Skip to main content
Premium Trial:

Request an Annual Quote

Dx Focus: FDA OKs IntelligentMDx C. Difficile Abbott m2000 Assay

Premium

IntelligentMDx said today that it has received US Food and Drug Administration clearance for its IMDx C. difficile for Abbott m2000 assay, a test that detects nucleic acids encoding the toxin A gene and toxin B gene sequences of toxigenic strains of Clostridium difficile in human stool specimens.

IMDx's analytical reactivity studies have demonstrated that its C. difficile assay is capable of detecting 31 different strains representing the global diversity of C. difficile, including NAP1 and tcdB variants.

C. difficile is the leading cause of hospital-acquired diarrhea and is linked to approximately 14,000 deaths in the United States annually, the company said.

IMDx's C. difficile assay is the company's third to receive FDA clearance in the last three months for use on Abbott's fully-automated m2000 system— following the IMDx VanR for Abbott m2000 and IMDx Flu A/B and RSV for Abbott m2000 assays (PCR 9/12/2013)

IMDx has a multi-year distribution agreement with Abbott encompassing a broad real-time PCR test menu designed, developed and manufactured for use on the m2000 system (PCR 3/17/2011).

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