Landmark Study by Boston Cell Standards Validates First Reference Standards for Immunohistochemistry Testing

BOSTON, March 04, 2021 (GLOBE NEWSWIRE) -- Boston Cell Standards announced the publication this month of a Canadian national study testing the first reference standard for estrogen receptor (ER) immunohistochemistry (IHC) testing. The results appeared in February in the journal Clinical Chemistry.

ER testing is important for optimal breast cancer treatment but test results sometimes vary among laboratories. In this newly published study of 53 laboratories, the data showed that the ER reference standard can prevent this variability by quickly identifying outlier laboratories. Boston Cell Standards believes that the availability of an ER reference standard will lead to the standardization of ER testing worldwide, ensuring consistent patient test results.

The creation and validation of the ER reference standard was a collaboration of the Canadian Immunohistochemistry Quality Control (CIQC) program, the National Institute of Standards and Technology, and Boston Cell Standards Inc. CIQC offered Canadian ER testing laboratories the opportunity to test 80 different breast cancer patient samples, as a way to verify that they obtain the correct test result. The new ER reference materials were also included. Laboratory performance with the new ER reference standard correlated with each laboratory’s ability to accurately distinguish positive and negative patient samples.

Variability in ER testing is more problematic among low or moderately ER-positive samples. These types of (low positive) cases were the subject of recently issued guidelines, i.e., the May 2020 revision to the “ASCO/CAP Guideline Recommendations for Immunohistochemical (IHC) Testing of Estrogen and Progesterone Receptors (ER/PgR) in Breast Cancer.” Boston Cell Standards believes the new ER reference materials will assist laboratories in adhering to the revised guidelines.

Dr. Steven Bogen, CEO of Boston Cell Standards, which developed the reference standard, said, “The study data validate our efforts to introduce the same systems of quality assurance to anatomic pathology testing, including reference standards, as already exist in clinical pathology. We expect that standardized testing will lead to significant improvements in immunohistochemistry test accuracy and reproducibility.”

About Boston Cell Standards

Boston Cell Standards is the first and only company to develop and manufacture standardized reference materials in the immunohistochemistry industry. Its mission is to improve patient outcomes by ensuring that immunohistochemistry test results are accurate and reproducible regardless of where or when tests are performed. Laboratory reference materials are essential for that purpose. We bring together outstanding physicians, scientists, and staff in a creative and supportive environment with the goal of spurring groundbreaking advances that can be applied to the laboratory setting. For more information, visit


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