[16409465]
This case was unequivocally amplified for her2 gene by the fda approved vysis probe fish kit on the pt's original core biopsy, with a her2/cep17 ratio of 4. 41. The oncotype rt-pcr test/device, a laboratory-developed, multivariate index assay, reported a negative her2 result for this pt on the resection specimen, so we repeated the fish for her2 on the very same tissue block that the oncotype test used, and we found the fish ratio to be 2. 83. The false negative oncotype her2 result implies two potentially very serious harmful issues to the pt, who is a candidate for her2 targeted therapy according to the amplified fish result: it clouds the clinician's judgment about whether to give her2 therapy and raises serious questions about the robustness of the other 15 gene components of the oncotype test, and hence, the recurrence score, which is the core result of the oncotype test. If a clinician chooses not to treat this pt based on the oncotype her2 result, the standard of care will not be met, and litigation becomes a serious issue for this case.
Patient Sequence No: 1, Text Type: D, B5