The US Food and Drug Administration (FDA) has granted 510(k) clearance for the commercialisation of Alere's diagnostic analyser 'Alere Reader' and its BinaxNOW Influenza A & B Card 2.
Alere Reader will be initially used with the BinaxNOW Influenza A & B Card 2, which is a reformulated antigen influenza test, and will be later extended to other lateral flow applications and assays.
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The reader is capable of analysing objective results and connectivities that are considered useful for the assessment of several formats of lateral flow immunoassays.
When a test card is inserted, the reader detects, identifies and analyses the completed lateral flow assay, with results shown on a touchscreen.
Results can be linked to the electronic medical records of the patients, back-end information systems, or printed.
Alere Infectious Disease global president Avi Pelossof said: "The Alere BinaxNOW Influenza A & B Card 2 test, with the Alere Reader, improves what is already a leading rapid testing solution for influenza diagnosis in two key ways: by eliminating operator subjectivity and by connecting test results with information management systems.
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By GlobalData“The Alere Reader platform, paired with Alere’s market-leading lateral flow portfolio, will ensure that over time this novel technology will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings."
It is expected that Alere Reader can be used to achieve precise results in a significant timeframe, leading to the rapid administration of treatment.
The reader secured in-vitro diagnostic (IVD) CE Marking in August last year and was later launched in European and Asian markets.
