BOSTON, Mass. — Boston Cell Standards Inc. has entered the final qualification phase of a U.S. Food and Drug Administration program aimed at validating tools that support medical device development, marking a key step toward standardizing cancer diagnostic testing.
The private company said its immunohistochemistry reference materials have advanced into the Qualification Phase of the FDA’s Medical Device Development Tools program, a milestone that could pave the way for more consistent and reproducible cancer diagnostic assays.
Entry into the phase means the FDA has reviewed the proposed technology, agreed on its intended use, and approved a plan to generate the data needed for qualification. The company will now conduct comparative studies evaluating its materials against conventional tissue samples.
If ultimately qualified, the platform could allow manufacturers to use the reference materials to standardize testing performance and generate data for regulatory submissions without needing to revalidate the technology each time. That could reduce regulatory uncertainty, improve consistency across clinical trial sites, and potentially shorten development timelines for cancer therapies.
“Throughout development of our platform, we have been working closely with the FDA to demonstrate how calibrated reference materials could be used in defined regulatory contexts,” said Steve Bogen, M.D., Ph.D., chief executive officer of Boston Cell Standards. “We believe that successful completion of the FDA’s MDDT program would not only represent an important step toward establishing objective, reproducible standards for IHC assay performance, but could ultimately elevate cancer patient care.”
Immunohistochemistry assays are widely used to guide treatment decisions for cancer patients by measuring biomarkers that determine eligibility for targeted therapies. However, traditional validation methods often rely on patient tissue samples with variable biomarker levels, contributing to reported error rates of 10% to 30%.
Boston Cell Standards’ platform aims to address those challenges by introducing calibrated materials with defined biomarker concentrations, along with digital pathology tools and analytical software. The approach is designed to bring standardized measurement and quality control practices to laboratory testing.
The effort has received funding support from the National Cancer Institute, part of the National Institutes of Health, including a recent two-year contract valued at nearly $2 million. In total, the agency has provided more than $9 million over the past two decades to support development of the platform.
