June 17--Alere Inc.'s stock rose almost 3 percent yesterday after the announcement that the Food and Drug Administration had given the Waltham-based company clearance for a test it has developed to detect and differentiate influenza A and B in less than 15 minutes.
Shares closed at $35.91, up 2.60 percent, after the news about Alere i, which the company describes as the "first and only" molecular test of its kind for influenza A and B, which account for a majority of flu cases each year.
Alere i, which is expected to have a list price of about $85 for medical practitioners, "is more sensitive and more specific than current rapid tests," said Keith Stauffer, vice president of North America regional marketing. "And we're revolutionizing molecular testing, something that historically takes up to an hour."
During the 2012-2013 flu season, 585 nasal swab specimens were collected from patients with flu-like symptoms at eight U.S. sites, evaluated with Alere i and compared to viral cultures. Within minutes, Alere i was able to detect which patients had influenza and which type through molecular testing, which involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections.
William B. Bonello, an analyst at Craig Hallum Capital Group, said Alere i influenza A and B "has the potential to be a pretty exciting test" but must first obtain a waiver from the Clinical Laboratory Improvement Amendments so that the test can be performed in a doctor's office.
Alere should have that waiver in time for next year's flu season, said Mark A. Massaro, an analyst at Canaccord Genuity.
Alere i influenza A and B was launched earlier this year in Europe. Alere i tests for strep A, clostridium difficile, respiratory syncytial virus, chlamydia and gonorrhea are currently in development.
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