BioGX launches CE-IVD marked COVID-19

BioGX BV, the European subsidiary of Birmingham, Alabama based BioGX, announced availability of a CE-IVD marked test for simultaneous detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus RNA in a patient sample using the BD MAX System.

The test is offered in BioGX’s trusted, easy to use Sample-Ready format where all required reagents for real-time PCR are lyophilized in a single tube.  BioGX provided tube snaps into a test-specific position on the BD MAX total nucleic acid extraction cartridge enabling Sample-to-Answer molecular testing.  BioGX kits can be shipped anywhere in the world with no refrigeration required.

“We are very pleased with the reliability and performance of this complex respiratory panel.  The simultaneous detection of COVID-19, Flu A, Flu B and RSV during Flu season would help further augment the BD MAX testing capacity by over 50,000 tests per week,” said Shazi Iqbal, Ph.D., CEO of BioGX.

The BioGX multiplex COVID-19, Flu A, Flu B and RSV test is intended for qualitative detection of RNA specific to SARS-CoV-2,  Influenza A, Influenza B, and Respiratory Syncytial Virus A/B that may be present in Pharyngeal and Nasopharyngeal swab collections in transport media and saline, obtained from individuals at risk of respiratory viral infections.

The BD MAX System, commercialized by BD (Becton, Dickinson and Company), is a fully integrated and automated molecular diagnostic platform already in use at thousands of laboratories worldwide.

The BioGX COVID-19, Flu A, Flu B, RSV test is marketed and sold through BioGX BV’s Global Distribution Network as CE-IVD marked for In Vitro Diagnostic Use. The test is not available for sale or use in the U.S.A.  To locate an authorized distributor or request information, contact BioGX at [email protected]. PR NewsWire