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Invivoscribe PCR/CE tests for lymphoproliferative diseases

Standardized tools for detection and monitoring of lymphoproliferative diseases

Invivoscribe exclusively offers a comprehensive selection of PCR-based assays for ABI fluorescence detection, including targeted FLT3 mutation assays, B- and T-cell clonality assays (based on EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936), and translocation assays. LeukoStrat CDx FLT3 is the first IVDR certified kit for AML diagnosis.


Leukemias and lymphomas originate from the malignant transformation of individual lymphoid cells, all leukemias and lymphomas generally share one or more cell-specific or “clonal” antigen receptor gene rearrangements. Therefore, tests that detect clonal rearrangements can be useful in the study of B- and T-cell malignancies.

IdentiClone products PCR-based assays for ABI fluorescence detection of B- and T-cell clonality. These kits are designed to test DNA extracted from a variety of samples to identify targeted mutations, translocations, and clonal populations in suspect lymphoproliferations. Products offered are CE-IVD marked and based on EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.

Offered clonality assays:

  • T-lymphocytes: TCRB, TCRG, TCRD
  • B-lymphocytes: IGH, IGK, IGL, IGHV

Offered translocations assays: e.g. BCL1/JH, BCL2/JH, PML/RARa

LeukoStart FLT3 assays are intended for PCR-based capillary detection of FLT3 activating mutations in patients with acute myelogenous leukemia (AML). These molecular diagnostic products are used to test DNA extracted from a variety of patient samples and have demonstrated clinical efficacy identifying internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene. Many studies in AML have shown that the presence of FLT3 activating mutations portends a poor prognosis making it an attractive target for treatment.

The LeukoStrat FLT3 Mutation Assay 2.0 is an in vitro diagnostic product intended for PCR-based detection of FLT3 activating mutations in patients with acute myelogenous leukemia (AML).

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based IVDR test designed to detect mutations in the FLT3 gene. The assay is intended as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) or XOSPATA® (gilteritinib fumarate) treatment is being considered.

The kit includes in addition to master mixes needed for analysis also Taq DNA polymerase and EcoRV enzyme.

Product is available in the following countries:

  • Finland
  • Estonia
  • Latvia
  • Lithuania

Links and documents

Manufacturer’s product page