Driving Global Diagnostic Accuracy for Biomarker Quantification in a Female-Specific Cancer
The challenge
A global top 20 pharmaceutical company gained approval for a new antibody-drug conjugate for the treatment of metastatic cancer. However, launch success hinged on precise biomarker quantification through immunohistochemistry, a process that was not yet standardized for this novel target. Diaceutics was engaged to support a change in established practice and strengthen the market’s diagnostic capability to detect and quantify the biomarker.
Traditional testing focused on distinguishing positive from negative cases. This created a challenge for pathologists in consistently identifying and reporting patients potentially eligible for the new therapy.
Training Gaps: Limited training and guidance for pathologists in the new biomarker category led to inconsistent results.
Diagnostic Variability: IHC scoring varied significantly among pathologists globally, particularly at the critical threshold.
Clinical Impact: Inaccurate classification could result in missed treatment opportunities for patients who might benefit from this therapy. .
Our Approach
Using the Diaceutics Lab Network and internal expertise, Diaceutics facilitated a global, real-world scientific study to assess and improve the accuracy of biomarker quantification. The study used digitized cancer tissue images representing the full spectrum of expression.
Key elements of our support included:
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Pragmatic study design: Leveraging Diaceutics’ real-world diagnostic knowledge and in-market expertise, two widely adopted assays to benchmark baseline assessment accuracy.
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Timely study recruitment: The study recruited 77 pathologists from 14 countries to provide a broad, real-world assessment of diagnostic performance.
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Virtual Training Program: Diaceutics experts facilitated a focused training program. The results were assessed against the client’s strategic launch plan to identify actionable tactics support launch.
The Impact
The collaboration delivered the following measurable outcomes:
Improved Accuracy: Baseline agreement rates for scoring with a selected antibody were >80% but <90%. After training, negative percentage agreement improved from 80.6% to 91.1% for this assay.
Global Benchmark: The study generated scientific evidence showing that while the targeted biomarker’s diagnostic accuracy was within an acceptable range, variability persisted across labs. This benchmark helped define a new standard for proficiency and identified actionable opportunities to improve real-world testing quality.
Optimized Strategy: The study revealed specific challenges in accurately distinguishing HER2-0 from HER2-low, with both underscoring and overscoring observed across labs. While training improved scoring accuracy, the findings highlighted a broader need for standardization. These insights directly informed and refined the launch strategy, allowing tactical plans to address the real-world diagnostic complexity.
By showing where scoring accuracy could be improved, the study helped strengthen the diagnostic pathway for identifying patients who may be eligible for therapy. It also identified the aspects of the testing process where further standardization and support were needed.
About Diaceutics
For more than 20 years, we have helped biopharma companies overcome the diagnostic and commercialization barriers that stand between scientific innovation and patient impact. Today, we combine diagnostic intelligence, expert insight and targeted engagement to unlock the full potential of diagnostic-driven therapies—and more life for the patients they are designed to serve.
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