Alere Inc., a global leader in point-of-care rapid diagnostics and other health information solutions, has received FDA clearance for the Alere™ i Influenza A and B Test. This is the first and only molecular test to identify and differentiate influenza A and B virus in less than 15 minutes. This in-vitro immunochromatographic assay is designed for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients.
As influenza viruses can cause severe illness, on-time diagnosis is important for immediate, effective treatment decisions. Rapid diagnosis of influenza can also lead to reduced hospital stays, reduced secondary complications and reduced cost of hospital care, and allow effective implementation of infection control measures.
In a press release announcing the availability of the test in Europe in January Avi Pelossof, Alere Global President of Infectious Disease said, “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”.
Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. The user-friendly Alere assay performs such testing in less than 15 minutes. Its unique isothermal nucleic acid technology removes the need for thermal cycling or sample purification steps. The LCD touch screen application and visual guides make running a test and interpreting the results fast and easy. With its small footprint and easy to use graphical user interface, the platform is ideal for a point-of-care environment.
A multi-center, prospective study conducted at eight U.S. trial sites during the 2012-2013 flu season established the clinical performance of this flu test. Up to 585 prospective nasal swab specimens collected from patients presenting with influenza-like symptoms were evaluated with Alere i and compared to viral culture. All specimens generating discrepant results between the Alere i Influenza A & B test and viral culture were tested using an FDA cleared RT-PCR assay to confirm influenza status.
Clinical trials for CLIA waiver of Alere i Influenza A & B have been completed and the Company expects to submit a CLIA waiver filing to the FDA in early Q3 2014. Clinical trials for Strep A have also been completed and Alere expects to file for 510k clearance in Q3 2014.