Boston Cell Standards Wins First-Ever FDA 510(k) Clearance for Anatomic Pathology Controls

BOSTON--(BUSINESS WIRE)-- Boston Cell Standards, a company standardizing cancer diagnostic tissue testing with the first immunohistochemistry (IHC) laboratory reference standards, today announced it received 510(k) clearance from the U.S. Food & Drug Administration for its IHControls^® panel (HER2/ER/PR) for evaluating breast cancers. This clearance represents a first-in-category regulatory approval.

IHControls are the first truly quantitative linear range controls for IHC labs. This panel provides anatomic pathologists a reproducible, cost-effective solution for on-slide quality control, to safeguard against the potential for incorrect results and increase physician confidence in making diagnoses and selecting treatments.

“IHControls represent a giant step forward in standardization in the anatomic pathology lab, especially in detecting low estrogen receptor-expressing tumors,” said Dr. Matthias Szabolcs, Director, Immunohistochemistry Laboratory, at Columbia University Medical Center/New York-Presbyterian Hospital. “Today, we can establish which patients will not benefit from an immunotherapy, but not how well they will respond to another treatment. IHControls may give anatomic pathologists the ability to increase positive predictive value, allowing us to determine which patients will benefit, and by how much.”

Immunohistochemistry (IHC), a category of tests that informs diagnosis and treatment decisions in cancer, lacks analytic reference standards that ensure all tests are aligned with one another. Without IHC reference standards, 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.¹ To address this deficiency, Boston Cell Standards invented the first and only IHC reference materials, including linear range on-slide controls (IHControls^®) for verification of IHC assay accuracy and calibrators (IHCalibrators^®) with units of measure traceable to objective, quantitative standards.

IHControls^® ensure that all IHC tests, on all patient samples, are performed correctly. Any variation in the IHC reagents, instrument, or protocol can affect the test result. IHControls^® detect these perturbations in a highly sensitive manner because, for the first time, the control concentration is consistently matched to the assay. The sensitivity, specificity, reproducibility, stability, and real-world performance of IHControls^® has been validated and published.^2,3,4

“There is a clear precedent for synthetic controls in other disciplines of pathology, particularly in clinical chemistry,” added Dr. Steve Bogen, CEO of Boston Cell Standards and a board-certified clinical pathologist. “We expect this quantitative approach to calibrators and controls – specifically, the first linear range controls on the market – to improve quality and reduce laboratory costs compared with other controls.”

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/.

¹ Bogen S. A root cause analysis into the high error rate for clinical immunohistochemistry. Appl Immunohistochem Mol Morphol 27, 329-338 (2019)
² SR Sompuram, et. al. Quantitative assessment of immunohistochemistry laboratory performance by measuring analytic response curves and limits of detection. Arch. Pathol. Lab. Med. 2018 142(7):851-862.
³ K Vani, et. al. The importance of epitope density in selecting a sensitive positive IHC control. .J. Histochem. Cytochem. 2017 65(8):463-477.
⁴ SR Sompuram, et. al. Selecting an optimal positive IHC control for verifying antigen retrieval. J. Histochem. Cytochem. 2019 67(4):275-289.

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