Cerca Biotech publishes white paper on Ki-67 testing in breast cancer

Cerca Biotech has released a new white paper on Ki-67 testing that positions MammaTyper® as a more reproducible and reliable option for breast cancer biomarker analysis. The document argues the RT-qPCR test can reduce variability tied to traditional IHC workflows and support more standardized clinical decisions.

Why it matters: - Ki-67 testing helps guide breast cancer prognosis and treatment stratification. - Traditional IHC testing can vary by pathologist judgment, hotspot selection and lab-to-lab performance. - Cerca Biotech is positioning MammaTyper® as a way to reduce ambiguity in breast cancer biomarker results.

What happened: - Cerca Biotech published a dedicated white paper on Ki-67 detection in breast cancer. - The paper focuses on MammaTyper® and its reproducibility and analytical reliability for Ki-67, ER, PR and HER2. - The release was issued in Berlin on July 16, 2026.

The details: - The white paper draws on multi-center international validation data and real-world laboratory performance evidence. - MammaTyper® uses RT-qPCR molecular detection. - The company says objective quantitative measurement removes human subjectivity linked to IHC and CISH detection. - The paper reports inter- and intra-laboratory reproducibility across Ki-67, ER, PR and HER2. - Categorical classification kappa coefficients are reported at 0.90 to 1.00. - The paper says MKI67 and other target genes produce stable quantitative readouts across laboratories, equipment and operators. - The paper cites high clinical concordance with reference standards, including optimized Ki-67 agreement rates and strong matching for ER, PR and HER2. - The document says MammaTyper® is compatible with multiple mainstream testing platforms. - The white paper says automated standardized reporting workflows reduce manual errors. - The release says the assay helps resolve equivocal biomarker results, lowers repeated retesting rates and supports unified implementation of clinical guidelines worldwide. - The full white paper is available for download for clinical laboratories, pathologists, oncologists and medical research institutions. - The release includes Cerca Biotech social links on LinkedIn and YouTube.

Between the lines: - The white paper is aimed at a persistent pain point in breast cancer diagnostics: inconsistent Ki-67 interpretation. - By emphasizing quantitative molecular testing, Cerca Biotech is making a broader case for moving some biomarker workflows away from subjective review. - The reproducibility claims are central to the product pitch because lab consistency can affect downstream treatment decisions.

What's next: - Clinical labs, pathologists, oncologists and research institutions can now download the white paper. - Cerca Biotech appears to be using the publication to support wider adoption of MammaTyper® in breast cancer biomarker testing. - The company is likely to continue citing peer-reviewed studies and validation data to back the assay's clinical use.