Multiple Myeloma Enriched Microarray and Multiple Myeloma FISH

This test is a diagnostic test for multiple myeloma. Plasma cell enrichment diagnosis increased as much as 50% to 100%. The FISH results on the enriched assay should not be used as a quantitative assay, since the abnormal cells do not represent the percentage of abnormal cells in the aspirate. The SNP assay will detect chromosomal imbalance that may be present in neoplastic disorders and clonal evolution. It provides detection of copy-neutral loss of heterozygosity of any chromosome, and the percent and location of homozygosity, that may be associated with cancer gene mutations.

Indicate pertinent clinical diagnosis and previous cytogenetics studies on the test request form.

The SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin or tetraploidy.

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

Fluorescence in situ hybridization (FISH) and plasma cell enrichment. SNP microarray analysis is performed using the Cytoscan® HD platform, which uses more than 743,000 SNP probes and 1,953,000 NPCN probes with a median spacing of 0.88 kb.