Countable Labs received CE marking for its Countable 4 single-molecule PCR platform, expanding availability in Europe and supporting work in variant detection, rare event quantification, and biologics quality workflows. The company said its Countable PCR approach can detect variants at down to 0.004% variant allele frequency across a range of inputs, while also enabling multiplexing and high dynamic range without relying on standard curves or Poisson statistics. Countable Labs positioned the instrument for biopharma and contract manufacturing teams, including applications tied to AAV and genomic impurities, genome titer and integrity, pathogen quantification, and environmental and food safety monitoring. The platform uses CFR Part 11-compliant software and is now available in Europe and countries recognizing CE. For quality and compliance-focused teams, CE marking reduces geographic friction and adds an additional single-molecule option alongside sequencing-based benchmarking for low-frequency signals.