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Alere Reader platform FDA cleared

April 27, 2017Alere announced the introduction of its Alere Reader, an FDA 510(k)-cleared diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a variety of lateral flow immunoassay formats. The Alere Reader, which can be used in point-of-care and laboratory settings, will be initially available for use with the BinaxNow Influenza A & B Card 2, with other lateral flow applications and assays to follow. This reformulated test card is the first rapid antigen influenza test to achieve 510(k) clearance as a class II assay under the new FDA reclassification requirements, according to the company.

With the intent to expand the settings in which the platform can be used, Alere plans to submit an application for CLIA waiver of the Alere BinaxNow Influenza A & B Card 2 test for use on the Alere Reader.

“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,” Avi Pelossof, Alere global president of infectious disease, said in a statement. “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.”

With the Alere Reader, users insert test cards into the platform, which detects, identifies, and analyzes the completed lateral flow assay. Results are displayed on an intuitive touchscreen, can immediately be linked to patient electronic medical records and back-end information systems, or can be printed.

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