IdentiClone Gene Clonality Assays were developed and clinically validated by the BIOMED-2 Group. They are in vitro diagnostic products intended for PCR-based detection of clonal gene rearrangements in patients with suspect lymphoproliferations.

These standardized PCR-based tests include a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls.

Master Mixes
Master mixes are composed of a buffered solution containing magnesium, deoxynucleotides, and primers that target the gene segments of interest.

Multiple Primers
Multiple primers are used to ensure a more comprehensive testing approach necessary to reliably identify clonal rearrangements.

Assay Kits
These assay kits are complete, with the exception of Taq DNA polymerase. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training.

IGH Gene Clonality Assays
IGK Gene Clonality Assays
IGL Gene Clonality Assays

TCRB Gene Clonality Assays
TCRD Gene Clonality Assays
TCRG Gene Clonality Assays

IdentiClone Gene Translocation Assays were developed and clinically validated by the BIOMED-2 Group. They are in vitro diagnostic products intended for PCR-based detection of gene translocations in patients with suspect lymphoproliferations. These standardized PCR-based tests include a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls.

Master Mixes
Master mixes are composed of a buffered solution containing magnesium, deoxynucleotides, and primers that target the gene segments of interest.

Multiple Primers
Multiple primers are used to ensure a more comprehensive testing approach necessary to reliably identify gene translocations.

Assay Kits
These assay kits are complete, with the exception of Taq DNA polymerase. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training.

BCL1/JH t(11;14) Translocation Assays 
BCL2/JH t(14;18) Translocation Assays

LeukoStrat Gene Mutation Assays are in vitro diagnostic products intended for PCR-based detection of gene mutations in patients with acute myeloid leukemia (AML) and other lymphoproliferative diseases. These standardized PCR-based tests include a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls.

Master Mixes
Master mixes are composed of a buffered solution containing magnesium, deoxynucleotides, and primers that target the gene segments of interest.

Assay Kits
These assay kits are complete, with the exception of enzymes, which are identified by specific part number and vendor. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training.

FLT3 Mutation Assay