BioGX Receives CE-IVD Mark For Enhanced Flu Assay
Amsterdam, The Netherlands, 22 October 2019 – BioGX B.V., the European subsidiary of Birmingham, Alabama based BioGX, announced it has received CE-IVD marking for its new Flu A, Flu B, RSV A/B automated test. The new test significantly enhances the strain coverage and detection sensitivity, and offers testing for a greater variety of specimen types compared to the initially released test. BioGX will work with distributors and customers to gradually transition current Flu test users to the new test. Just like the test it is replacing, the new test is a multiplex real-time RT-PCR assay for use on the BD MAX(TM) system, made by BD (Becton, Dickinson and Company).
The new Flu test is intended for qualitative detection of RNA specific to Influenza A, Influenza B, Respiratory Syncytial Virus A and Respiratory Syncytial Virus B that may be present in Nasal wash, Pharyngeal swab and Nasopharyngeal swab collections obtained from individuals at risk of respiratory viral infections.
“The launch of an enhanced Flu test is a testament to our team’s ability to listen and address customers’ needs with speed. Customers asked for a Flu test with broader coverage of specimen types without compromising sensitivity, and our team delivered,” said Shazi Iqbal, Ph.D., CEO of BioGX.
As with all BioGX tests, this test is offered in BioGX’s proprietary Sample-Ready™ format in which all real-time PCR reagents are lyophilized in a single tube that snaps into a test-specific position on the BD MAX™ exK TNA extraction cartridge, which is supplied by BD. The launch of this important clinical tool represents the 23rd BioGX CE-IVD test made available for BD MAX™ in less than 2 years.
The Flu A, Flu B, RSV A/B assay – OSR for BD MAX™ is marketed and sold through BioGX B.V.’s Global Distribution Network and is not available for sale in the United States. To locate an authorized distributor or request information, visit: www.biogx.com/eu.
About BioGX B.V.
BioGX B.V., based in Amsterdam, The Netherlands and certified to International Standard ISO 13485, is a provider of molecular diagnostics reagents across diverse clinical applications. It is a wholly owned subsidiary of BioGX, with corporate headquarters located in Birmingham, Alabama.
BioGX, based in Birmingham, Alabama, operates in a cGMP compliant environment certified to International Standard ISO 13485. BioGX develops molecular products and provides partner-specified formulation and manufacturing services for molecular tests on a platform of a partner’s choice. The company applies its proprietary platform-agnostic reagent technology to offer products and contract services across a variety of real-time PCR and Next Generation Sequencing platforms. The Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality testing. BioGX products are available worldwide through direct sales and their Global Distribution Network.
*BD and BD MAX trademarks are property of BD (Becton, Dickinson and Company).
*Sample-Ready is a registered trademark of BioGX, Inc.