Disclaimer:

This test was developed and its performance characteristics were determined by Ambry Genetics Corporation. The laboratory is regulated under the Clinical Laboratory Improvement Amendments 2003 as qualified to perform nonwaived testing. Although molecular tests are highly accurate, rare diagnostic errors may occur. The Ambry Test: Full Gene Analysis (FGA) analyzes the following types of mutations: nucleotide substitutions, small deletions, small insertions, and small indels. In addition, the Ambry Test: Gross Del/Dup analyzes the following types of mutations: gross insertions and gross deletions. Both methods technically could miss gross rearrangement mutations and other unknown abnormalities. The pattern of mutation types varies with the gene tested and the Ambry Test detects a high but variable percentage of known and unknown mutants of the classes stated. A negative result from the analysis cannot rule out the possibility that the tested individual carries a rare unexamined mutation or mutation in the undetectable group. A report does not represent medical advice. Any questions, suggestions, or concerns regarding interpretation of results should be forwarded to a genetic counselor, medical geneticist, or physician skilled in interpretation of the relevant medical literature. References are available upon request.