FDA grants CLIA waiver for Alere i Strep A test

Alere Inc. (NYSE: ALR), a global leader in rapid diagnostic tests, today announced that the U.S. Food and Drug Administration (FDA) has granted CLIA waiver for the Alere™ i Strep A test. The test, which was cleared for marketing by the FDA in April 2015, is the first molecular platform that detects Group A Streptococcus (GAS) bacteria in 8 minutes or less.

With CLIA waiver, the Alere i Strep A test will be available in a broad range of healthcare settings, including physician offices, hospital emergency rooms, and retail and walk-in clinics in the United States.

"Strep A is highly transmissible, and prompt treatment is critical to reducing the spread of the infection to others. With CLIA waiver for the Alere i Strep A test, we can help link more people to early treatment by bringing rapid molecular diagnosis to even more settings where they seek health care," said Avi Pelossof, Global President of Infectious Disease at Alere.

The Strep A test is the second assay on the Alere i molecular platform, which initially received 510(k) clearance for the detection and differentiation of influenza A and B virus in 2014. In January 2015, Alere i Influenza A & B became the first-ever molecular test to receive CLIA waiver.

Source:

Alere Inc.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Alere Inc.. (2019, June 19). FDA grants CLIA waiver for Alere i Strep A test. News-Medical. Retrieved on September 17, 2019 from https://www.news-medical.net/news/20150716/FDA-grants-CLIA-waiver-for-Alere-i-Strep-A-test.aspx.

  • MLA

    Alere Inc.. "FDA grants CLIA waiver for Alere i Strep A test". News-Medical. 17 September 2019. <https://www.news-medical.net/news/20150716/FDA-grants-CLIA-waiver-for-Alere-i-Strep-A-test.aspx>.

  • Chicago

    Alere Inc.. "FDA grants CLIA waiver for Alere i Strep A test". News-Medical. https://www.news-medical.net/news/20150716/FDA-grants-CLIA-waiver-for-Alere-i-Strep-A-test.aspx. (accessed September 17, 2019).

  • Harvard

    Alere Inc.. 2019. FDA grants CLIA waiver for Alere i Strep A test. News-Medical, viewed 17 September 2019, https://www.news-medical.net/news/20150716/FDA-grants-CLIA-waiver-for-Alere-i-Strep-A-test.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
Post
You might also like... ×
Alere supports DTHF’s Tutu Teen Truck project to expand reach of infectious services for youth