Close Menu

Clostridium difficile

Quidel President and CEO Doug Bryant said this week that the company expects to complete clinical trials by the end of the current quarter to support a subsequent application for US regulatory approval of its AmpliVue C.

Quest Diagnostics said this week that the US Food and Drug Administration has granted 510(k) clearance for its Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler.

Roche last week said that it has received US Food and Drug Administration approval of a new pre-analytical instrument that integrates primary tube handling into its Cobas molecular testing platform.

Quidel said this week that it has received the CE mark for its AmpliVue C. difficile assay, making it the first commercially available test using Quidel's non-instrumented format.

Quidel this week provided an update on its budding molecular diagnostics business, noting that it saw "significant progress" in each of its three MDx initiatives.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Meridian Bioscience announced on Tuesday that it its Clostridium difficile assay has been cleared by the US Food and Drug Administration.

Great Basin said this week that it has submitted a 510(k) application to the US Food and Drug Administration for its molecular diagnostic test for Clostridium difficile.

Pages

The Washington Post reports that a Russian Academy of Sciences commission has led to the retraction of hundreds of scientific papers.

The Los Angeles Times' Daily Pilot reports the chief executive of Vantari Genetics has pleaded guilty in a kickback scheme.

News 4 Jax reports that a Florida bill to prevent life and long-term care insurers from using genetic information in their coverage decisions has easily passed one committee.

In Science this week: potentially pathogenic mutations found in hematopoietic stem cells from young healthy donors, and more.