Alere wins FDA CLIA waiver for rapid flu test

24 January 2012 (Last Updated January 24th, 2012 18:30)

Alere has received a clinical laboratory improvement amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its influenza A&B test.

Alere has received a clinical laboratory improvement amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its influenza A&B test.

The Alere influenza A&B test, which collects samples through a minimally invasive nasal swab method, utilises highly sensitive antibodies to detect influenza type A and B antigens. The test provides accurate, reliable and timely patient results, wherever they are performed.

The company said the new Alere test, when compared to the viral culture, showed performance with sensitivity / specificity of 93.8% / 95.8% for flu A and 77.4% / 98% for flu B. The highly sensitive rapid test provides results in ten minutes, making it possible for physicians to administer treatment while patients are still in their care.

The Alere influenza A&B test also adds a dipstick format test to Alere's existing portfolio of influenza diagnostics, which includes the card format BinaxNOW influenza A&B Test, helping the company to provide primary care physicians with a full range of easy-to-use, effective tools for identifying influenza A and B at the point of care.

Alere Infectious Disease vice-president Avi Pelossof said that by getting this product into the waived segment of the marketplace, they are giving healthcare providers a new tool that will enable them to make better decisions about flu diagnosis and treatment while patients are still in the office.

Alere develops new capabilities in near-patient diagnosis, monitoring and health management, which helps individuals to take charge of improving their health and quality of life at home. The company's products and services, as well as its new product development efforts, focus on cardiology, women's health, infectious disease, oncology and toxicology.