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September 13, 2022

MagBio’s collection tube secures FDA 510(k) clearance and CE mark

The MagXtract Collection Tube eliminates the risk of creating cyanide gas during cleaning.

The MagBio Genomics MagXTract Collection Tube for Covid-19 testing has received 510(k) clearance from the US Food and Drug Administration (FDA) as well as CE mark approval.

The company is now launching the collection tube in the US for Covid-19 testing and in Europe for both Covid-19 and influenza testing.

The MagXtract Collection Tube has been designed for the collection and processing of viral samples.

It is claimed to be the first FDA 510(K) approved and CE/IVDR certified guanidine-free molecular transport medium.

The sample collection tube has a proprietary molecular transport medium that eliminates the risk of creating cyanide gas during cleaning.

MagBio Genomics stated that the FDA has advised laboratory staff working at Covid-19 sample processing facilities to avoid using sample collection devices that use guanidine.

During transport, the MagXtract Collection Tube directly lyses cells and inactivates pathogens, which eliminates the need for containment use.

The proprietary stabilisation buffer in the tubes also offers RNA sample stability at room temperature for up to eight days, removing the need for cold storage and shipping.

Additionally, the transport medium acts as a lysis buffer and reduces nucleic acid extraction workflow costs.

MagBio Genomics CEO Hyacinth Ntchobo said: “Accurate detection of pathogens by molecular assays depends on proper collection and stabilisation of samples.

“Poor sample stabilisation results in nucleic acid degradation and overgrowth of some micro-organisms, which may lead to patient misdiagnosis.

“The MagXtract Collection Tube addresses these issues by providing cost-effective room temperature sample transportation and nucleic acid stabilisation over prolonged time, providing clinical laboratories with high-quality samples for accurate molecular detection of pathogens.”

The transport medium is also validated for the collection and stabilisation of bacterial and fungal samples for research studies.

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