Fig. 3. Responsibilities and cooperation between the laboratory and the physician with respect to TP53 mutation diagnostics and interpretation.

The laboratory is responsible for issuing the correct result and reports all pathogenic TP53 variants above the validated LoD. The result should be interpreted in the context of tumor cell content, separation method, and disease status. The physician decides about the treatment based on all available information: the laboratory results, the clinical characteristics of the patient, patient preferences, and the availability of the treatment.