SUNDAY, SEPTEMBER 25, 2016

Alere influenza test receives FDA approval

Alere, Inc., announced on Monday that it received clearance from the U.S. Food and Drug Administration for its Alere i Influenza A & B test.

The Alere clinical trials were held at eight sites in the U.S. during the 2012-2013 flu season. The company tested 585 nasal swab specimens from patients exhibiting influenza-like symptoms with Alere i. All discrepant results between the Alere test and the viral culture were tested using an FDA-approved RT-PCR assay to confirm that influenza was present.

The Alere i tests are now the first FDA-approved diagnostics that can detect and differentiate between influenza A and B virus in less than 15 minutes.

"By providing the speed of a rapid test with molecular technology, Alere i delivers clinically meaningful and actionable results to clinicians, enabling them to treat patients more quickly and appropriately," Avi Pelossof, the global president of infectious disease at Alere, said.

Alere i Influenza A & B was launched in Europe earlier this year.

Headquartered in Waltham, Mass., Alere focuses on infectious diseases, toxicology, cardiology and diabetes. The company is currently developing similar tests for strep A, Clostridium difficile, respiratory syncytial virus, chlamydia and gonorrhea.

Influenza is responsible for approximately 150,000 hospitalizations each year in the United States.