Healthcare Industry News:  BD  

Diagnostics Regulatory Product Launch

 News Release - October 23, 2018

BioGX Launches 5 new CE Mark IVD Tests, Expands Sexual Health Panels on the BD MAX(TM)

AMSTERDAM, Oct. 23, 2018 -- (Healthcare Sales & Marketing Network) -- BioGX B.V., recently released five (5) new sexual health CE Mark IVD products on the BD MAXTM automated sample-to-result platform, making the BD MAXTM one of the most comprehensive sexual health sample-to-result molecular platforms on the market. Adding to BioGX B.V.'s existing sexual health offering, the BioGX multiplex Mycoplasma-Ureaplasma test, are the following new tests:
  • Candida Speciation GATPK - Aids in the diagnosis of Candida infection by detecting the presence of DNA from the species that represent approximately 95% of human Candida infections: Candida glabrata, C. albicans, C. tropicalis, C. parapsilosis, and C. krusei.
  • Candida-Trichomonas - Aids in the diagnosis of Candida and Trichomonas infection by detecting the presence of DNA from Candida glabrata, C. albicans, C. krusei, and Trichomonas vaginalis.
  • Lesion HSV - Aids in diagnosis of genital lesions by detecting the presence of DNA from HSV-1 and HSV-2.
  • Lesion HSVHD - Aids in diagnosis of genital lesions by detecting the presence of DNA from HSV-1, HSV-2, and Haemophilus ducreyi.
  • Urinary Tract EKEGAS - Aids in diagnosis of urinary tract infections by detecting the presence of DNA from E. coli, Klebsiella spp., Enterococcus faecalis, and Group A Streptococcus.
According to BioGX's Vice President of Global Sales & Marketing, Ken Gordon, "Our sexual health products represent our commitment to supporting improved patient outcomes in an extremely important testing area. Laboratorians and clinicians now have more options for syndromic group menu expansion on their BD MAXTM platforms."


BioGX will continue the expansion of its sexual health offerings in the coming months, including the release of a Syphilis panel (Treponema pallidum), which is anticipated in December 2018.

BioGX's CE Mark IVD products are marketed and sold exclusively by BioGX B.V. or its authorized distributors and are not available for sale in the United States. To contact BioGX B.V. or request additional information, please visit www.biogx.com/eu.

About BioGX B.V.

BioGX B.V., based in Amsterdam, The Netherlands, is a provider of molecular diagnostics reagents across diverse clinical applications. It is a wholly owned subsidiary of BioGX, headquartered in Birmingham, AL.

About BioGX

BioGX provides partner-specified formulation and manufacturing services for custom molecular reagent components. Operating in a cGMP compliant environment, BioGX has over a decade of experience in applying its proprietary platform-agnostic reagent technology across a variety of real-time PCR and Next Generation Sequencing platforms. The company's proprietary Sample-Ready™ technology is applied within clinical, food safety, pharma, and water quality analysis industries worldwide.

*BD MAX is a registered trademark of Becton, Dickinson and Company. *Sample-Ready is a registered trademark of BioGX, Inc.


Source: BioGX

Issuer of this News Release is solely responsible for its content.
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