Study Establishes Boston Cell Standards’ Calibrated IHC Technology for Companion Diagnostic Immunohistochemistry

Accompanying editorial highlights potential impact of newly developed technology on patient care

BOSTON--(BUSINESS WIRE)--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.

The study, “Quantitative comparison of PD-L1 IHC assays against NIST standard reference material 1934,” published in the March issue of Modern Pathology, demonstrates the clinical impact and opportunity for incorporating calibrators with units of measure traceable to a National Institute of Standards & Technology (NIST) standard reference.¹

Companion diagnostic immunohistochemistry (IHC) tests do not yet incorporate the tools and principles of laboratory metrology. Basic analytic assay parameters, such as lower limit of detection (LOD) and dynamic range, are unknown in IHC. Boston Cell Standards solved this deficiency by developing completely new IHC calibrators with units of measure traceable to an objective, quantitative standard, NIST Standard Reference Material (SRM) 1934.

The study surveyed the standard PD-L1 assay results of 41 laboratories in North America and Europe with Boston Cell Standards’ newly developed Calibrated IHC (cIHC) technology. The study findings explained why some patients’ tissue samples were positive by one assay and negative by another. Also, the study quantified the sometimes-striking differences among FDA-cleared PD-L1 IHC assays.

PD-L1 is a protein biomarker whose presence in a patient biopsy influences whether oncologists prescribe anti-cancer drugs known as immune checkpoint inhibitors. The study analyzed both FDA-cleared and laboratory-developed tests (LDTs).

In the accompanying editorial, Drs. Sandra Martinez-Morilla, Myrto Moutafi, and David L. Rimm write that the study’s authors “produced a NIST-standardized calibrator tool that can solve the biochemical aspects of the variability of the PD-L1 assays, and its incorporation into IHC labs is likely to increase the chances that the right patients get the right drugs,” noting that cIHC “has the potential to change practice in pathology labs across the world.”

“The introduction of immunohistochemistry assay calibration solves an important challenge in companion diagnostic testing,” said Dr. Steve Bogen, CEO of Boston Cell Standards and a board-certified clinical pathologist. “The new ability to quantitatively calibrate an immunohistochemical assay dramatically simplifies companion diagnostic assay development and maintenance.”

About Boston Cell Standards

Boston Cell Standards is the first and only company to develop and manufacture standardized 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, please visit http://bostoncellstandards.com/.

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¹ Sompuram et al. (2022). “Quantitative comparison of PD-L1 IHC assays against NIST standard reference material 1934.” Modern Pathology, 35, 326-332.