Acuamark shares peer-reviewed blood test results for early colorectal cancer

Acuamark Diagnostics announced two peer-reviewed studies on a sequencing-free blood test for colorectal cancer on August 27, 2026, highlighting 92% sensitivity at 97% specificity in a validation subset that included Stage I-IV disease. The company says the PCR-based approach could make methylation testing more accessible to labs already using standard molecular diagnostic tools.

Why it matters: - Colorectal cancer screening works best when disease is found early, and Acuamark’s data suggest a blood test could detect Stage I and II disease without sequencing. - A PCR-based workflow could lower technical barriers for clinical labs that already run qPCR or dPCR. - Acuamark’s assays remain investigational and are not approved for clinical use.

What happened: - Acuamark Diagnostics announced two peer-reviewed publications on August 27, 2026, describing its sequencing-free cfDNA methylation platform for colorectal cancer detection. - The clinical study appeared in Cancer Prevention Research. - The companion methods paper appeared in the Journal of Personalized Medicine. - The company said the work covers development and initial clinical evaluation of its blood-based colorectal cancer assay, including early-stage disease.

The details: - The Cancer Prevention Research study tested plasma from 216 participants, including 86 people with colorectal cancer and 130 healthy controls. - Researchers used a 40-marker methylation panel read on qPCR. - The 216 samples were split into a 151-sample training subset and a separate 65-sample validation subset. - In the validation subset, which included Stage I-IV colorectal cancer cases, the top-performing neural-network models reached 92% sensitivity at 97% specificity. - Across 14 models, validation sensitivity ranged from 81% to 92% and specificity ranged from 85% to 97%. - The early-stage validation subset included 11 cases with Stage I or II disease. - Sensitivity for Stage I and II cases ranged from 90.9% to 100% across the four top-performing models. - The authors noted the early-stage sample size was limited and said larger cohorts are needed to confirm those results. - Cumulative methylation signals rose from healthy controls through advancing colorectal cancer stages, supporting the marker set used by the assay. - The study did not evaluate detection of advanced adenomas. - Acuamark said it is preparing a larger clinical verification study that will include advanced adenoma evaluation. - The Journal of Personalized Medicine paper described a multiplexed qPCR-based cfDNA methylation assay using enzymatic conversion. - The workflow avoids conventional bisulfite treatment, which can degrade small amounts of fragmented cfDNA in blood. - The assay targets 40 CpG methylation markers associated with colorectal cancer. - The platform is compatible with both qPCR and dPCR. - Analytical testing showed detection of methylated DNA below 0.2%. - qPCR and dPCR produced concordant results. - The PCR-based workflow does not require sequencing, sequencing-library preparation or extensive bioinformatic processing. - The company said the approach could make methylation-based liquid biopsy testing more accessible to laboratories with standard molecular diagnostic equipment. - Acuamark’s lead colorectal cancer program is built to run on widely available, high-throughput laboratory instrumentation. - The platform is being developed for transfer to clinical laboratory systems and future distributed-kit deployment. - The company said its assays are protected by an exclusively licensed, multi-layer patent estate.

Between the lines: - The strongest signal in the announcement is not just detection, but detection without next-generation sequencing. - That matters because standard PCR workflows are already common in clinical labs, which could make adoption easier if the results hold up in larger studies. - The data are promising, but the validation set was still small, especially for early-stage disease. - The company is positioning the platform as a practical screening tool, not just a research assay.

What's next: - Acuamark said it is moving toward a larger clinical study. - The next study will also assess advanced adenoma detection. - The company said it is preparing for commercialization alongside further clinical evaluation. - The release included forward-looking statements about development, regulatory advancement and potential commercialization, along with risks tied to validation, approval and financing.

The bottom line: - Acuamark has published early evidence that a sequencing-free PCR blood test may detect colorectal cancer, including early-stage disease, with strong performance in a limited validation set.