Reviewer # 3:

This is an elderly female patient with a history of adenocarcinoma. Her oncologist ordered the Guardant 360 blood test.

Without question, the use of genetic marker receptor testing for adenocarcinoma of the lung is now the standard of care for every patient at diagnosis (1-2). It is used also to guide future therapies that have shown efficacy in those patients on receptor treatments that have progressed.

Standard receptors that would be evaluated include E6FR, T790M, ALK, ROS1 and others such as MET, BRAF, HER-2 neu, NTRK etc. these treatments have clearly improved survival, Q.L, PFS over use of the chemotherapy. Biopsy of tissue or liquid biopsies have been used to determine the type of receptor the patient has and thus institute specific targeted treatment.

This patient never had a tissue diagnosis to even establish a lung cancer. It was sent off with a presumed diagnosis of adenocarcinoma based on a relatively stable lung nodule over approximately a significant period of time on a Tarceva like drug.

The study identified no somatic mutation. Because the test was sent off without a cancer diagnosis/biopsy, it was not warranted. The Guardant 360 test was not the best available testing/procedure for this patient. This test is not likely to be more beneficial than any other standard treatments/procedures.

The carrier's denial of Genetic Testing 81201, 81272, 81173, 81321, 81210, 81275, 81310, 81120, 81235, 81276, 81311, 81121, 81270, 81293, 81314, 81400, 81401, 81402, 81403, 81404, 81405, 81406 and 81407 (Guardant 360 blood test) should be upheld.