FDA has granted Alere, Waltham, Mass, a Clinical Laboratory Improvement Amendments (CLIA) waiver for the Alere i Influenza A & B test, the only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes, and now the first molecular test to receive a CLIA waiver.
FDA originally cleared the test in June 2014. Assignment of waived status for the test enables broad use by healthcare providers, including clinical staff in hospitals, physicians’ offices, clinics, and other healthcare settings. In contrast to polymerase chain reaction (PCR) testing, Alere’s proprietary molecular isothermal nucleic acid amplification technology avoids using time-consuming, complex thermocycling or DNA purification, enabling the test to deliver results more quickly.
“This milestone greatly expands the availability of molecular testing to a wide range of healthcare settings during this influenza season,” says Avi Pelossof, global president of infectious disease at Alere. “By making lab-accurate, actionable results available at the point of care, Alere i empowers healthcare providers to quickly identify and treat people with influenza—improving patients’ clinical outcomes, protecting their communities, and reducing healthcare costs.”
A combination of influenza A and B virus strains circulate in the United States each year, generating an estimated 25 to 50 million cases annually. The virus leads to as many as 150,000 hospitalizations and 3,000 to 49,000 deaths per year, causing a significant economic impact in terms of medical expenses and lost worker productivity. Rapid diagnosis of the virus can improve treatment decisions, reduce hospital stays, and prevent the ineffectual prescribing of antibiotics and antiviral medications.
For more information, visit Alere.