Alere's Flu Test Gains FDA Waiver - Analyst Blog


Alere ( ALR ), a medical products company focused on integrating rapid diagnostics with health management, recently revealed that it has received a confirmation that the U.S. Food and Drug Administration ("FDA") had cleared the Alere Influenza A&B Test for the domestic market.  

The test has been classified by the Clinical Laboratory Improvement Amendments (CLIA), the U.S. regulatory standards for all human clinical laboratory testing, as "waived test."

Alere's new offering is a very sensitive rapid test designed for use in the doctor's chamber. It is expected to assist medical practitioners take better care of patients with influenza-type diseases.   

The Alere Influenza test received its waived status following numerous studies to validate the test and after substantial collaboration with the FDA. Alere believes that by introducing this product in the waived segment of the market place, it is providing medical practitioners with a new tool in the fight against flu.

The Alere Influenza A&B Test utilizes exceedingly sensitive antibodies to find influenza types A and B antigen. This test requires a nasal swab and sample collection is less invasive. This test gives results in just 10 minutes, which permits doctors to rapidly administer treatment to their patients.  

Diagnostic tests are shifting closer to the consumers and into the home testing market, as more diagnostic tests are being developed to monitor patients rather than simply diagnose them. Alere's strategy of combining disease management with point-of-care testing ("POCT"), in a manner that encourages patients to take responsibility over their overall health care, is viewed as a prudent approach while at the same time ensuring affordability.

In addition to growing its revenues through a combination strategy of continued acquisitions and measured organic growth, the company is committed to improving its operating margin. Further, its product pipeline is strong, which has been developed through a combination of internal R&D as well as serial acquisitions. One of the company's competitors is Abaxis ( ABAX ).

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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: ABAX , ALR

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