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Alere receives IVD CE Mark for new lateral flow assay analyzer

MDBR Staff Writer Published 11 August 2016

Alere has secured in-vitro diagnostic (IVD) CE marking in Europe for its new diagnostic analyzer, which can be utilized in both point-of-care and laboratory settings.

The analyzer, dubbed Alere Reader, will initially be available for use with Alere BinaxNOW Legionella and Streptococcus pneumoniae antigen cards. This will be followed by other lateral flow applications and assays.

Alere claims that the analyzer will be useful for physicians, lab technicians and other personnel where they insert test cards into it during read time and it detect, identify and analyse completed lateral flow assays.

The results will be displayed on a touchscreen where an immediate linking and storage with patient’s electronic medical records and back-end information system can take place. Further, Alere Reader also makes sure of quality controls being tested with its automated function.

The Alere Reader will be initially launched in Europe, followed by other regions. Additional assays for detecting respiratory and healthcare-related infections will be added to its menu in the coming six to twelve months.

Alere global president of infectious disease Avi Pelossof said: "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.

"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."

Source: Company Press Release