BioGX Launches Four CE-Marked IVD Assays At The European Congress Of Clinical Microbiology And Infectious Diseases (ECCMID)
VIENNA, AUSTRIA, April 24, 2017 /PRNewswire/ — BioGX, a Birmingham Alabama based molecular diagnostics company, announced the launch of four additional CE-IVD infectious disease tests at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), reflecting the inspiring vision of ECCMID: “Managing Infections, Promoting Science”. BioGX has developed an extensive line of multiplex tests for infectious organisms that aid in early diagnosis and proactive management of infections.
“Our CE-marked infectious disease tests empower clinical laboratories to rapidly expand menu on moderate complexity systems such as the BD MAXTM. Just in time for ECCMID, these four tests are a few of many planned for launch on the BD MAXTM and other fully automated platforms”, said Shazi Iqbal, Ph.D., CEO of BioGX.
BioGX infectious disease tests for the BD MAXTM are offered in a “snap-in-tube” format (Sample-ReadyTM). All test-specific real-time PCR components are lyophilized in a single tube. The Sample-ReadyTM tube snaps into the test-specific position on the BD MAXTM DNA extraction cartridges supplied by Becton, Dickinson and Company* (BD).
BioGX’s four new CE-marked IVD tests include:
BioGX Mycoplasma – Ureaplasma – OSR for BD MAX – intended to aid in the diagnosis of genital infection with Mycoplasma or Ureaplasma bacteria by detecting the presence of Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, and Ureaplasma parvum DNA extracted from ThinPrep or universal transport media (UTM) samples.
BioGX Pneumocystis jirovecii – OSR for BD MAX – intended to aid in the diagnosis of Pneumocystis pneumonia infection by detecting the presence of DNA from the fungus Pneumocystis jirovecii extracted from pretreated sputum samples.
BioGX Mycobacterium tuberculosis Complex – OSR for BD MAX – intended to aid in the diagnosis of Mycobacterium tuberculosis bacterial infection by detecting the presence of M. tuberculosis Complex DNA extracted from pretreated sputum and bronchoalveolar lavage (BAL) samples.
BioGX Bordetella Speciation plus Toxin – OSR for BD MAX – intended as an aid in the diagnosis of Bordetella pertussis, Bordetella parapertussis, and Bordetella holmesii bacterial infection using DNA extracted from nasopharyngeal (NP) swabs or nasal wash specimens.
These products are sold by BioGX’s European subsidiary, located in the Netherlands, and are not available for sale in the United States. To learn more or request information visit www.biogx.com
BioGX manufactures molecular diagnostic CE-IVD tests and provides partner-specified formulation and manufacturing services for custom molecular reagent components. Operating in a cGMP compliant environment, BioGX has 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 Sample-Ready™ technology is applied within clinical, food safety, pharma, and water quality analysis industries worldwide. For its achievements in exporting goods and services around the world, BioGX was honored with the 2017 Alabama Governor’s Trade Excellence Award.
*BD and BD MAX trademarks are property of Becton, Dickinson and Company.
To learn more or request information visit www.biogx.com
Ken Gordon – VP, Global Sales & Marketing