Boston Cell Standards Advances in FDA MDDT Program for Cancer Diagnostic Assays
Boston Cell Standards, Inc. has announced that its IHC Reference Materials (IRMs) have entered the Qualification Phase of the FDA’s Medical Device Development Tools (MDDT) Program, marking a significant step towards standardizing cancer diagnostic assays.
BOSTON–(BUSINESS WIRE)– #cancerdiagnostics–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