Acquired genetic alteration IVDs

Intended purpose

IVDs that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information. These products are intended for use as an adjunct to classic cytogenetics and not as independent tests or assays.