FDA Nod for Alere's Influenza A & B Test - Analyst Blog


Shares of Alere Inc. ( ALR ), a global provider of point-of-care rapid diagnostic and health information solutions, spiked nearly 2.6% yesterday after the U.S. Food and Drug Administration (FDA) approved its i Influenza A & B test.

The molecular test is the first-of-its-kind designed to detect and differentiate between two most common types of flu virus - influenza A and B - in less than 15 minutes. The test uses nasal swab specimens from patients to extract and analyze the DNA or RNA strands for evidence of the viruses.

Alere i Influenza A & B allows rapid influenza diagnosis. It delivers timely and lab-accurate results on a user-friendly platform, thus ensuring appropriate care for patients as early as possible.

The clinical performance of Alere i Influenza A & B was established in a multi-center, prospective study conducted at 8 U.S. trial sites during the 2012-2013 flu season. A total of 585 prospective nasal swab specimens were collected from patients with influenza-like symptoms.

The samples were evaluated with Alere i and compared to viral culture. All specimens that generated discrepant results between the Alere i Influenza A & B test and viral culture were tested using an FDA cleared RT-PCR assay to confirm influenza status of patients.  

Alere i Influenza A & B was launched earlier this year in Europe. Presently, clinical trials to obtain a waiver for the test from the Clinical Laboratory Improvement Amendments (CLIA) have been completed. Going forward, Alere expects to submit a CLIA waiver filing for the influenza test to the FDA in the beginning of fiscal 2014 third quarter.

Influenza is currently estimated to affect 25-50 million people in the U.S. and causes as many as 150,000 hospitalizations per year. The annual death toll has ranged from 3,000 to 49,000. Influenza also poses significant economic burden, which includes medical care expenses and loss of productivity.

By providing an efficient molecular technology, Alere intends to deliver clinically meaningful and actionable results to clinicians - enabling a quicker and appropriate treatment for influenza patients. Rapid diagnosis of influenza can help reduce length of hospital stays, secondary complications and hospital care expenses.

Zacks Rank

Currently, Alere carries a Zacks Rank #4 (Sell). Better-ranked stocks in the medical products industry include Cardica Inc. ( CRDC ), ICU Medical, Inc. ( ICUI ) and NeuroMetrix Inc. ( NURO ). All these stocks carry a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: ALR , NURO , CRDC , ICUI



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