It was approved by the FDA on 11 August 2020 for two purposes: (i) as a comprehensive genomic profiling in patients with any solid malignancy, and (ii) as a companion diagnostic to identify NSCLC patients with EGFR alterations who may benefit from treatment with osimertinib, based on the evidence of two phase II clinical trials: AURA3 [61] and FLAURA [62,63]. The gene discussed is EGFR; the disease is non-small cell lung carcinoma.