Countable Labs obtained a CE mark for its Countable 4 single-molecule PCR platform, extending access to European biopharma and contract manufacturing customers. The company described the instrument as a digital PCR-like system capable of detecting rare variants across sample inputs with multiplexing and broad dynamic range. Countable Labs said Countable PCR can quantify genome integrity and titer, measure impurities against complex AAV and genomic backgrounds, and support research and monitoring in rare variant detection and pathogen quantification. The platform uses CFR Part 11-compliant software and is positioned for decentralized operations where labs can operate the system in-house. For regulated workflows, the CE mark is a practical milestone because it shortens the path to commercialization and can reduce time to instrument deployment at European sites. The move comes as the diagnostics market increasingly demands high-sensitivity nucleic acid quantification for gene therapy manufacturing, quality, and release testing.