Monday, January 23, 2012

Alere's rapid flu test gets FDA waiver

By Lori Valigra

Alere Inc., a Waltham healthcare management company, said today that it received clearance from the U.S. Food and Drug Administration (FDA) for its influenza A&B test for the U.S. market.

The FDA categorized the test as CLIA-waived. The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988, establishing quality standards for all lab testing for accuracy, reliability and timeliness of patient test results. In 2008, the FDA, which determines which tests are eligible for waiver, set more stringent guidelines for in vitro (test tube-type) diagnostics to assure that only accurate and easy-to-use tests reach the physician’s office. Testing must be performed by the intended user, such as a nurse, medical assistant, or doctor, as opposed to a specially trained lab technologist.

Alere said its test is sensitive and rapid, and is intended for use in the physician’s office to help healthcare practitioners better manage patients with flu-like illness.

“By getting this product into the waived segment of the marketplace, we 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,” Avi Pelossof, vice president of infectious disease at Alere, said in a statement. The test uses a nasal swab and provides results in 10 minutes, the company said.

Alere last July closed senior secured credit facilities worth a total of $2.1 billion.