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Alere Achieves FDA Clearance for Alere™ Reader Platform and Alere BinaxNOW® Influenza A & B Card 2

Alere Inc., a global leader in rapid diagnostics, announced that its Alere™ Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510(k) marketing clearance from the US Food and Drug Administration (FDA). The Alere Reader 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.                  

This announcement represents the introduction into the US market of the Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a wide variety of lateral flow immunoassay formats. This follows a successful release of the Alere Reader into Europe and select Asian markets since In-Vitro Diagnostic (IVD) CE marking in August 2016.

With the intent to expand the settings in which this platform can be deployed, Alere expects to promptly submit an application for CLIA (Clinical Laboratory Improvement Amendments) 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," said Avi Pelossof, Alere Global President of Infectious Disease. "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."

The Alere Reader helps support key goals of healthcare and regulatory stakeholders by ensuring the accuracy and reproducibility of test results. By utilizing the Alere Reader at the point-of-care, providers can obtain highly accurate results within an actionable timeframe and then administer the appropriate treatment quickly. In addition to the Alere Reader, Alere's extensive flu portfolio includes: Alere™ i Influenza A & B, the first-ever CLIA-waived molecular flu test, and the Alere™ Influenza A & B dipstick test.

With the Alere Reader, physicians, lab technicians and other healthcare personnel insert test cards into the platform, 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.

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