Boston Cell Standards secures first FDA clearance for anatomic pathology controls.

US Food and Drug Administration (FDA) clearance introduces first immunohistochemistry IHControls panel for evaluating breast cancers.

Boston Cell Standards, a company standardising cancer diagnostic tissue testing with the first immunohistochemistry (IHC) laboratory reference standards, has received 510(k) clearance from the FDA 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 standardisation in the anatomic pathology lab, especially in detecting low oestrogen receptor-expressing tumours,” 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, 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 – 30%. 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.

“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.”

For more information, please visit http://bostoncellstandards.com/.

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