Limitations of testing

As with any medical test, infrequent errors may occur in specimen labelling or laboratory processing. The rate of errors related to specimen handling is estimated from validation studies to be less than 1%. Although the sensitivity of this assay to detect typical disease-related variants is very high, failure to detect certain types of genetic alterations may result from technical limitations in DNA sequencing and computer-assisted analysis. False positive results are very infrequent (<1%) because of independent confirmation of all reported genetic variants.