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Clostridium difficile

Dec 17, 2012

FDA Approves Quidel's C. difficile Test

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.

Dec 10, 2012

Nanosphere Gets FDA OK for C. Difficile Test

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.

Dec 10, 2012

Genomic Study Details Emergence and Spread of Epidemic C. difficile Lineages Behind Hospital Outbreaks

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.

Nov 29, 2012

Life Technologies Launches QuantStudio Dx in Europe with Quidel C. Diff Assay

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

Oct 25, 2012

Quidel MDx Pipeline Moving Forward as Planned

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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

Sep 13, 2012

PrimeraDx Gets CE Mark for Multiplex MDx System, C. diff Assay

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

Aug 30, 2012

Finland's Abacus Diagnostica Looks to Submit MRSA Blood Culture, C. Diff Tests to FDA Next Year

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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.

Aug 16, 2012

Study Shows Great Basin C. diff Test Sensitive, Specific as Established Real-Time PCR Assay

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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

Aug 09, 2012

BD Diagnostics Execs Update Molecular Pipeline; New Tests for BD MAX and Viper on Horizon

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

Aug 02, 2012

Idaho Tech Preparing for Regulatory Clearance, Launch of Blood Culture ID, GI Panels

NEW YORK (GenomeWeb News) – Idaho Technology today said that it anticipates commercially launching its blood culture ID and gastrointestinal panels by early 2014.

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The Scan

More Troubling Resistance

The Centers for Disease Control and Prevention estimates more people get sick and die from drug-resistant germs than previously thought, the Washington Post reports.

Many Dollar Bills There

According to the Associated Press, three universities and a healthcare institution are sharing a gift of $1 billion.

'Transparency' Rule Proposed

New rules seek to limit the type of scientific and medical research that can be used to guide public health regulations, the New York Times reports.

Nature Papers Present Method for Simulating Hi-C Data, More

In Nature this week: FreeHi-C approach simulates Hi-C data from interacting genome fragments, and more.

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In Clostridium difficile

  1. ChromaCode Debuts Instrument-Agnostic Multiplex Panel for Multi-Drug Resistant Infection Screening

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