Countable Labs announces additional modules for Countable PCR expanding its utility for translational research, cell and gene therapy manufacturing, and diagnostic development

PALO ALTO, Calif.-(BUSINESS WIRE)--Countable Labs, the developer of Countable PCR, the leading PCR innovation transforming how science measures biology, announced the launch of the RNA Module for Countable PCR. This new solution brings direct counting of RNA to the Countable PCR platform, enabling one-step, bias-free RNA quantification, and delivering the simplicity, accuracy, and low variability essential to researchers across a range of translational, biopharma, and research applications. In addition, the company will share new data at the Association for Molecular Pathology Annual Meeting and Expo, November 11-15, 2025, in Boston, Mass.

Countable PCR is a highly scalable PCR technology leveraging single-molecule isolation across 30 million compartments per experiment to achieve true single-molecule quantification from a simple PCR workflow. The technology offers the highest sensitivity available from PCR, at least 10 times the sensitivity and precision of other PCR technologies, facilitating the identification of rare events as low as 0.004% variant allele frequency (VAF), even with small sample inputs.

The RNA Module for Countable PCR simplifies the workflow for RNA samples by eliminating the need for cDNA generation prior to Countable PCR, allowing users to directly load RNA for one-step reverse transcription and amplification, enabling accurate RNA quantification with lower variability. This technology enables the rapid detection of fusion transcripts, pathogens, as well as the accurate quantification of RNA viral load, minimal residual disease (MRD), and other RNA molecules of interest. Unlike other PCR-based RNA methods, Countable PCR with the RNA module delivers absolute RNA quantification with a broad dynamic range (1 to 1 million target molecules per reaction), sensitivity for viral RNA down to 0.001%, and minimal variability.

“Our team has transformed the capabilities of legacy PCR techniques by developing Countable PCR to have superior performance, the highest multiplexing available, and a level of simplicity that addresses the shortcomings of qPCR, digital PCR, and even next-generation sequencing,” said Giovanna Prout, CEO of Countable Labs. “DNA and RNA applications are just the beginning of Countable Labs’ story. We are focused on developing a robust product portfolio of multiomics and assays to support a broad range of clinical, translational, and research customers.”

To assist customers in building experiments for Countable Labs’ systems, the company launched a new Community Assays portal. This portal is designed to accelerate Countable PCR adoption by enabling customers to access pre-designed and pre-verified assays for different applications. These assays remove the burden of design for researchers just getting started with Countable PCR and create a community-driven resource for scientific innovation and collaboration.

“There is a broad range of high-value applications for PCR-based RNA testing in applications where other PCR approaches are insufficiently specific, and next-generation sequencing is not practical or economical,” said Eleen Shum, Vice President of Product and Founding Scientist at Countable Labs. “Our direct counting approach makes accurate quantification reactions easier to complete and most cost-effective for applications as diverse as lentivirus quality control in cell and gene therapy manufacturing to minimal residual disease detection in cancer research.”

Countable Labs will discuss its one-step RNA fusion quantification solution for MRD monitoring with Countable PCR at a webinar on December 11, 2025. Register here.

Company to share data at AMP annual meeting and expo

Countable Labs will be exhibiting at AMP, showcasing its recently launched Countable PCR instrument in booth #228. In addition, the company will participate in a workshop with Promega and present four posters.

Workshop: Detect more biomarkers, faster: Combining 10-Color PCR and automated rapid ccfDNA extraction.
Room: 160A, Level 1
Time: Wednesday, November 12, 2:00–2:50 p.m. EST

Poster #H064: Single-molecule quantification of BCR-ABL1 fusion transcripts in a single-tube workflow using PCR-based RNA counting.
Time: Friday, November 14, 9:15 – 10:15 a.m. EST
Category: Hematopathology

Poster #ST098: Quantitative detection of high-risk HPV subtypes in oropharyngeal cancer using single-molecule PCR.
Time: Friday, November 14, 9:15 – 10:15 a.m. EST
Category: Solid tumors

Poster #ID020: Multiplexed single-tube detection of Trypanosoma cruzi DNA with million-fold dynamic range using single-molecule PCR.
Time: Friday, November 14, 9:15 – 10:15 a.m. EST
Category: Infectious diseases

Poster #TT043: Development of a single-tube, 8-color PCR assay for quantifying a KRAS mutation panel using true single-molecule counting.
Time: Saturday, November 15, 9:15 – 10:15 a.m. EST
Category: Technical topics

For more information, visit www.countablelabs.com.

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.

Countable Labs current products are for Research Use Only.

Contacts

For media:
Gwen Gordon
gwen@gwengordonpr.com

For all other inquiries:
hello@countablelabs.com