Countable Labs Brings Innovative, Single-Molecule, Counting-Based PCR to European Markets with CE Mark Clearance

Countable PCR delivers single-molecule precision for Europe's most demanding quantification challenges — from cell and gene therapy manufacturing to biomarker validation, diagnostics, commercial testing and beyond

PALO ALTO, Calif.--(BUSINESS WIRE)--Countable Labs, the developer of Countable PCR, the leading PCR innovation transforming how science measures biology, achieved CE marking for its Countable 4 Platform, a single-molecule PCR instrument for molecular quantification featuring Countable PCR technology. The platform is ideal for any genomics application where rare events need to be identified and measured completely and accurately against high background samples.

Countable PCR is a highly scalable, digital PCR-like technology that achieves the highest sensitivity and precision of any PCR technology on the market. With more than 10 times the sensitivity and precision of other PCR solutions, Countable PCR facilitates the identification of rare events as low as 0.004% variant allele frequency (VAF), across a wide range of sample inputs. Capable of simultaneously delivering robust sample multiplexing, unparalleled dynamic range, and unmatched ease-of-use, Countable PCR is the alternative that digital PCR and qPCR customers have been waiting for to achieve true single-molecule quantification with no Poisson statistics, no standard cures, and no ambiguity.

“Achieving CE mark is a pivotal moment for Countable Labs as it expands our reach to support European customers,” said Giovanna Prout, Countable Labs’ CEO. “Countable PCR bridges the gap between older generations of PCR and next-generation sequencing with clear data, immediate results, less instrument variability, and economics that make decentralization possible, because virtually any company or laboratory can own and operate the Countable Platform.”

Countable 4 is purpose-built for biopharma and CDMO teams where accurate quantification is required. With CFR part 11 compliant software, and high sensitivity, it’s already being used to quantify genome titer and integrity as well as quantify impurities against complex AAV and genomic backgrounds, delivering the precision and audit-ready data that GMP manufacturing demands. The same platform also serves researchers working in rare variant detection, pathogen quantification, and environmental and food safety monitoring.

"European biopharma and industrial customers face the same precision demands as their U.S. counterparts, and they deserve access to best-in-class quantification solutions," said Dries Van Hemelen, Ph.D., Countable Labs’ Head of Sales and Support for Europe, the Middle East and Africa. "We're ready to support them as they experience a better way to approach PCR testing to advance innovation.”

Cell and gene therapy pioneers are among the early adopters taking notice. “Countable PCR represents a genuine leap forward in molecular quantification. I like the simplicity of direct target counting, rather than relying on Poisson-based inference,” said David Dobnik, Ph.D., Assistant Professor, National Institute of Biology. “Countable PCR handles quantification of challenging samples, such as rare targets against a high background matrix, with remarkable precision.”

Dr. Dobnik will present at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting May 11-15, 2026, in Boston, Mass. His talk, “Rapid, High-Resolution Multiplex Characterization of DNA Impurity Integrity in rAAV Products using Single-Molecule Partitioning" will occur Thursday, May 14, 2026, from 8 - 8:15 a.m. ET. Countable Labs will also be exhibiting in booth #1409. Following ASGCT, he will present on a Drug Discovery News webinar, May 21, 2026, at 11 a.m. - noon ET. For more information, or to register, click here.

Countable PCR is now available in Europe and countries recognizing the CE mark. For more information, visit https://countablelabs.com/countable-pcr.

About Countable Labs

Countable Labs (formerly Enumerix) is redefining PCR with single-molecule precision and category-defining sensitivity, overcoming the limitations of other PCR and next-generation sequencing approaches. The company’s Countable PCR technology delivers at least 10 times the sensitivity and precision of other PCR technologies in a single reaction. Plus, Countable PCR’s single-molecule isolation enables 10-color multiplexing and simplifies assay development. Founded in 2019 by Stephen Fodor, Ari Chaney, and Christina Fan, Countable Labs is privately held and supported by leading life sciences tools investors including ARCH Venture Partners and F-Prime Capital. The company is headquartered in Palo Alto, Calif. Visit www.countablelabs.com to learn more or follow the company on LinkedIn or YouTube.