WALTHAM Mass., March 18, 2016 /PRNewswire/ -- Alere Inc. (NYSE: ALR), a global leader in rapid diagnostic tests, today issued the following statement today regarding its anticoagulation monitoring technology:
Alere is committed to developing and manufacturing safe and effective anticoagulation monitoring technology to help patients and to better inform medical decision-making. The types of issues in INR measurements that could lead to serious adverse events are rare. In the case of the ROCKET-AF study, multiple recently published analyses have found no significant difference in serious adverse events between patients who used the Alere INRatio device and those who did not:
- New England Journal of Medicine at http://www.nejm.org/doi/full/10.1056/NEJMc1515842?rss=searchAndBrowse&), and
- European Medicines Agency at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000944/WC500201726.pdf
Alere will continue to identify factors contributing to such issues, no matter how rare, and take appropriate measures to further mitigate them. Alere continues to communicate the progress of these efforts with clinicians and regulators with the ultimate intent of providing better product and service to clinicians and their patients on anticoagulation therapy.
About Alere Alere believes that when diagnosing and monitoring health conditions, Knowing now matters™. Alere delivers reliable and actionable information through rapid diagnostic tests, resulting in better clinical and economic healthcare outcomes globally. Headquartered in Waltham, Mass., Alere focuses on rapid diagnostics for infectious disease, cardiometabolic disease and toxicology. For more information on Alere, please visit www.alere.com.
SOURCE Alere Inc.