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Abbott Announces Availability of Two New CE-Marked Molecular Assays for its m2000 System to Detect Infections Spread in Healthcare Settings


*Tests Provide Rapid Detection of C. difficile and Vancomycin-resistant enterococci

Wiesbaden, Germany — Abbott (NYSE: ABT) 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.

Enterococci are normally found in the intestine and the female genital tract and sometimes can cause infections of the urinary tract, blood stream, or in wounds from surgery or catheter insertions. Enterococci easily acquire antibiotic resistance and are intrinsically resistant to many antibiotics. Enterococcal infections are a common cause of hosptial-acquired infections and typically occur in the very ill and debilitated patients that have been exposed to broad spectrum antibiotics. The IMDx VanR for Abbott m2000 assay detects the presence of vanA and vanB genes that can be associated with VRE. The test is intended for use on samples from patients at risk of VRE colonization.

About the Abbott m2000 System

Abbott’s automated molecular diagnostics system, the m2000, utilizes real-time polymerase chain reaction (PCR) technology for detecting and monitoring infectious diseases and is designed to provide clinical laboratories a unique system that fully automates all of the complex and heavily manual steps often associated with molecular diagnostics.

Abbott currently markets the m2000 system, which achieved a milestone earlier this year with its 1,000th global placement, and a menu of infectious disease assays in countries throughout the world. With the addition of these two new assays, the m2000 system offers 13 assays outside the U.S., the largest menu on a major automated system.

About Abbott Molecular

Abbott Molecular is a leader in molecular diagnostics — the analysis of DNA, RNA, and proteins at the molecular level. Abbott Molecular’s tests can also detect subtle but key changes in patients’ genes and chromosomes and have the potential for earlier detection or diagnosis, provide information relevant to the selection of appropriate therapies, and may improve monitoring of disease progression.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.


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