Group B Streptococcus

NEW YORK (GenomeWeb) — IntelligentMDx (IMDx) said today that the artus GBS QS-RGQ kit, developed in partnership with Qiagen, has received CE marking for use with Qiagen's QIAsymphony SP/AS and Rotor-Gene Q instruments.

NEW YORK (GenomeWeb News) – Quidel said after the close of the market on Monday that the US Food and Drug Administration has cleared the company's AmpliVue Group B Strep Assay, the second assay to receive FDA clearance to run on the AmpliVue handheld molecular testing platform.

Researchers last week provided a glimpse of the clinical performance of a trio of extraction-free molecular assays currently being developed by clinical diagnostics firm Quidel.

NEW YORK (GenomeWeb News) – Meridian Bioscience said on Monday that its illumigene Group A Streptococcus and illumigene Group B Streptococcus assays have been recategorized by the US Food and Drug Administration as "moderate complexity" tests under the Clinical Laboratory Improv

Meridian Bioscience's Illumigene nucleic acid amplification test for Streptococcus pyogenes, or Group A Streptococcus, has a clinical sensitivity of 99 percent and specificity of 99.6 percent when compared to the diagnostic gold standard of culture and discrepan

Meridian Bioscience said today that its Illumigene molecular diagnostic products accounted for 16 percent of its fiscal first quarter revenues, which increased 13 percent over the same quarter last year.

Canadian molecular diagnostics firm GenePOC has completed technical development of its benchtop, point-of-care molecular diagnostic system and disposable test cartridges, and has commenced clinical feasibility studies of the platform, company executives said this week.

The US Food and Drug Administration has given 510(k) clearance for five additional pathogens for Idaho Technology's FilmArray Respiratory Panel, the company said this week.

Becton Dickinson said this week that the US Food and Drug Administration has cleared its BD Max Group B Streptococcus Assay for detecting GBS DNA in Lim broth cultures.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Becton Dickinson today said that the US Food and Drug Administration has cleared for marketing its BD Max Group B Streptococcus Assay for detection of GBS DNA in Lim Broth cultures.

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A new analysis examines the gender gap among paper authors in the sciences and says it may take decades or more to close.

Researchers have uncovered signals of selection that may enable the Bajau people to free five hundreds of feet deep, Reuters reports.

In Science this week: paternally inherited cis-regulatory structural variants in autism, and more.

A new report outlines issues facing the implementation of personalized medicine in the UK, the Independent reports.