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Survey assesses impact of anti-ER antibody recall on immunohistochemistry accuracy in breast cancer.
Accurate estrogen receptor (ER) immunohistochemistry (IHC) is essential for therapeutic decision-making in breast cancer. Monash Medical Centre reports >1500 breast core biopsies (≈75% requiring ER testing) and >650 breast excisions annually (>90% requiring ER testing). In September 2025, the TGA issued a Class II recall for multiple lots of the CONFIRM anti-ER (SP1) rabbit monoclonal antibody due to unacceptable light staining, posing a risk of false-negative or low-positive ER results in weakly staining tumours.
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Thayaparan et al. (2026) studied this question.
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