Abbott announced the availability of two new CE Marked molecular diagnostic tests for the rapid and accurate detection of the bacterial causes of common but serious infections striking patients in health care facilities – Clostridium difficile (C. diff) and vancomycin-resistant enterococci (VRE). The IMDx™ C. difficile for Abbott m2000™ and IMDx VanR for Abbott m2000 tests are performed on Abbott’s m2000 automated molecular diagnostics system. These products are not available for sale in the United States.

Molecular diagnostic tests are becoming important in clinical laboratories because of their rapid turnaround time and accuracy in detecting pathogens responsible for human diseases. Rapid detection can enable hospital personnel to isolate infected patients in a timely manner.

“We are addressing a major unmet need in health care with the early identification of C. diff and VRE bacteria, both of which can significantly prolong a patient’s hospital stay and increase costs,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business.

Abbott’s collaboration with IMDx further expands the assay menu of the m2000 system and enables laboratories to rely on one automated molecular testing system for a wide range of infectious disease tests.

The IMDx C. diff and VanR tests are the first to be distributed by Abbott Molecular under a multi-year agreement with Intelligent Medical Devices, Inc, (IMDx) of Cambridge, Massachusetts. As part of the agreement, Abbott will introduce several additional IMDx-developed assays for the m2000 system, including tests for the identification of Group B Streptococci, Influenza A/Influenza B, Respiratory Syncytial Virus, Herpes Simplex Virus 1 and 2, Epstein-Barr virus and BK Virus.

About C. diff and VRE

C. difficile as the causative agent of antibiotic-associated diarrhea, pseudomembranous colitis, and toxic megacolon, is a major cause of healthcare-associated infection. In antibiotic-associated diarrhea, antiboiotic usage leads to disruption of the normal intestinal flora, leading to colonization by C. difficile if the patient is exposed to a carrier of C. difficile. The IMDx C. difficile for Abbott m2000 assay detects toxigeneic C. difficile toxin A and B genes in specimens from patients with symptoms of C. difficile-associated disease and is intended for use as an aid in the diagnosis of C. difficile.