US.

Meanwhile, the US has reported more than 6,000 coronavirus cases with the death toll reaching over 100. The disease has been confirmed in all US states.