Countable Labs, the developer of Countable PCR, the leading PCR innovation transforming how science measures biology, announced specialized assay services helping cell and gene therapy (CGT) developers and manufacturers understand and validate Countable Labs’ solutions to accelerate adoption of Countable PCR technology. The news comes at the American Society of Gene+Cell Therapy (ASGCT) meeting taking place May 11-15, 2026, in Boston, Mass., where the company and its collaborators will be presenting their successes in using Countable PCR technology for single-molecule counting to eliminate variability in CGT workflows. The company will also launch its “Count What Counts” grant program, giving one lucky scientist or researcher access to a free Countable PCR CGT pilot study.
Cell and gene therapy requires accuracy and reproducibility in every reaction because product quality is paramount and regulatory standards are high. Many assays can measure titer or detect impurities, but Countable PCR’s uniquely straightforward single-molecule quantification technology minimizes variability and maximizes precision. Countable PCR can combine multiple assays for CQA-focused analytical development and, without requiring Poisson statistics or manual thresholding, deliver reliable and reproducible data. Unlike other PCR methods, Countable PCR combines these capabilities with DNA linkage analysis, simplifying genome integrity analysis.
“Cell and gene therapy applications require complete, unambiguous answers,” said Giovanna Prout, Chief Executive Officer at Countable Labs. “Countable PCR is the ideal technology for true single molecule counting, delivering highly reproducible results. Our assay services are designed for proof-of-concept studies, leveraging purpose-built assays to measure critical metrics for cell and gene therapy quality control enabling faster implementation into routine, high volume workflows.”
Countable Labs’ assay services enable measurement of genome integrity and titer, detection of residual DNA, and quantification of plasmid-derived impurities, producing audit-ready data. A new linkage visualization tool surfaces these data in a single view, giving scientists an exact picture of every vector or cell line’s composition at a glance.
The services are designed as a rapid proof-of-concept entry point, giving CGT teams the data they need to validate Countable PCR against their own samples and workflows to expedite platform adoption in-house or by a CDMO partner. With the ability to run thousands of samples with consistent results, Countable PCR is built to scale alongside CGT programs from early development through manufacturing, supporting routine, high-throughput quality control across development and manufacturing pipelines.
“Countable PCR proved invaluable for quantifying sequence integrity of low-level impurities even against a dominant background of the AAV capsids and genomes,” said David Dobnik, Ph.D., Assistant Professor, National Institute of Biology. “The platform reliably resolved and quantified minor impurity species, providing critical information needed to meet the quality standards required in gene therapy applications.”
Count What Counts Grant Program
The Count What Counts grant program invites scientists and researchers solving the hardest problems in CGT to put Countable PCR technology to work on their questions. One winner will receive a complimentary pilot project using Countable Labs’ assay services, including pre-designed Countable PCR assays and publication-ready data output. Applicants will select from validated, pre-designed assays covering up to four targets and submit a brief project proposal describing how Countable PCR would support their work. Applications open on May 11, 2026 at 9 a.m. PST, and close July 17, 2026 at 11:59 p.m PST. The winning project will be announced in early September. To apply or learn more, visit makeitcount.countablelabs.com/count-what-counts-grant.
Meet Countable Labs at ASGCT
Countable Labs is looking forward to connecting with the CGT community at ASGCT 2026 through our scientific talk and poster presentations with Dr. David Dobnik, Carrigent, and AAVnerGene. Visit us in booth #1409 to see how Countable PCR is bringing single-molecule precision to CGT and improving confidence at every step – including measuring genome integrity, genome titer, or impurities – in a single reaction.
Scientific Talk: Rapid, High-Resolution Multiplex Characterization of DNA Impurity Integrity in rAAV Products using Single-Molecule Partitioning
Presented by David Dobnik, Ph.D., Assistant Professor, National Institute of Biology
Time: Thursday, May 14, 2026, from 8 – 8:15 a.m. ET
Location: MCEC Room 206AB (Level 2)
Poster #1066: Early vector copy number determination and integration assessment for cell therapy using single-molecule PCR
Presented in collaboration with Carrigent
Time: Tuesday, May 12, 2026, from 5:00 – 6:30 p.m. ET
Poster #2218: Rapid assessment of AAV genome integrity using multiplexed PCR with single-molecule detection
Presented in collaboration with AAVnerGene
Wednesday, May 13, 2026, 5:00 – 6:30 p.m. ET
For more information, visit https://makeitcount.countablelabs.com/count_what_counts_cgt.
About Countable PCR
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 curves, and no ambiguity.
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 streamlines 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, F-Prime Capital, and Premier Ventures. The company is headquartered in Palo Alto, Calif. Visit www.countablelabs.com to learn more or follow the company on LinkedIn or YouTube.
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