WALTHAM, Mass. — Alere on Thursday announced the availability in Europe of the Alere i Influenza A & B test, a molecular test that detects and differentiates influenza A and B virus in less than 15 minutes. The test is now commercially available in Austria, France, Spain, Switzerland, Germany, Italy and the U.K.
"Alere i is a transformational platform that allows healthcare professionals to make a rapid influenza diagnosis — and effective patient management decisions — in a clinically meaningful timeframe, whether the patient is in the physician office, emergency department or urgent care clinic," stated Avi Pelossof, Alere global president of infectious disease. "Alere i also significantly expands screening opportunities by making innovative, rapid molecular testing technology available at the point of care as well as in laboratory settings."
Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform, the company stated. The proprietary technology utilizes isothermal nucleic acid amplification technology, which, unlike polymerase chain reaction testing, does not require temperature cycling and can therefore deliver results more quickly and to a broader range of settings.
Alere i tests for Strep A, C. difficile, respiratory syncytial virus and chlamydia/gonorrhoea are currently in development.
Alere i Influenza A & B is currently under regulatory review in the United States by the Food and Drug Administration and is not available in the U.S. pending completion of such review.