Friday, March 17, 2023
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Industry News

Alere Receives FDA Clearance for Rapid Influenza A and B Test

by Global Biodefense Staff
July 7, 2014

Alere Inc., a global provider of point-of-care rapid diagnostic and health information solutions, recently announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Alere™ i Influenza A & B test, the first molecular test to detect and differentiate influenza A and B virus in less than 15 minutes.

“By providing the speed of a rapid test with molecular technology, Alere i delivers clinically meaningful and actionable results to clinicians – enabling them to treat patients more quickly and appropriately,” said Avi Pelossof, Alere Global President of Infectious Disease.

The clinical performance of Alere i Influenza A & B was established in a multi-center, prospective study conducted at eight U.S. trial sites during the 2012-2013 flu season, in which 585 prospective nasal swab specimens, collected from patients presenting with influenza-like symptoms, were evaluated with Alere i, and compared to viral culture. All specimens generating discrepant results between the Alere i Influenza A & B test and viral culture were tested using an FDA cleared RT-PCR assay to confirm influenza status.

Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. Unlike polymerase chain reaction (PCR) testing, Alere’s proprietary Molecular In Minutes (MIM) isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results more quickly – and in a broad range of settings. Alere i tests for Strep A, C. difficile, respiratory syncytial virus (RSV) and chlamydia/gonorrhea are currently in development.

Alere i Influenza A & B was launched earlier this year in Europe. Clinical trials for CLIA waiver of Alere i Influenza A & B have been completed and the Company expects to submit a CLIA waiver filing to the FDA in early Q3 2014. Clinical trials for Strep A have also been completed and the Company expects to file for 510k clearance in Q3 2014.

Alere is headquartered in Waltham, Massachusetts. Alere Inc. The company recently announced that it had elected not to proceed with plans to pursue an initial public offering in the United Kingdom of the ordinary shares of BBI Diagnostics Group plc, or BBI Diagnostics.

Source: Alere Inc., adapted.

Tags: InfluenzaPOC Diagnostics

Related Posts

DARPA Selects Teams to Develop Vaccine Durability Prediction Model
Medical Countermeasures

DARPA Selects Teams to Develop Vaccine Durability Prediction Model

January 13, 2023
small glass vials on an assembly line await filling of vaccine solution
Industry News

Sabin Vaccine Institute to Advance Ebola Sudan and Marburg Vaccines with New BARDA Funding

January 12, 2023
How Are Bivalent COVID Vaccines Stacking Up Against Omicron?
Infectious Diseases

How Are Bivalent COVID Vaccines Stacking Up Against Omicron?

January 12, 2023
NISTCHO: New Living Reference Material for Producing Monoclonal Antibodies
Medical Countermeasures

NISTCHO: New Living Reference Material for Producing Monoclonal Antibodies

January 12, 2023
Load More

Latest News

Biodefense Headlines – 12 March 2023

Biodefense Headlines – 12 March 2023

March 12, 2023
Partner Therapeutics’ Novel Approach to Stratify Sepsis Patients Gains Backing From BARDA

Biopreparedness Research Virtual Environment (BRaVE) Initiative Backed by $105M DOE Funding

January 25, 2023
Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

January 25, 2023
Biodefense Headlines – 24 January 2023

Biodefense Headlines – 24 January 2023

January 24, 2023

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are okay with it.OkPrivacy policy