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).

In the article, “A Consortium for Analytic Standardization in Immunohistochemistry^[i],” published online in the Archives of Pathology & Laboratory Medicine, an international panel of pathologists and leaders of laboratory accreditation agencies describe the new consortium for establishing industrywide immunohistochemistry (IHC) reference standards to improve test accuracy and reproducibility.

CASI is initially funded by a $2 million grant from the National Cancer Institute. Its 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.

Clinical laboratory practices in IHC differ from practices in other types of hospital laboratories, such as the blood testing laboratory. 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 can – 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 to 30 percent.^[ii]

“The absence of analytic standards is a highly unusual situation for a clinical diagnostic testing environment,” according to the manuscript. “There is no precedent to our knowledge for an entire clinical laboratory testing industry to lack analytic standards, especially one so large, well established, and critically important for patient care as IHC.”

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.

“Physicians rely on IHC companion diagnostic results to inform diagnosis and treatment decisions for their cancer patients. However, without reference standards, pathologists lack the necessary tools to ensure accurate, consistent results,” said Dr. Keith Miller, FIBMS, former director of the UK National External Quality Assessment Scheme for Immunohistochemistry & In-situ Hybridisation, a CASI steering committee member. “CASI was formed to fill this critical void in surgical pathology by establishing the standards and controls that make more reliable test results possible.”

“CASI’s technical mission – to identify objective, quantifiable analytic sensitivity guidelines for IHC assays – has an important patient impact,” said Dr. Steve Bogen, CEO of Boston Cell Standards and a board-certified clinical pathologist. “The standards of clinical laboratory practice that CASI creates stand to provide oncologists greater confidence in diagnosing patients and selecting the proper course of treatment, reduce the need for re-testing in laboratories, and inform accurate patient selection during clinical trials.”

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.

About Boston Cell Standards

Boston Cell Standards is the first and only company to develop and manufacture quantitative 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. The company brings 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 http://bostoncellstandards.com/.

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^[i] SA Bogen, et al. A consortium for analytic standardization in immunohistochemistry. Arch Pathol Lab Med TBD, TBD (2022)

^[ii] Bogen S. A root cause analysis into the high error rate for clinical immunohistochemistry. Appl Immunohistochem Mol Morphol 27, 329-338 (2019)

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