Boston Cell Standards Inc

Boston Cell Standards Inc develops calibration and quality control solutions for immunohistochemistry (IHC) testing, a critical diagnostic method in cancer diagnosis and treatment stratification. The company manufactures IHCalibrators® and IHControls®—quantitative reference standards and quality control products designed to standardize and improve the accuracy and consistency of IHC assays across laboratory systems and sites. BCS products are used in clinical pathology laboratories for assay validation, lot-to-lot and instrument-to-instrument alignment, troubleshooting, and proficiency testing, as well as in pharmaceutical and life sciences settings for drug development and clinical trial consistency. The company received FDA clearance for its IHControl® panel—the first FDA-cleared quantitative control for anatomic pathology in breast cancer—and collaborates with the National Institute of Standards and Technology (NIST) to establish measurement traceability and reference standards for IHC. Boston Cell Standards is ISO 13485 certified and has received over $9 million in funding from the National Cancer Institute (NIH) spanning more than 20 years. The company has established the Consortium for Analytic Standardization in Immunohistochemistry (CASI) to advance IHC quality standards. Research published in peer-reviewed journals including Lancet: eBioMedicine, Laboratory Investigation, and American Journal of Surgical Pathology validates the effectiveness of BCS technology in improving analytical sensitivity and reducing inter-lab variability in breast cancer HER2 testing and other oncologic diagnostics.