Baebies said it obtained 510(k) clearance and a CLIA waiver for a triplex respiratory test on its Finder multifunction point-of-care system, combining molecular testing with additional cleared modalities. The announcement makes Finder the first multifunctional point-of-care instrument cleared to run molecular testing alongside another modality on a single platform. The triplex assay targets influenza A, influenza B, and SARS-CoV-2 using ultra-rapid qPCR, with Baebies describing the cartridge architecture as enabling higher multiplexing. The company also said its multiplexing capability can reach 48 targets and could support more. For decentralized care models, the clearance is a practical step toward expanding near-patient virology testing capacity while reducing lab turnaround constraints.
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