FDA Approves Rapid Flu & Strep Assays

The US Food and Drug Administration (FDA) has approved a point-of-care influenza (flu) A & B 2 and Strep A 2 molecular assay test that has been shown to improve on the fastest time to results among marketed assays.

Abbott’s pair of assays—hosted on the ID NOW platform—has been granted a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. The flu assay offers a point-of-care molecular detection and flu A & B differentiation result in 13 minutes or less, with a compact storage system that allows streamlined tests.

The Strep A 2 assay, which provides a molecular detection of Group A Streptococcus bacterial nucleic acid, is capable of providing results in 6 minutes or less. Its positive results can be called out in as early as 2 minutes, with no culture confirmation required.

The assays are supported by the ID NOW platform, the first CLIA-waived point-of-care molecular platform, with instrument-based isothermal system for the qualitative detection of infectious diseases. The initial flu A & B and Strep A assays for the platform were approved for marketed use in 2014 and 2015, respectively, with a third assay indicated for respiratory syncytial virus was cleared 2016.

With the FDA approval, Abbot now anticipates to offer new assays for use this fall. It has been a particular busy week for marketed flu therapies—a quadrivalent flu vaccine was granted indication for pediatric patients, and baloxavir marboxil (Xofluza) was approved for the treatment of flu in early-symptom patients.

“These Influenza A & B 2 and Strep A 2 assays combine speed with efficacy for rapid delivery of molecular results, further driving value for healthcare systems where time equals money," said Sharon Bracken, senior vice president of Rapid Diagnostics, Abbott. "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."

Gregory J. Berry, PhD, director of Molecular Diagnostics, Northwell Health Laboratories in Lake Success, NY, said the ability to obtain early call outs for positive test results with molecular accuracy in such short time is a “game-changing development” for treatment purposes.

“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,” Berry said.