Luminus Diagnostics classifies variants using a 5-tier system based on the American College of Medical Genetics (ACMG) guidelines. Likely Benign and Benign variants are not reported.
Mutations with known clinical significance and demonstrated to increase the risk of cancer
Genetic changes that have some preliminary clinical data suggesting an association with cancer but not sufficient to make a definitive determination of pathogenicity and associated cancer risk
Uncertain Pathogenicity (VUS)
Genetic changes with either conflicting data or no supporting data, thus a determination of pathogenicity cannot be made
Genetic changes with strong but limited evidence to be classified as benign and are not likely to increase the risk for cancer
Genetic changes that are previously reported and have sufficient evidence to be classified as benign with no clinical relevance