Internationally Standardized Testing

Cytogenetic identification of chromosome abnormalities has become essential for the clinical management of patients with leukemia and is currently used to help categorize patients into risk groups.

LabPMM’s MRD tests are NGS-based assays that can be used to detect clonal gene rearrangements identified at diagnosis within virtually all of the antigen receptor loci for both B- and T-cells.

FLT3 and NPM1 assays are offered to detect targeted mutations.

The unique process of genetic rearrangements in the immunoglobulin (Ig) and T-cell receptor (TCR) gene loci during immune cell development and maturation generates a vast pool of genetically distinct cells.

The fms related tyrosine kinase 3 (FLT3) is one of the most commonly mutated genes in acute myeloid leukemia (AML), occurring in approximately 30% of patients at the time of diagnosis¹. Although generally associated with normal cytogenetics where patients have standard risk of relapse, FLT3 mutations have also been identified in sub-groups of patients with chromosomal abnormalities that are associated with high risk of disease relapse^2-3.

In response to the FDA announcing its intention to dramatically expand its regulatory oversight of laboratory developed tests (LDTs), Invivoscribe is partnering with laboratories worldwide to help facilitate the conversion of LDTs into FDA-cleared assays, as we know the barriers to bringing new assays online are often the availability of resources and the cost of validation.