Boston Cell Standards Enters Final Phase of FDA MDDT Program to Qualify First-in-Industry Platform to Standardize Cancer Diagnostic Assays
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.
