Abbott Molecular Flu, Strep Tests Get FDA Clearance

NEW YORK (GenomeWeb) – Abbott said today that the US Food and Drug Administration has cleared its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The new assays enable fast time-to-results for molecular influenza A & B and Strep A testing at the point of care, the firm said.

Both assays have also been granted CLIA waivers and are available for use with the Abbott ID Now platform, formerly the Alere i — a rapid, instrument-based, isothermal nucleic acid amplification system for the qualitative detection of infectious diseases. Registrations are pending for marketing of both assays outside the US, the Abbott Park, Illinois-based firm said.

In the US, the assays are available in a broad range of outpatient and inpatient settings, including emergency rooms, physician offices, walk-in clinics, and urgent care centers. 

The Influenza A & B 2 assay provides point-of-care molecular detection and differentiation of influenza A and B virus in 13 minutes or less, and it calls out positive results in five minutes, Abbott said. The assay enables room temperature storage of all test components, which simplifies and streamlines test ordering and storage, it added.

The Strep A 2 test provides molecular detection of group A Streptococcus bacterial nucleic acid, the primary cause of bacterial pharyngitis, or sore throat, in six minutes or less, and it calls out positive results in two minutes. Culture confirmation is not required for negative results.

"By delivering fast and accurate molecular results at the point of care, these tests provide physicians with the confidence to give the right diagnosis and the ability to prescribe the right treatment earlier," Sharon Bracken, senior vice president of rapid diagnostics at Abbott, said in a statement. 

Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, New York, said "Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient's symptoms, and contributes to antibiotic resistance."

The FDA cleared the initial Influenza A & B and Strep A assays for the ID Now platform in 2014 and 2015 respectively. The agency cleared the third assay on the platform, for respiratory syncytial virus, in 2016.  Abbott said it anticipates offering ID Now assays for use with existing Alere i instruments and new ID Now instruments.