The US Food and Drug Administration (FDA) has granted 510(k) clearance for Boston Cell Standards’ IHControls panel (HER2/ER/PR) to evaluate breast cancers.
The IHControls panel is claimed to be the first truly quantitative linear range controls designed for immunohistochemistry (IHC) laboratories.
Boston Cell Standards stated that the FDA approval marks the first regulatory approval in this category.
For anatomic pathologists, the panel offers a reproducible, cost-effective and accurate solution for on-slide quality control.
IHC tests can support the diagnosis of cancer as well as help with treatment decisions, however, there is a lack of analytic reference standards to ensure that all tests are aligned with one another.
Due to the lack of IHC reference standards, different laboratories can return different results from the same sample.
Boston Cell Standards has developed the first and only IHC reference materials, which include linear range on-slide controls (IHControls) and calibrators (IHCalibrators).
IHControls are designed to verify the accuracy of IHC assays, ensuring all IHC tests are performed correctly on all patient samples.
Additionally, any variation in the IHC reagents, instruments or protocols that could affect the test result, can be detected with high sensitivity as the control concentration is matched to the assay.
IHCalibrators provide units of measure traceable to objective and quantitative standards.
Boston Cell Standards CEO and board-certified clinical pathologist Dr Steve Bogen said: “There is a clear precedent for synthetic controls in other disciplines of pathology, particularly in clinical chemistry.
“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.”