BioGX Receives CE Mark For Influenza, RSV Assay
News Oct 07, 2016
BioGX has announced that it has received CE-IVD marking for its Flu A, Flu B, RSV automated test on Becton, Dickinson and Company’s (BD) BD MAXTM system for detection of Influenza A, B and Respiratory Syncytial Virus (RSV). The test is intended to simultaneously detect the presence of Flu A, Flu B and RSV RNA present in nasopharyngeal swabs samples collected from individuals at risk of infection.
The Flu A, Flu B, RSV assay for the BD MAXTM automated real-time PCR instrument is offered in a “snap-in-tube” format (Sample-ReadyTM). BioGX provides all test-specific real-time PCR components lyophilized in a single tube. The Sample-ReadyTM tube snaps into the test-specific position on the BD MAXTM RNA/DNA extraction cartridge supplied by BD.
BioGX Sample-ReadyTM assays empower clinical laboratories with the time- and cost-savings of moderate complexity systems such as minimum assay manipulation, simple workflow, and quick turnaround times. Sample-ReadyTM lyophilized reagent mixes are designed to be compatible with a variety of automated sample extraction and qPCR systems. BioGX reagent technology affords the flexibility to run automated tests as singles or in batches to fit the needs of a laboratory workflow.
“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" said Shazi Iqbal, Ph.D., CEO of BioGX. The Flu A, Flu B, RSV assay for BD MAXTM is sold directly by BioGX and it is not available for sale in the United States at this time.