12:00 PM EDT, 04/02/2024 (MT Newswires) -- (Updates with the latest stock price movement and withdrawal of RVP4+ assay 510(k) submission.)

QuidelOrtho ( QDEL ) shares were down 9.6% in recent Tuesday trading after the company said it decided to withdraw its US Food and Drug Administration 510(k) submission for the Savanna Respiratory Viral Panel4+ assay.

The company made the submission in July after data generated over a nine-month period for the four viruses targeted by the assay showed "great promise," QuidelOrtho ( QDEL ) said. However, the final dataset submitted in February failed to meet expectations, the company said.

QuidelOrtho ( QDEL ) said it continues to develop the new RVP4+ assay and expects it to be commercially available during the 2024/2025 respiratory season.

The company also said its QuickVue COVID-19 test has received 510(k) clearance from the FDA, allowing the test to be used at home and in medical facilities with CLIA certificates of waiver.

Price: 42.50, Change: -4.50, Percent Change: -9.57