Boston Cell Standards has announced that its Immunohistochemistry (IHC) Reference Materials (IRMs) have entered the qualification phase of the Medical Device Development Tools (MDDT) Programme of the U.S. Food and Drug Administration. The milestone marks a significant step toward improving standardisation and reproducibility in cancer diagnostic testing.

The advancement follows regulatory review of the company’s proposed technology and its intended use, with the FDA agreeing on a framework for generating qualification data. As part of the next phase, Boston Cell Standards will conduct comparative studies between its IRMs and conventional tissue samples to validate performance.

If successfully qualified, the platform could enable manufacturers and researchers to use standardised reference materials in clinical trials and regulatory submissions without requiring repeated validation. This is expected to reduce regulatory uncertainty, enhance consistency across testing sites, and potentially shorten timelines for cancer therapy development.

Immunohistochemistry assays play a critical role in cancer care by identifying tumour biomarkers that guide treatment decisions. However, traditional validation methods rely on variable patient tissue samples, contributing to inconsistencies and error rates. Boston Cell Standards’ approach introduces calibrated reference materials with defined biomarker concentrations, enabling more precise and reliable testing outcomes.

The company’s platform integrates these materials with digital pathology and analytical tools, applying modern quality practices such as calibration and statistical process control to improve accuracy across laboratories.

The development of the IRM platform has been supported by funding from the National Cancer Institute, part of the National Institutes of Health, reflecting long-term efforts to enhance clinical laboratory standards.

The FDA’s MDDT programme is designed to encourage innovation by providing a structured pathway for tools that support medical device development and regulatory evaluation. Entry into the qualification phase signals growing confidence in the potential of Boston Cell Standards’ technology to transform diagnostic consistency in oncology.