The new module enables one-step reverse transcription and amplification, removing cDNA prep and supporting applications in translational research, cell and gene therapy manufacturing, and diagnostic development.
Countable Labs has launched an RNA Module for its Countable PCR platform, enabling direct RNA quantification without requiring cDNA generation prior to analysis. The technology aims to serve translational research, cell and gene therapy manufacturing, and diagnostic development applications.
The RNA Module allows users to directly load RNA samples for one-step reverse transcription and amplification, eliminating traditional workflow steps. The platform leverages single-molecule isolation across 30 million compartments per experiment to achieve quantification with sensitivity down to 0.004% variant allele frequency, even with small sample inputs.
“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,” says Giovanna Prout, CEO of Countable Labs, in a release.
The technology enables detection of fusion transcripts and pathogens, as well as quantification of RNA viral load and minimal residual disease (MRD). The platform provides absolute RNA quantification with a dynamic range of 1 to 1 million target molecules per reaction and sensitivity for viral RNA down to 0.001%.
Community Portal Supports Assay Development
Countable Labs also launched a Community Assays portal designed to accelerate platform adoption by providing pre-designed and pre-verified assays for different applications. The portal removes design burden for new users and creates a resource for scientific 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,” says Eleen Shum, vice president of product and founding scientist at Countable Labs, in a release. “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.”
The company reports applications include lentivirus quality control in cell and gene therapy manufacturing and MRD detection in cancer research.
Conference Presence and Future Plans
Countable Labs will exhibit at the Association for Molecular Pathology Annual Meeting and Expo, Nov 11-15, 2025, in Boston, showcasing the Countable PCR instrument. The company will participate in a workshop with Promega and present four posters.
The company will also host a webinar on Dec 11, 2025, discussing one-step RNA fusion quantification for MRD monitoring applications.
“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,” says Prout in a release.
Current Countable Labs products are designated for research use only.
Photo caption: RNA Module
Photo credit: Countable Labs
