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Next-Generation Sequencing – LymphoTrack Dx Assays

NGS is a powerful, high-throughput DNA sequencing technology that allows for massively parallel sequencing of millions of DNA fragments in a single sequencing run. NGS is revolutionizing modern science and healthcare.

Key benefits

• One-step PCR for amplicon and library generation
• Identify and assess mutation status of B- and T-cell gene rearrangements
• Sequence amplicons from any LymphoTrack kit together
• Included bioinformatics software for easy analysis and interpretation
• Same reagents for clonality, somatic hypermutation (SHM), minimal residual disease (MRD) testing, and tracking/monitoring of immunotherapy constructs

Minimal Residual Disease (MRD) Solution – Research Use Only (RUO)

MRD testing with Next-Generation Sequencing is a proven tool that may be used to develop hematologic malignancy management strategies.

• Complete solution for MRD clonality
• Ensures test sensitivity to enable confidence in reporting
• Facilitates standardization of clonotype tracking
• LymphoTrack MRD Software for automated analyses with PDF Reports
• Longitudinal assessment of mutation status of IGH and T-cell clonality including gene rearrangements and somatic hypermutation (SHM)
• LymphoTrack Assays formatted for both Illumina® and Thermo Fisher® NGS Platforms available

ABI Fluorescence Detection and Gel Detection – IdentiClone Assays

Invivoscribe exclusively offers a comprehensive selection of PCR-based assays for ABI fluorescence detection and gel detection, including targeted FLT3 ITD and TKD mutation assays, B- and T-cell clonality assays (based on EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936), and translocation assays.

Key benefits

• Eliminates discordance between laboratories
• Streamlines workflow
• Simplifies cross-training and assay validation
• Well-characterized positive and negative controls are provided

Controls and reagents

Invivoscribe offers an extensive range of General Purpose Reagents (GPRs) and Research Use Only (RUO) nucleic acid controls.

Companion Diagnostics (CDx)

Invivoscribe is a Comprehensive Partner for Companion Diagnostic Development.

LeukoStrat CDx FLT3 Mutation Assay in the only internationally standardized CE-IVD assay for FLT3 Signal Ratio mutation analysis for assessment of acute myeloid leukemia (AML) patients eligible for treatment with RYDAPT® (midostaurin) or XOSPATA® (gilteritinib fumarate).

Intended Use: The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).

In regions where midostaurin is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.

In regions where gilteritinib fumarate is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib fumarate) treatment is being considered.

Disclaimers

• MRD Applications and RUO products are Research Use Only; not for use in diagnostic procedures.
• LymphoTrack Dx Assays, IdentiClone Assays and LeukoStrat CDx FLT3 Mutation Assay are in vitro diagnostic products and are available outside in regions that accept CE-IVD products.