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Consortium for Analytic Standardization in Immunohistochemistry

Group of renowned pathologists and scientists aims to improve patient immunohistochemistry (IHC) test accuracy

Boston Cell Standards

Our story began in 2003. One of the BCS founders, Dr. Steve Bogen, had just sold the Artisan® special stainer (histopathology) product line to Dako Corp. (now Agilent) and returned to academia as Medical Director of the clinical chemistry laboratory, Boston Medical Center. That transition highlighted the contrast in laboratory practice between tissue (histopathology) vs. blood (clinical chemistry) diagnostic testing. Basic quality systems in clinical chemistry, such as reference standards, measurement traceability, units of measure, and Levey-Jennings QC analysis, were unheard-of in immunohistochemistry (histopathology).

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Published:Mar 09, 2022
|2 min read
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BOSTON, MA — Boston Cell Standards, a company dedicated to ensuring that cancer patients receive accurate diagnosis and treatment, announced that it launched the Consortium for Analytic Standardization in Immunohistochemistry (CASI). The new organization is led by an international panel of pathologists and scientists dedicated to improving patient immunohistochemistry (IHC) test accuracy and reproducibility.

Initially funded by a $2 million grant from the National Cancer Institute, the consortium’s mission is to integrate analytic reference standards into IHC, a test format widely used in surgical pathology to evaluate cancers in tissue samples and determine correct treatment.

Standard patient blood tests can be analyzed in any lab and yield the same results every time because of international reference standards that ensure all tests are aligned with one another; both patient and physician can have confidence in the results wherever the tests are performed.

No such reference standards exist in IHC, meaning that different labs could—and often do—return different results from the same sample. Rates of clinically inadequate IHC testing are roughly 10 times that of clinical blood testing labs, with test discrepancy rates of 10 percent to 30 percent. Introducing reference standards will raise the quality of IHC testing by giving pathologists certainty that their results are accurate and oncologists greater confidence in patient diagnosis and treatment selection.

“Biopsy testing in the pathology lab with immunohistochemistry is essential to characterizing a patient’s cancer and determining the proper course of treatment. However, a lack of industry-wide standards, calibrators and controls, and traceable units of measure has, for years, frustrated attempts to lower the error rate. It holds the entire field of pathology back,” said Dr. Steve Bogen, CEO of Boston Cell Standards, a board-certified clinical pathologist. “Building analytic standards and integrating them into routine clinical practice and clinical research will provide pathologists and clinical research scientists vital tools to inform their best work.”

CASI will conduct studies to determine appropriate analytic sensitivity thresholds for selected IHC tests, publish the data it collects, and then offer analytic sensitivity recommendations. In addition to guiding routine clinical practice, these recommendations will be intended to facilitate and simplify methodology transfer between laboratories, from published literature, and in clinical trials.

“Harmonization among all IHC laboratories is an essential goal for improved patient care. The ability to set objective, quantitative lower limits of detection for any assay is a much-needed step in this direction,” said Dr. Emina Torlakovic, a board-certified anatomic and clinical pathologist and hematopathologist; director of Canadian Biomarker Quality Assurance academic program; division head of Hematopathology, Department of Pathology & Laboratory Medicine, Saskatchewan Health Authority and University of Saskatchewan; and, chairperson of the CASI steering committee. “The consortium’s work stands to make a valuable and lasting positive impact on labs, clinicians, and patients, and improve the delivery of care. I’m honored to be a part of it.”

Boston Cell Standards invented the first and only IHC reference materials, including calibrators for IHC standardization and controls for daily verification of IHC assay accuracy. These tools incorporate concentration measures that are traceable to a National Institute of Standards and Technology (NIST) standard.

 - This press release was provided by Boston Cell Standards