BOSTON–(BUSINESS WIRE)–Boston Cell Standards, a company that standardizes tumor tissue testing with premier immunohistochemistry laboratory reference standards, announced the publication of an article summarizing the vital mission of the newly formed Consortium for Analytical Standardization in Immunohistochemistry (CASI).
In the article, “A Consortium for Analytical Standardization in Immunohistochemistry[i]”, published online in the Archives of pathology and laboratory medicine, an international panel of pathologists and leaders of laboratory accreditation agencies describe the new consortium for establishing industry-wide immunohistochemistry (IHC) reference standards to improve accuracy and test reproducibility.
CASI is initially funded by a $2 million grant from the National Cancer Institute. Its mission is to integrate analytical reference standards into IHC, a test format widely used in surgical pathology to assess cancers in tissue samples and determine appropriate treatment.
Clinical laboratory practices in CSI differ from practices in other types of hospital laboratories, such as the blood laboratory. Standard patient blood tests can be analyzed in any laboratory and give the same results every time thanks to international reference standards that ensure that all tests are aligned with each other; the patient and the doctor can have confidence in the results wherever the tests are performed.
No such reference standard exists in the IHC, which means that different labs can – and often do – return different results from the same sample. Rates of clinically inadequate IHC tests are about 10 times higher than those of clinical blood test laboratories, with test discrepancy rates of 10-30%.[ii]
“The absence of analytical standards is a highly unusual situation for a clinical diagnostic testing environment,” according to the manuscript. “There is no precedent that we know of for an entire clinical laboratory testing industry to lack analytical standards, especially one so large, well-established and critically important to patient care like IHC .”
CASI will conduct studies to determine appropriate analytical sensitivity thresholds for selected IHC assays, publish the data it collects, and then provide analytical sensitivity recommendations. In addition to guiding routine clinical practice, these recommendations will aim to facilitate and simplify the transfer of methodology between laboratories, from the published literature, and in clinical trials.
“Physicians rely on IHC’s companion diagnostic results to inform diagnostic and treatment decisions for their cancer patients. However, without gold standard, pathologists lack the tools to ensure accurate and consistent results,” said Dr Keith Miller, FIBMS, former director of the UK National External Quality Assessment Scheme for Immunohistochemistry & In-situ Hybridization, member of the CASI Steering Committee. . “CASI was created to fill this critical void in surgical pathology by establishing the standards and controls that lead to more reliable test results.”
“CASI’s technical mission – to identify objective, quantifiable analytical sensitivity guidelines for IHC testing – has a significant impact on patients,” said Dr. Steve Bogen, CEO of Boston Cell Standards and board-certified clinical pathologist. “The clinical laboratory practice standards created by ACMS are intended to give oncologists greater confidence in diagnosing patients and choosing the appropriate treatment, reducing the need for new laboratory tests, and informing the accurate selection of patients in clinical trials. »
Boston Cell Standards invented the first and only IHC reference materials, including calibrators for IHC normalization and controls for daily verification of IHC test accuracy. These tools incorporate concentration measurements traceable to a National Institute of Standards and Technology (NIST) standard.
About Boston Cellular 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 no matter where and when the tests are performed. Laboratory reference materials are essential for this purpose. The society brings together exceptional physicians, scientists, and personnel in a creative and supportive environment with the goal of stimulating breakthrough advances that can be applied in the laboratory. For more information, visit http://bostoncellstandards.com/.
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[i] SA Bogen, et al. A consortium for analytical standardization in immunohistochemistry. Arch Pathol Lab Med TBD, TBD (2022)
[ii] Bogen S. An analysis of the root causes of the high error rate for clinical immunohistochemistry. Appl Immunohistochem Mol Morphol 27, 329-338 (2019)
