Countable Labs

Countable Labs

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Private Company

Funding information not available

Overview

Countable Labs is a private, commercial-stage company offering a breakthrough PCR platform that directly counts individual DNA molecules with high precision. Its Countable PCR technology claims significant advantages over existing methods, including 10x better sensitivity than dPCR, automated real-time analysis, and simplified multiplex assay development. The company has achieved CE marking for its Countable 4 system, indicating initial regulatory approval for the European market and validation from key opinion leaders in clinical diagnostics, rare event detection, and cell & gene therapy.

OncologyInfectious DiseaseGenetic Disorders

Technology Platform

Countable PCR: A nucleic acid quantification platform that uses ~30 million compartments per reaction to physically isolate and directly count single DNA molecules via a laser-based multi-color optical system, enabling true absolute quantification without Poisson statistics.

Opportunities

The platform addresses critical unmet needs in high-growth areas like liquid biopsy, minimal residual disease monitoring, and cell/gene therapy QC, where extreme sensitivity and precision are paramount.
Its ease of use and lower projected total cost could drive rapid adoption in both research and clinical settings, displacing portions of the large qPCR and dPCR markets.

Risk Factors

Major risks include overcoming market inertia against established PCR giants, scaling manufacturing for a complex instrument, and achieving broader regulatory clearances (e.g., FDA) for clinical use.
Technical performance must be consistently validated across diverse real-world labs to build trust.

Competitive Landscape

Countable PCR directly competes with established quantitative PCR (qPCR) systems from companies like Thermo Fisher, Bio-Rad, and Roche, and digital PCR (dPCR) systems from Bio-Rad (ddPCR) and Thermo Fisher (QuantStudio). Its key differentiators are claimed superior sensitivity (10x better than dPCR), higher precision, easier multiplexing, and automated analysis, positioning it as a potential best-in-class solution for absolute quantification.