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CE Marked Diagnostic Assays (Not for sale in the US)
The LymphoTrack® Dx IGH FR1 Assays are in vitro diagnostic products intended for next-generation sequencing (NGS) based determination of the frequency distribution of IGH gene rearrangements as well as the degree of somatic hypermutation of rearranged genes in patients suspected of having lymphoproliferative disease. These assays aid in the identification of lymphoproliferative disorders as well as providing an aid in determining disease prognosis.
The LymphoTrack® Dx TRG Assays are in vitro diagnostic products intended for next-generation sequencing (NGS) based determination of the frequency distribution of TRG gene rearrangements in patients suspected with having lymphoproliferative disease. These assays aid in the identification of lymphoproliferative disorders.
The IdentiClone™ IGH Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal immunoglobulin heavy chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ IGK Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal immunoglobulin kappa light chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ IGL Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal immunoglobulin lambda light chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ TCRB Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal T-cell receptor beta chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ TCRD Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal T-cell receptor delta chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ TCRG Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal T-cell receptor gamma chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ BCL1/JH Translocation Assay is an in vitro diagnostic product intended for PCR-based detection of BCL1/JH t(11;14)(q13;q32) gene translocations in patients with suspect lymphoproliferations.
The IdentiClone™ BCL2/JH Translocation Assay is an in vitro diagnostic product intended for PCR-based detection of BCL2/JH t(14;18) gene translocations in patients with suspect lymphoproliferations.
This LeukoStrat™ PCR assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and E836 mutations.