Boston Cell Standards, Inc. (BCS), a private company bringing modern Quality tools and practices to Clinical Immunohistochemistry (IHC) testing worldwide, announced today that its IHC Reference Materials (IRMs) have entered the Qualification Phase of the Medical Device Development Tools (MDDT) Program of the U.S. Food and Drug Administration (FDA). The company believes that this regulatory milestone represents an important step toward establishing standardized reference materials that can support reproducible assay development across the IHC diagnostics industry, helping manufacturers and regulators achieve consistent, reliable measurements.
Entry into the MDDT 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. BCS initially proposed use of its IRMs in the context of stability testing and will now complete head-to-head studies comparing its IRMs with conventional tissue sections. Once qualified by the FDA, the BCS platform could be used by manufacturers to standardize performance measurements and generate data for regulatory submissions without needing validation of the technology itself during the approval process. This could result in multiple benefits to the life science industry, most notably in reduction of regulatory uncertainty, more consistent controls across clinical trial sites, and potential shortening of cancer therapeutic development timelines.
“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, MD, PhD, CEO 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.”
Platform Brings Modern Quality Practices and Standards to Cancer Testing
IHC assays guide treatment decisions for millions of cancer patients each year 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, contributing to published error rates between 10 and 30%.
Boston Cell Standards’ proprietary platform addresses this challenge by providing calibrated test materials with defined biomarker concentrations, bringing the modern quality techniques of Calibration and Statistical Process Control (SPC) to IHC lab testing. The company’s innovations integrate these materials with digital pathology imaging and image analysis software to enable standardized, quantitative assay performance assessment, aiming to significantly improve testing accuracy within and between laboratory facilities.
This project has been funded in whole or in part with Federal funds from the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N91024C00087. Development of the IRM 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 this pressing clinical laboratory testing need over more than 20 years.
About the U.S. FDA MDDT Program
The FDA’s MDDT program is intended to facilitate device development and promote innovation by providing a more efficient and predictable means of collecting information to support regulatory submissions. The qualification process consists of two phases: The Proposal Phase, to determine if the MDDT is suitable for qualification and to identify the performance criteria to be used to assess qualification, and the Qualification Phase, to determine whether the tool is qualified based on the evidence and justifications provided. MDDT qualification is a conclusion that within the stated context of use, the results of an assessment that uses an MDDT can be relied upon in device evaluation and to support regulatory decision-making.
About Boston Cell Standards
Boston Cell Standards (BCS) is a privately held diagnostics company dedicated to improving cancer patients’ lives by developing the first standardized reference materials and analytical tools to improve the accuracy and reproducibility of immunohistochemistry (IHC) testing used in cancer diagnosis and treatment. In late 2022, the U.S. FDA granted the company 510(k) clearance for its IHControls® panel (HER2/ER/PR) for evaluating certain breast cancers, representing a first-in-category regulatory approval. BCS is conducting additional clinical studies of its platform at laboratories worldwide to support potential expanded usage of its innovations. For more information, please visit: https://bostoncellstandards.com/
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