The FDA greenlighted Alere's rapid influenza diagnostic test, which detects influenza A and B infection in adults and children in as few as five minutes.
The Alere i Influenza A & B 2 test is a second-generation rapid molecular assay that uses samples directly from a swab or in a transport medium, Alere said in a statement. The company plans to apply for a CLIA waiver for the test.
The Alere i platform was first cleared for the detection of the influenza A and B viruses in 2014. The company added tests for strep A and RSV to the platform in 2015 and 2016, respectively. Alere will roll out the new flu test to hospitals "in time for the 2017-2018 respiratory season," according to the statement.
"Our innovative Alere i platform leads the way in the rapid molecular segment with thousands of placements in hospitals, clinics, physician offices and other point of care settings. With this latest enhancement we now can offer 'early call out' of positive results on all three available applications, Alere i Influenza A & B 2, Alere i Strep A and Alere i RSV," said Avi Pelossof, Alere's global president of infectious disease, in the statement. "In acute care settings, every minute counts when assessing symptomatic patients. Alere i delivers clinically meaningful and actionable results to clinicians–enabling them to treat patients more quickly and appropriately."
The clearance comes after Alere divested its triage and blood gas assets in order to gain the required regulatory clearances to go ahead in its deal to be acquired by Abbott. After months of back-and-forth—including a $50 million breakup offer and lawsuits to halt the deal, as well as to try to force it—the pair settled on new acquisition terms in April. The deal is slated to close this week.