QuidelOrtho withdraws FDA 510(k) submission for RVP4+ assay

QuidelOrtho said earlier that upon reviewing the performance of the Savanna RVP4+ assay against the clinical market’s expectations, a decision was made to withdraw the current FDA 510(k) submission for the Savanna RVP4+ assay. “Data generated over a 9-month period for the four viruses targeted by the assay initially showed great promise, which led to the FDA submission in July 2023. However, the final dataset, submitted in February 2024, did not meet our expectations. In addition, during the pendency of the submission, the company has continued to develop the next-generation RVP4+ assay. The company anticipates the new multiplex assay to be commercially available during the 2024/2025 respiratory season. QuidelOrtho remains committed to expanding the Savanna platform menu. The company is making good progress on a sexually transmitted infection panel and expects to begin clinical trials later in the second quarter.”