HemaVision® -7 | HV01-7

HemaVisionÒ-7 is a CE-marked in vitro diagnostic test for qualitative detection of the 7 most frequent
leukemia causing chromosomal translocations including more than 40 breakpoints plus associated
mRNA splice variants. Furthermore, HemaVisionÒ-7 detects new breakpoints and mRNA splice variants
for the 7 translocations. It is a fast one day test. The HemaVisionÒ-7 test has sensitivity (>99%) and
specificity (>96%).
Limit of detection is 10-8 mg of fusion RNA in a sample of 1 mg total RNA when the RNA quality is good.
This test provides a detailed description of the exon organization of fusion genes originating from
chromosome translocations. Use of the test is described by Salto-Tellez et al. (Ref 22).
HemaVisionÒ-7 is a qualitative test intended for use on total RNA samples from human blood or bone
marrow for presence of chromosomal translocations associated with leukemia. Tests should be
performed and results should be analysed by professionals only. The test is intended for use as an
adjunct to evaluation of Leukemia in conjunction with other clinicopathological factors (aid to
diagnosis).
The test is for professional use only.