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Clostridium difficile

NEW YORK (GenomeWeb News) – IntelligentMDx today said that the US Food and Drug Administration has cleared its C. difficile assay for the Abbott m2000 system.

NEW YORK (GenomeWeb News) – Exposure to symptomatic individuals within healthcare settings may account for just a fraction of Clostridium difficile infections, according to a study from the UK appearing online last night in the New England Journal of Medicine.

NEW YORK (GenomeWeb News) – Microbioal genetic analysis firm OpGen today announced it has received Clinical Laboratory Improvement Amendments certification.

A new automated molecular diagnostic assay to detect toxigenic Clostridium difficile directly from stool samples was found to have comparable sensitivity and specificity to both the gold standard of culture-based testing and reference testing with a competing assay, Ceph

PrimeraDx, a Mansfield, Mass.-based molecular diagnostics firm, is on track to submit its highly multiplexed PCR-based testing system and associated assay for Clostridium difficile to the US Food and Drug Administration this quarter, CEO Matt McManus said recently.

NEW YORK (GenomeWeb News) – Becton Dickinson's BD Diagnostics segment today said that its BD Max Cdiff Assay has been cleared by the US Food and Drug Administration for marketing in the US.

Life Technologies and Quidel said this week that they have received 510(k) clearances from the US Food and Drug Administration to market the Quidel Molecular Direct C.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared the Quidel Molecular Direct C.

Health management services and diagnostics firm Alere recently updated investors on the progress of a pair of nucleic acid testing platforms that are currently under development at the company and represent the firm's entrée into molecular diagnostics.

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.

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Reuters reports that Germany is seeking to sequence 5 percent of patient samples that test positive for SARS-CoV-2.

23andMe and Medscape say primary care physicians are increasingly more comfortable with discussing direct-to-consumer genetic testing results.

The publisher of the Science family of journals will allow some authors to place peer-reviewed versions of their papers into publicly accessible repositories.

In Science this week: analysis of genome-wide association studies of chronic kidney disease, and more.