Abstract
Immunohistochemistry is the most common method for companion diagnostic testing in breast cancer. The readings for estrogen receptor, progesterone receptor, and Her2 directly affect prescription of critical therapies. However, immunohistochemistry is highly sensitive to innumerable pre-analytic variables that result in loss of signal in these assays. Perhaps the most significant pre-analytic variable is cold ischemic time. The work of Pinhel and colleagues in the previous issue of Breast Cancer Research examines the effects of cold ischemic time and finds a chilling result. The authors show that while the classic markers may be only mildly affected, phospho-specific markers are highly sensitive to this artifact. As a result, it is likely that future companion diagnostic tests that include phospho-specific epitopes will be reliably done only in core needle biopsies that minimize ischemic time.
Highlights
Immunohistochemistry is the most common method for companion diagnostic testing in breast cancer
Thousands of uncontrolled variables that affect every tissue specimen could alter the results of companion diagnostic testing
In the previous issue of Breast Cancer Research, Pinhel and colleagues [1] examined the effects of time to fixation by the measurement of protein expression of traditional breast cancer biomarkers in a timed series of core needle biopsies and the conventional resection specimens
Summary
Immunohistochemistry is the most common method for companion diagnostic testing in breast cancer. The quality of the tissue is dramatically affected by pre-analytic variables. Thousands of uncontrolled variables that affect every tissue specimen could alter the results of companion diagnostic testing.
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