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Boston Cell Standards Gains 510(k) Clearance for Breast Cancer Test Control Panels

NEW YORK — Boston Cell Standards said Thursday it had gained US Food and Drug Administration 510(k) clearance for its IHControls panel to improve slide quality control for immunohistochemistry assays used to evaluate breast cancers.

The Boston-based biotech firm said its panel provides laboratory reference standards for immunohistochemistry testing and could help reduce discrepancy rates that can range from 10 percent to 30 percent. It said the clearance is a first-in-category regulatory approval, giving anatomic pathologists reproduceable and cost-effective on-slide quality control to reduce incorrect results and increase physician confidence in diagnoses and treatment selection.

"Any variation in the IHC reagents, instrument, or protocol can affect the test result," the company said. "IHControls detect these perturbations in a highly sensitive manner because, for the first time, the control concentration is consistently matched to the assay."

Boston Cell Standards CEO Steve Bogen said the company's quantitative approach to calibrators and controls will improve testing and reduce laboratory costs.