Countable Labs secured CE marking for its Countable 4 single-molecule PCR platform, positioning the instrument for European biopharma and contract manufacturing customers. The company says its technology can detect rare events down to approximately 0.004% variant allele frequency, with robust multiplexing and high dynamic range. Countable framed the instrument as bridging conventional PCR and next-generation sequencing, emphasizing workflow outputs including genome titer and integrity quantification for AAV and genomic samples. The platform is designed with CFR Part 11-compliant software and is now available in Europe in countries that recognize CE marking. The CE win is expected to support adoption for rare variant detection, pathogen quantification, and other regulated quantification use cases where rapid, instrument-owned workflows are preferred.