Alere Inc. 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 Influenza A & B
test, the only molecular test to detect and differentiate influenza A and B
virus in under 15 minutes. Alere i Influenza A & B is the first-ever molecular
test to receive a CLIA (Clinical Laboratory Improvement Amendments) waiver,
which allows for broad use by healthcare providers, ranging from hospitals and
physician offices to clinics and other healthcare settings.
First-ever CLIA-waived molecular flu test delivers lab-accurate results at the
point of care in less than 15 minutes
"This milestone greatly expands the availability of molecular testing to a
wide range of healthcare settings during this influenza season," said 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."
The Alere i test was cleared for marketing by the FDA in June 2014, and was
made available in September for health facilities and laboratories licensed to
conduct tests of moderate complexity under the CLIA program. With CLIA waiver,
the test will be available in a significantly broader range of healthcare
settings.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in