Skip to main content
Premium Trial:

Request an Annual Quote

Cepheid Gets CE IVD Mark for C. Difficile Test

NEW YORK (GenomeWeb news) – Cepheid has launched its molecular diagnostic test for Clostridium difficile as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.
The PCR-based test runs on the company’s GeneXpert System, and it detects and identifies common strains of the C. difficile infection, including the virulent Type 027 strain that had been reported in 16 European countries through June.
C. difficile can cause severe gastrointestinal problems and is resistant to most antibiotics. The company said that there are roughly 58,000 detected C. difficile cases in the UK each year, and the number of deaths rose by around 55 percent to 8,500 in England and Wales in 2007.
"C. difficile-infected patients are a source of transmission to other patients, therefore it is important that infected patients are detected as early as possible in order to minimize the impact of the outbreak,” said Richard James, director of the Centre for Healthcare Associated Infections at the University of Nottingham
David Persing, Cepheid’s executive VP and chief medical and technology officer, said in a statement that the ability to test for the 027 strain “will enable tracking of local hospital outbreaks,” which could “be of significant value to infection control professionals in curbing the spread of C. difficile.”

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more