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BioGX’s influenza A, B and RSV assay gets CE-IVD marking for use on BD MAX system

MDBR Staff Writer Published 10 October 2016

US-based BioGX has obtained CE-IVD marking for its Flu A, Flu B, RSV automated test for use on Becton, Dickinson and Company’s (BD) MAX system.

The automated test  will identify the presence of Flu A, Flu B and RSV RNA present in nasopharyngeal swabs samples collected from individuals at risk of infection.

The assay for the BD automated real-time PCR instrument will be provided in a snap-in-tube format (Sample-Ready).

Sample-Ready format is said to snap into the test-specific position on the MAX RNA/DNA extraction cartridge supplied by BD.

BioGX provides all test-specific real-time PCR components lyophilized in a single tube.

Sample-Ready lyophilized reagent mixes are compatible with different automated sample extraction and qPCR systems.

BioGX CEO Dr Shazi Iqbal said: “In developing the Sample-ReadyTM family of assays, we listened closely to the needs of our customers and crafted these products to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into any laboratory running the BD MAXTM system.

“Additional diagnostic tests using this technology will be available soon to further extend our market reach.”

BioGX said the Flu A, Flu B, RSV assay is not available for sale in the US.

Based in Birmingham of Alabama, BioGX develops molecular products and offers partner-specified formulation and manufacturing services for molecular tests on a platform of a partner’s choice.