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QuidelOrtho Withdraws Submitted Savanna Respiratory Panel, Obtains FDA Clearance for COVID-19 Test

NEW YORK – QuidelOrtho announced Tuesday that it has withdrawn the US Food and Drug Administration submission for its Savanna RVP4+ molecular assay.

Shares of QuidelOrtho tumbled on the news, falling approximately 10 percent to $42.13 by the late afternoon.

The Savanna instrument and a respiratory panel called RVP4+ — containing targets for influenza A and B, respiratory syncytial virus, and SARS-CoV-2 — obtained the CE mark in July 2021. The Savanna instrument obtained FDA clearance in late 2023 along with the firm's Savanna HSV 1+2/VZV PCR assay. A potential FDA clearance and CLIA waiver of the RVP4+ was expected to "jump-start" Savanna sales, the firm's executives said at a recent investor conference.

However, the company said in a statement on Tuesday that while "data generated during a nine-month period for the four viruses targeted by [RVP4+] initially showed great promise," leading to its submission to the FDA last summer, "the final dataset, submitted in February 2024, did not meet our expectations."

The firm said it has also continued to develop the panel in the interim and plans to make a next-generation RVP4+ panel available for the 2024/2025 respiratory season.

QuidelOrtho also said that it remains committed to expanding the Savanna platform menu, and that it is "making good progress" on a sexually transmitted infection panel and expects to begin clinical trials later in the second quarter.

The San Diego-based firm also announced on Tuesday that it has obtained FDA 510(k) clearance and CLIA waiver for its QuickVue COVID-19 antigen test.

The QuickVue COVID-19 test is for use by people ages 14 and older with symptoms of infection and can be used within six days of symptom onset. The test can also be used on children ages 2 and older when administered by an adult. A negative test requires retesting within 72 hours using an antigen or molecular test.