Clostridium difficile

Quidel this week received 510(k) clearance from the US Food and Drug Administration for its AmpliVue C. Difficile assay.

Life Technologies has received CE IVD marking for its Applied Biosystems QuantStudio Dx platform and launched the instrument in Europe.

Quidel this week provided an update on its burgeoning molecular diagnostics pipeline, noting that it hopes to be able to gain US regulatory approval in the next few months for its CE-marked non-instrumented, isothermal amplification-based AmpliVue assay for Clostridium diffic

PrimeraDx said this week that its ICEPlex quantitative multiplex PCR system and accompanying Clostridium difficile detection assay have received CE marking.

Finnish molecular diagnostics firm Abacus Diagnostica, fresh off winning a pair of key US patents covering its DNA testing technologies, plans to seek regulatory approval in the US next year for tests to detect Staphylococcus aureus and methicillin-resistant S.

Scientists from Great Basin Scientific and three university medical schools and hospitals have published research demonstrating that Great Basin's molecular diagnostic test for Clostridium difficile is as sensitive and specific as a competing molecular test based on real

This story has been updated from a previous version to include information about BD's ongoing assay-development partnership with Diagenode.