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Clostridium difficile

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

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Quidel's molecular diagnostic assay for detecting Clostridium difficile infections for sale in the US, the San Diego-based company said today.

NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has granted 510(k) clearance for the firm's Clostridium difficile molecular test.

NEW YORK (GenomeWeb News) – Not one but two epidemic Clostridium difficile lineages that emerged in North America are behind hospital outbreaks at centers around the world since 2001, according to a new Nature Genetics study by a Wellcome Trust Sanger Institute-led team.

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.

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The editorial board of the Pittsburgh Post-Gazette says other lawmakers should take Florida's approach and provide additional protections against genetic discrimination.

The Hill reports 17 states and the District of Columbia are suing over a new policy that would strip international students of their visas if they only attend classes online.

Centers for Disease Control and Prevention employees call on the agency to label racism a public health crisis and examine its own policies, NPR reports.

In PNAS this week: genetic evidence for Inca resettlement, analysis of spermatogonial stem cell transcriptomes, and more.