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October 9, 2016

BioGX obtains CE-IVD marking for influenza A, B and RSV assay on BD MAX System

US-based BioGX has secured CE-IVD marking for its Flu A, Flu B, RSV automated test on Becton, Dickinson and Company's (BD) MAX system to detect influenza A, B and Respiratory Syncytial Virus (RSV).

US-based BioGX has secured CE-IVD marking for its Flu A, Flu B, RSV automated test on Becton, Dickinson and Company's (BD) MAX system to detect influenza A, B and Respiratory Syncytial Virus (RSV).

The objective of the test is to simultaneously identify the presence of Flu A, Flu B and RSV RNA in nasopharyngeal swab samples collected from individuals at risk of infection.

The Flu A, Flu B, RSV assay for the BD MA automated real-time PCR instrument is provided in a snap-in-tube format, called Sample-Ready.

"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 MAX system."

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

This Sample-Ready tube snaps into the test-specific position on the BD MAX RNA/DNA extraction cartridge, which is supplied by BD.  

BioGX Sample-Ready assays offer clinical laboratories with the time and cost-savings unlike other complex systems. It enables minimum assay manipulation, simple workflow, and quick turnaround times.

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

 BioGX reagent technology offers the flexibility to run automated tests as singles or in batches to fit the requirements of a laboratory workflow.

BioGX CEO Shazi Iqbal said: "In developing the Sample-Ready 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 MAX system.

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

Currently, the Flu A, Flu B, RSV assay for BD MAX is sold directly by BioGX and not available for sale in the US.

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