Healthcare Industry News:  metabolic disease 

Diagnostics Regulatory

 News Release - August 9, 2016

Alere Achieves IVD CE Mark for its Alere(TM) Reader Lateral Flow Assay Analyzer

WALTHAM, Mass., Aug. 9, 2016 -- (Healthcare Sales & Marketing Network) -- Alere Inc. (ALR), a global leader in rapid diagnostics, today announced it has achieved In-Vitro Diagnostic (IVD) CE marking in Europe for its new Alere™ Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings. The Alere Reader will be initially available for use with the Alere BinaxNOW® Legionella and Streptococcus pneumoniae antigen cards, with other lateral flow applications and assays to follow.

"The Alere Reader improves what is already a leading rapid testing solution for community-acquired pneumonia (CAP) in Europe in two key ways: by eliminating operator subjectivity and by instantaneously connecting BinaxNOW test results with laboratory and hospital information management systems," said Avi Pelossof, Alere Global President of Infectious Disease. "By ensuring the accuracy of test results, no matter who interprets them, the Alere Reader helps support key goals of regulatory and health stakeholders; in addition, by utilizing the Alere Reader at the point-of-care, providers can obtain the most accurate results within an actionable timeframe so they can administer the right treatment quickly. We are committed to populating the Alere Reader with a comprehensive menu of rapid tests so these benefits can be experienced in any setting where expedient and accurate tests are demanded."

With the Alere Reader, physicians, lab technicians and other healthcare personnel insert test cards into the Alere Reader at the read time, which detects, identifies and analyzes the completed lateral flow assay. Results are displayed on an intuitive touch screen, can immediately be linked to patient electronic medical records and back-end information systems, or can be printed. Further, the Alere Reader provides the user additional confidence in the results with an automated function that ensures quality controls have been tested.

The Alere Reader will launch initially in Europe, with other regions to follow. Additional assays for the detection of respiratory and healthcare associated infections will be added to the Alere Reader menu over the next 6-12 months.

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

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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