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FDA Watch: Agency Approves New Flu Tests and Drug

by | Dec 14, 2018

As the flu season begins, the FDA has issued significant approvals of new products for diagnosing and treating the disease. New Flu Assays On October 24, Abbott announced that the FDA has granted CLIA waivers for its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The new assays […]

As the flu season begins, the FDA has issued significant approvals of new products for diagnosing and treating the disease.

New Flu Assays
On October 24, Abbott announced that the FDA has granted CLIA waivers for its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The new assays enable the fastest ever time-to-results, Abbott claims.

The enhanced Influenza A & B 2 assay offers point-of-care molecular detection and differentiation of influenza A and B virus in 13 minutes or less, with early call out of positive results in as little as five minutes. It also allows for room temperature storage of all test components, simplifying and streamlining test ordering and storage.

The Strep A 2 provides molecular detection of Group A Streptococcus bacterial nucleic acid, the primary cause of bacterial pharyngitis (sore throat), in six minutes or less, with call out of positive results as early as two minutes with no culture confirmation required for negative results.

The new assays are available in a broad range of outpatient and inpatient settings where patients are increasingly accessing healthcare services, including emergency rooms, physician offices, walk-in clinics and urgent care centers.

First New Flu Treatment Drug in 20 Years
The FDA also approved Roche Group member Genentech's Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated flu influenza in patients 12 years of age and older who've been symptomatic for no more than 48 hours. This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years, noted FDA Commissioner Scott Gottlieb, M.D. He cautions, however, that antiviral drugs to treat flu are no substitute for yearly vaccination.

The CDC currently recommends three antiviral drugs to treat the flu:

  • Tamiflu (oseltamivir) (Roche);
  • Relenza (zanamivir) (GlaxoSmithKline); and
  • Rapivab (peramivir) (BioCryst).

Last year's severe flu season saw increased demand and spotty shortages of Tamiflu.

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