Circulating tumour DNA (ctDNA) tests

Testing can be used to detect ESR1, PIK3CA, AKT1 and PTEN variants.

ESR1 can be used to guide treatment decisions for treating oestrogen receptor-positive, HER2-negative advanced breast cancer with an ESR1 mutation after endocrine treatment. Patients must have completed at least 12 months of endocrine treatment plus a CDK 4 and 6 inhibitor.

PIK3CA/AKT1/PTEN can be used to guide treatment decisions for treating adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after endocrine treatment.

Testing can be used to detect a range of genetic variants including small variants in EGFR, ALK, BRAF, KRAS, MET (exon 14 skipping) and structural variants in ROS1, RET, ALK, NTRK1, NTRK2, NTRK3, MET (exon 14 skipping).

Eligible patients should have radiologically suspected stage III/IV lung cancer, likely unsuitable for curative intent surgery or radical radiotherapy and an ECOG Performance Status between 0-3. Or they should have a confirmed new histological diagnosis of NSCLC, previously untreated for advanced disease where diagnostic molecular testing has failed, and an alternative option would be to re-biopsy.