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Alere's (ALR) Influenza Test Gets CLIA Waiver from the FDA - Analyst Blog

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Global rapid diagnostic tests company, Alere Inc. (ALR), has received a waiver from the U.S. Food and Drug Administration (FDA) which makes way for the company’s i Influenza A & B test to be used in a greater variety of health care settings. The Alere i Influenza A & B is a molecular test designed to allow rapid influenza diagnosis.

Alere’s Influenza test was earlier available only for use in certain laboratories. As the FDA waiver has been granted under the Clinical Laboratory Improvement Amendments (CLIA), the Alere i Influenza A & B test can now be used across a wide variety of clinical settings, including doctors' chambers, emergency rooms, clinics and other healthcare facilities.

The FDA had first approved the test in June as a prescription-only device, categorizing it as moderately complex and therefore not to be used widely. However, the regulatory body allowed a wider use of the test after the company submitted data demonstrating its ease of use and low risk of false results when used by untrained operators.

Influenza affects millions of people in the U.S. each year. According to the Centers for Disease Control and Prevention, more than 200,000 people in the U.S. are hospitalized for seasonal flu-related complications annually. As per a Reuters report, the current flu season has already recorded 21 deaths so far.

Additionally, influenza poses significant economic burden, which includes medical care expenses and loss of productivity. Thus, rapid diagnosis of the disease can help reduce length of hospital stays, secondary complications and hospital care expenses.

The Alere i Influenza A & B test delivers timely and lab-accurate results on a user-friendly platform. The test uses a nasal swab sample of the patient with signs and symptoms of flu infection and provides results in as little as 15 minutes.

By providing an efficient molecular technology, this Waltham, MA-based company intends to deliver clinically meaningful and actionable results to clinicians – enabling a quicker and appropriate treatment for influenza patients.

Alongside its effort to improve influenza treatment, Alere is also taking steps to advance HIV screening and diagnosis. Notably, Alere’s HIV Combo Test was granted a CLIA waiver by the FDA last month. With the CLIA waiver, Alere’s HIV test is now available for broader use in HIV screening, facilitating accurate and early detection.

However, competition for rapid diagnostic testing products is intense and is primarily based on price, quality, breadth of product line, technology and distribution capabilities. As such, Alere counters significant competition from large diagnostic companies like Becton, Dickinson (BDX), Abbott Laboratories (ABT) and Johnson & Johnson (JNJ) among others.

Currently, Alere carries a Zacks Rank #3 (Hold).


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