The company’s immunohistochemistry reference materials entered the qualification phase of the Medical Device Development Tools program.
Boston Cell Standards Inc announced that its immunohistochemistry reference materials have entered the qualification phase of the Medical Device Development Tools (MDDT) program of the Food and Drug Administration (FDA).
The milestone represents a step toward establishing standardized reference materials to support reproducible assay development across the immunohistochemistry diagnostics industry. Entry into the qualification phase indicates that the FDA has reviewed the proposed technology, deemed its context of use appropriate, and agreed on a plan for generating qualification data.
Boston Cell Standards will now complete head-to-head studies comparing its immunohistochemistry reference materials with conventional tissue sections. Once qualified by the FDA, manufacturers could use the platform to standardize performance measurements and generate data for regulatory submissions without needing to validate the technology itself during the approval process. This may reduce regulatory uncertainty, provide more consistent controls across clinical trial sites, and potentially shorten development timelines for cancer therapeutics.
“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,” says Steve Bogen, MD, PhD, chief executive officer of Boston Cell Standards, in a release. “We believe that successful completion of the FDA’s MDDT program would not only represent an important step toward establishing objective, reproducible standards for immunohistochemistry assay performance, but could ultimately elevate cancer patient care.”
Standardizing Immunohistochemistry Assays
Immunohistochemistry assays guide treatment decisions for cancer patients by measuring tumor cell biomarkers that determine eligibility for targeted therapies. Historically, traditional assay validation has relied on testing random patient tissue samples that lack defined biomarker concentrations. The company says this contributes to published error rates between 10% and 30%.
The Boston Cell Standards platform addresses this challenge by providing calibrated test materials with defined biomarker concentrations. This approach brings quality techniques, such as calibration and statistical process control, to immunohistochemistry lab testing. The materials integrate with digital pathology imaging and image analysis software to enable standardized, quantitative assay performance assessment.
Project Funding and Development
This project has been funded in part with federal funds from the National Cancer Institute (NCI), National Institutes of Health, and the Department of Health and Human Services. Development of the immunohistochemistry reference materials platform and MDDT certification has been supported by a $1,995,119 two-year contract from the NCI. In total, the NCI has provided more than $9 million in funding grants to address clinical laboratory testing needs over more than 20 years.
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