Countable Labs offers the Countable PCR platform, which partitions reactions into ~30 million micro‑compartments to perform direct single‑molecule counting and deliver absolute quantification with a limit of detection of 0.004 % mutant allele frequency. The system supports up to 10‑plex fluorescence multiplexing without custom probe design and provides automated real‑time analysis, reducing assay development time and per‑sample cost for molecular diagnostics and research labs.
Funding
Funding not disclosed
Founders
Product
Problem
Conventional quantitative PCR (qPCR) provides only relative quantification, while digital PCR (dPCR) delivers statistical estimates, requires extensive assay development, and suffers from limited multiplex capacity and high per‑sample cost. These constraints impede sensitive detection of low‑frequency variants and rare events in clinical and research workflows.
Solution
Countable Labs’ Countable PCR platform replaces relative Ct‑based measurements and Poisson‑based estimates with true direct single‑molecule counting. By partitioning each reaction into ~30 million micro‑compartments, the system achieves a limit of detection down to 0.004 % mutant allele frequency and a coefficient of variation around 1 %, delivering absolute quantification across a broad dynamic range. The technology supports out‑of‑the‑box multiplexing (up to 10 fluorescent channels) without custom probe design or signal‑balancing, enabling rapid assay development and real‑time, automated result reporting. Compared with legacy PCR methods, Countable PCR reduces reagent and labor costs by roughly threefold while delivering faster turnaround times, making high‑precision rare‑event detection practical for routine laboratory use.
Target Audience
Primary customers are molecular diagnostics laboratories, biotech R&D teams, and academic research groups developing oncology, NIPT, infectious disease, and cell‑&‑gene therapy assays that require high‑sensitivity rare‑event detection and multiplexed quantification.
Features
- ~30 million partitioned reaction volume providing ultra‑high sensitivity and 99.9 % sample recovery
- Direct single‑molecule counting eliminates the need for Ct thresholds or Poisson modeling, yielding unbiased absolute copy numbers
- 4‑color (Countable 4) and 10‑color (Countable 10) optical configurations enable up to 10‑plex fluorescence multiplexing in a single reaction
- No custom probes or signal‑balancing required; assay setup is completed in minutes, accelerating development cycles by up to 10×
- Real‑time data acquisition and automated analysis pipeline deliver instant, objective results without manual thresholding
- Broad dynamic range spanning several orders of magnitude, suitable for both high‑abundance and ultra‑low‑frequency targets
- Compatible kits for DNA and RNA templates, supporting applications in oncology, NIPT, infectious disease, and cell‑&‑gene therapy
- Instrument platforms (Countable 4, Countable 10) designed for easy integration into existing lab automation workflows