BioGX launches CE-IVD Marked COVID-19, Influenza A/B, RSV Combo RT-PCR Test for the BD MAX™ System

AMSTERDAM, Sept. 29, 2020 /PRNewswire/ -- 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 info@biogx.com.

About BioGX B.V.

BioGX B.V., based in Amsterdam, The Netherlands is a provider of molecular diagnostics reagents for infectious disease testing. It is a wholly owned subsidiary of BioGX, with corporate headquarters located in Birmingham, Alabama.

About BioGX

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics.  BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively "BioGX"), operates in a cGMP compliant environment certified to International Standard ISO 13485. The company applies its proprietary Sample-Ready^™ lyophilized technology to offer products and contract services across a variety of real-time PCR platforms. The Sample-Ready^™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing.  BioGX B.V.'s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network.

For more information on BioGX, please visit BioGX.com.

*BD and BD MAX trademarks are property of BD (Becton, Dickinson and Company).
Sample-Ready and Just Add Water are registered trademarks of BioGX, Inc.

Contact Information:
Robyn Martin-Schubart.
Marketing Communications
+31.20.893.4261
EU@biogx.com

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