HemaVision®-inv16 | HV03-inv16

HemaVision-inv16 is a CE-marked in vitro diagnostic test for qualitative detection of the human
leukemia causing chromosomal translocation inv(16)(p13;q22)(CBFB-MYH11). The test screens RNA
from blood or bone marrow for breakpoints resulting in the exon fusions CBFB and MYH11 genes.
HemaVision-inv16 also detects mRNA splice variants for the inv(16)(p13;q22)(CBFB-MYH11)
translocation. It is a fast 4-5 hour test. The HemaVision-inv16 test has sensitivity (>99%) and
specificity (>96%).
Limit of detection is 10-8 g of fusion RNA in a sample of 1 g total RNA when the RNA quality is good.
This test brings IVD testing deeper into a detailed description of the exon organization of fusion genes
originating from chromosome translocations. This information is important for predicting development
of the disease and selection of treatment.
The test is for professional use only.