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BioGX launches six CE-Mark tests for meningitis and antibiotic resistance

Published 25 May 2018

BioGX has launched six additional CE-Mark infectious disease tests on Becton, Dickinson and Company's BD MAX Sample-to-Answer platform.

This brings the company's CE-Mark menu for the BD MAX™ to eleven tests, with an additional ten planned for the second half of 2018.  

BioGX CEO Dr Shazi Iqbal said: "With the availability of eleven CE-Mark tests, BioGX B.V. continues its leadership position in developing and manufacturing tests for the BD MAX™ platform.  Expect no less from us for the next generation of Sample-to-Answer open platforms.”

According to BioGX's Executive Vice President and CSO, Michael Vickery, Ph.D., "BioGX is uniquely equipped to keep pace with changing clinical needs in a world of new emerging pathogens, ever increasing identification of new molecular diagnostic targets, and improved detection technology.  Our platform agnostic Sample-Ready™ lyophilized reagents, lean and scalable manufacturing, talented scientific team with a decade of Sample-to-Answer product development expertise, and exceptional customer partnerships, enable us to rapidly expand menu of multiplex assays for use on virtually any platform."

The six new CE-Mark Meningitis and Antibiotic Resistance tests on BD MAX™ are:

Viral Meningitis HSV/VZV - Aids in diagnosis of viral meningitis infection by detecting the presence of DNA from HSV-1, HSV-2, and VZV.

Bacterial Meningitis NSH - Aids in diagnosis of bacterial meningitis infection by detecting the presence of DNA from Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae.

Bacterial Meningitis ELGBS - Aids in the diagnosis of bacterial meningitis infection by detecting the presence of DNA from Escherichia coli, Listeria spp., and Group B Streptococcus.

Carbapenem Resistance KNO - Aids in detection of carbapenem resistant Enterobacteriaceae and other organisms resistant to carbapenem harboring DNA from resistance genes KPC, NDM-1, and OXA-48.

Carbapenem/Colistin Resistance VGM - Aids in detection of carbapenem and/or colistin resistant Enterobacteriaceae and other organisms resistant to carbapenem and/or colistin harboring DNA from resistance genes VIM, GES, and mcr-1.

Vancomycin Resistance - Aids in detection of vancomycin resistant Enterococcus and other organisms resistant to vancomycin harboring DNA from resistance genes vanA, vanB, vanC1, and vanC2/3.

BioGX B.V.'s CE-Mark products are marketed and sold exclusively by BioGX B.V. or its authorized distributors and are not available for sale in the United States. 

Source: Company Press Release