PRODUCTS
Gel Detection (CE-IVD)
PRODUCTS
Gel
Detection
(CE-IVD)
Providing high quality, standardized molecular tools and globally standardized health care solutions.
We exclusively offer a comprehensive selection of PCR-based assays for 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.
These kits are designed to test DNA extracted from a variety of samples to identify targeted mutations, translocations, and clonal populations in suspect lymphoproliferations. Offered as CE-marked IVD products developed under ISO 13485 design controls, our kits are used extensively across the world.
Providing high quality, standardized molecular tools and globally standardized health care solutions.
We exclusively offer a comprehensive selection of PCR-based assays for 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.
These kits are designed to test DNA extracted from a variety of samples to identify targeted mutations, translocations, and clonal populations in suspect lymphoproliferations. Offered as CE-marked IVD products developed under ISO 13485 design controls, our kits are used extensively across the world.
Clonality
Lymphoid cells are different from the other somatic cells in the body as during development, the antigen receptor genes in lymphoid cells undergo somatic gene rearrangement.
Since leukemia 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. Clonality does not always imply malignancy; all results must be interpreted in the context of all of the other available diagnostic criteria. Our tests detect clonal rearrangements and are useful in the characterization and treatment of B- and T-cell malignancies.
Clonality
Lymphoid cells are different from the other somatic cells in the body as during development, the antigen receptor genes in lymphoid cells undergo somatic gene rearrangement.
Since leukemia 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. Clonality does not always imply malignancy; all results must be interpreted in the context of all of the other available diagnostic criteria. Our tests detect clonal rearrangements and are useful in the characterization and treatment of B- and T-cell malignancies.
FLT3
FLT3 is a receptor tyrosine kinase that is normally expressed on many cell types including hematologic stem cells. Activating mutations in this gene are the most common mutations found in AML, occurring in approximately 30% of patients at the time of diagnosis, and promoting the growth of abnormal leukemia cells. Many studies in AML have shown that the presence of FLT3 activating mutations portends a poor prognosis making it an attractive target for treatment. For this reason, FLT3 mutation testing is recommended to stratify disease and determine treatment options.
FLT3 ITD
The most prevalent and clinically significant type of FLT3 mutation is an Internal Tandem Duplication (ITD) in the juxtamembrane domain of the FLT3 receptor. Stratification of AML patients by FLT3 ITD and TKD mutation status assists in treatment decisions.
FLT3 TKD
The second most common mutation type in the FLT3 gene is a Tyrosine Kinase Domain (TKD) point mutation in the codon for an aspartate (D835) or an isoleucine (I836) residue that are located in the activation loop of the FLT3 protein. TKD mutations result in constitutive autophosphorylation and activation of FLT3. Stratification of AML patients by FLT3 ITD and TKD mutation status assists in treatment decisions.
Translocations
Detection and assessment of translocations can provide important insights to aid in patient stratification and prognostication.
Certain translocations have been identified to result in the disruption or misregulation of normal gene function and contribute to oncogenesis. Our ABI fluorescence detection assays detect these translocations and provide important insights towards the identification of chromosomal aberrations suggestive of malignancies, determine leukemia and lymphoma lineages, and monitor and evaluate disease recurrence.
Translocations
Detection and assessment of translocations can provide important insights to aid in patient stratification and prognostication.
Certain translocations have been identified to result in the disruption or misregulation of normal gene function and contribute to oncogenesis. Our ABI fluorescence detection assays detect these translocations and provide important insights towards the identification of chromosomal aberrations suggestive of malignancies, determine leukemia and lymphoma lineages, and monitor and evaluate disease recurrence.
GEL DETECTION (CE-IVD)
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GEL DETECTION (CE-IVD)
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