Abbott (NYSE:ABT) announced today that it received FDA emergency use authorization (EUA) for its Alinity m Resp-4-Plex molecular assay.
The laboratory PCR diagnostic is designed to detect and differentiate between SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B and respiratory syncytial virus (RSV) in one test. It already has CE Mark approval and is available in other countries outside the U.S., according to a news release.
Abbott Park, Ill.-based Abbott’s Alinity m Resp-4-Plex test uses one swab specimen (anterior nasal or nasopharyngeal) collected by a healthcare provider or self-collected at a healthcare location. The test will run on Abbott’s Alinity m system using PCR technology.
The company said that, along with providing diagnostic results for four separate viruses, offering flexibility and efficiency, it will also ease the resource strain on collection devices that remain in high demand amid the COVID-19 pandemic.
News of the latest EUA follows the FDA’s announcement earlier this week that it authorized the AdviseDx SARS-CoV-2 IgG II antibody serology diagnostic.
“Abbott has been developing and introducing tests that have been playing a critical role in fighting the pandemic. The need for a combination of testing methods in different settings has never been more clear,” Abbott EVP of rapid & molecular diagnostics Andrea Wainer said in the release. “This newest test will allow for fast and efficient diagnosis and triage of patients who present with respiratory symptoms so they can be given the right care.”
In addition to EUA for the Alinity m Resp-4-Plex test, Abbott said its EUA for the Alinity m SARS-CoV-2 test was updated to include an asymptomatic claim and to include a pooling claim to allow up to five samples to be tested at the same time.