TEST:

GuardantOMNI

GuardantOMNI is a highly sensitive 500-gene cfDNA sequencing test developed by Guardant Health for biopharmaceutical research use. It is designed to accelerate clinical development programs in immuno-oncology and targeted therapy by profiling patients across an unparalleled number of clinical trial targets from a simple blood draw. The panel detects SNVs and small indels in 497 genes, copy number amplifications in 106 genes, and fusions in 21 genes. It also enables assessment of TMB and DNA damage/mismatch repair with coverage of over 30 DDR pathway genes. Launched in 2017 in partnership with leading pharmaceutical companies, it requires as little as 2 mL of plasma. It is a research-use product, distinct from the FDA-approved Guardant360 CDx clinical test.