Countable Labs

Market position

The company positions Countable PCR against qPCR and digital/droplet digital PCR on sensitivity, precision, dynamic range, multiplexing effort, analysis objectivity, and project cost, claiming roughly 10x better sensitivity and precision, 5x higher dynamic range, and 3x lower project cost than legacy methods; press coverage repeats a claim of being "at least 10 times" more sensitive than conventional PCR. Its entry into minimal residual disease testing places it near a competitive diagnostics segment that includes Natera and Guardant Health, and follows Foundation Medicine's $595m acquisition of Saga Diagnostics in April 2026; GlobalData projects the cancer diagnostics sector at $3.1bn in 2030.

The stated differentiators are true single-molecule counting rather than Ct-based or Poisson-estimated quantification, approximately 30 million compartments versus roughly 20-30k in droplet digital PCR, no sample loss or dead volume, instant multiplexing without custom probes or signal balancing, automated and objective analysis without manual thresholding, and audit-ready software supporting GMP workflows.

Technology

Countable PCR isolates single template molecules by centrifugation into a gel matrix, forming roughly 30 million compartments in a 50 µL reaction with 0% dead volume, and reads them with laser lightsheet 3D imaging. Quantification is by direct counting with fully automated analysis, producing CSV and HTML reports plus a per-channel ID quality score. Specified performance includes a 6-log dynamic range (1 to 1,000,000 molecules), limit of detection as low as 0.004% mutant allele frequency, sub-1% CV, up to 4 fluorescence channels (FAM/Alexa488/Atto488, HEX/VIC/Atto532, TEX615/Atto590, Cy5/Atto647N), amplicons up to 5 kb, inputs of 1-35 µL, 96 reactions per run at 40 seconds scan time per reaction, and software features supporting 21 CFR Part 11 compliance. Universal Multiplexing chemistry uses standard primers instead of custom probes; published work referenced by the company describes incorporating 10 fluorescent dyes using a 4-color optical setup. Compatible sample types include cell-free, tissue, FFPE, genomic and viral DNA, RNA, cDNA, plasmids and crude cell lysate.

Go-to-market

Direct commercial sales supported by demo requests, specialist consultations, an online product catalog with ordering, published white papers, application notes and blog resources, plus assay services. Global commercial expansion is led by a Vice President of Global Sales appointed in 2026, with the 2026 financing earmarked for developing and marketing products for key customer segments such as cell and gene therapy and MRD.

Scientists and laboratories in biomarker analysis, gene therapeutics, and clinical diagnostics, including cell and gene therapy developers and CROs, oncology and MRD testing labs, vaccine quality control, infectious disease and prenatal screening research, and labs performing orthogonal validation or lab-developed tests. Named users or commenters include LabCorp, the University of Georgia, and CGT CRO Carrigent.

Geography

Headquartered at 1810 Embarcadero Rd., Suite 200, Palo Alto, California 94303, with stated plans for global commercialization and expansion, including a European CE mark for its platform.

History

The company previously operated as Enumerix, and its technology was previously called UltraPCR; both names appear in earlier publications. Publications associated with the technology date to 2020 (PNAS), 2022 (ACS) and 2023 (bioRxiv). The site states the founding team pioneered DNA microarrays, non-invasive prenatal screening, high-throughput single-cell NGS, and spatial genomics and collectively holds over 60 granted patents.

Risks & controversies

All Countable Labs products are designated Research Use Only and not for use in diagnostic procedures, which limits clinical deployment pending further regulatory steps, though a CE mark has been obtained for Countable 4. Comparative performance claims against qPCR and digital PCR originate from the company's own materials and are described as experiment-dependent. The MRD segment the company targets is described in press coverage as increasingly competitive, with well-capitalized incumbents.