34. The report must state the test scope and assay limitations, and refer the patient elsewhere for further testing/analysis of additional genes implicated in HBOC as appropriate, should the analytical and/or clinical sensitivity fail to reach the required laboratory-determined threshold/standard. 35. For TP53 variants fitting the criteria for consideration of CHIP/mosaicism (see Section 5.3), reports must clearly state the risk of CHIP if further work is not performed, or CHIP has been experimentally excluded/confirmed. |