Baebies received 510(k) clearance and a CLIA waiver for a triplex respiratory test on its Finder point-of-care instrument, enabling detection of influenza A, influenza B, and SARS-CoV-2. The clearance positions the system as the first multifunctional POC instrument to combine molecular testing with another cleared test modality on the same platform. The company described the approach as based on ultra-rapid qPCR rather than endpoint PCR, with spatial thermal cycling that shuttles reaction droplets among temperature and detection zones within small cartridges. Baebies said its cartridge architecture supports higher multiplexing, with 48 targets already achieved and more theoretically possible. This is a commercially meaningful step for POC diagnostics that need broader respiratory coverage and higher throughput without adding lab infrastructure.
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