BRCAssure®: Ashkenazi Jewish Panel

Technologies used do not detect germline mosaicism and do not rule out the presence of large chromosomal aberrations, including rearrangements, gene fusions, or variants in regions or genes not included in this test, or possible inter/intragenic interactions between variants. Variant classification and/or interpretation may change with time if more information becomes available. False-positive or false-negative results may occur for reasons that include: genetic variants, pseudogene interference, technical handling, blood transfusions, bone marrow transplantation, mislabeling of samples, or erroneous representation of family relationships. For heterozygous variants in the same gene, the assay cannot determine whether they are on the same or a different chromosome; to determine phase and clinical significance, rarely, parental testing may be required. Exact breakpoints of exon-level deletions/duplications are not determined. The presence of an inherited cancer syndrome due to a different genetic cause cannot be ruled out. Any interpretation should be clinically correlated with information about the patient's presentation and relevant family history.

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.