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Articles from Boston Cell Standards

Boston Cell Standards: Calibration Transforms Accuracy in HER2-Low Breast Cancer Testing
Boston Cell Standards today announced the publication of the CASI-01 study in Lancet: eBioMedicine demonstrating that calibration dramatically improves the accuracy and reproducibility of Immunohistochemistry (IHC) testing in breast cancer. Study authors concluded that the findings point to “pivotal advancements in precision medicine,” with potential far-reaching implications for HER2-low diagnosis, companion diagnostic development, regulatory reform for IHC clinical testing, and improved patient outcomes.
By Boston Cell Standards · Via Business Wire · November 19, 2025
ADDING MULTIMEDIA Visiopharm and Boston Cell Standards Announce Partnership to Develop Joint IHC Technology for Magnani-Taylor Regulatory Proposal
Visiopharm and Boston Cell Standards today announced a partnership to develop a joint technology solution that enables labs to meet key provisions of regulatory changes proposed in a groundbreaking editorial recently published in Archives of Pathology & Laboratory Medicine.
By Boston Cell Standards · Via Business Wire · August 15, 2023
Boston Cell Standards Wins First-Ever FDA 510(k) Clearance for Anatomic Pathology Controls
Boston Cell Standards, a company standardizing cancer diagnostic tissue testing with the first immunohistochemistry (IHC) laboratory reference standards, today announced it received 510(k) clearance from the U.S. Food & Drug Administration for its IHControls® panel (HER2/ER/PR) for evaluating breast cancers. This clearance represents a first-in-category regulatory approval.
By Boston Cell Standards · Via Business Wire · October 6, 2022
Publication Describes New International Consortium Standardizing Immunohistochemistry
Boston Cell Standards, a company standardizing tumor tissue testing with the first immunohistochemistry laboratory reference standards, announced the publication of a journal article summarizing the vital mission of the newly launched Consortium for Analytic Standardization in Immunohistochemistry (CASI).
By Boston Cell Standards · Via Business Wire · September 21, 2022
Study Establishes Boston Cell Standards’ Calibrated IHC Technology for Companion Diagnostic Immunohistochemistry
Boston Cell Standards, a company dedicated to ensuring that cancer patients receive accurate diagnosis and treatment, today announced the publication of a study and accompanying editorial in the peer-reviewed journal Modern Pathology, evaluating its Calibrated IHC (cIHC) technology in ensuring accuracy for companion diagnostic testing.
By Boston Cell Standards · Via Business Wire · April 7, 2022