ABI Fluorescence Detection (CE-IVD)2019-07-18T22:53:39+00:00
PRODUCTS

ABI Fluorescence Detection (CE-IVD)

PRODUCTS

ABI Fluorescence
Detection
(CE-IVD)

Providing high quality, standardized molecular tools and globally harmonized health care solutions.

We exclusively offer a comprehensive selection of PCR-based assays for ABI fluorescence 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.
Products offered include CE-Marked IVD and Companion Diagnostic kits. These kits are designed to test DNA extracted from a variety of samples to identify targeted mutations, translocations, and clonal populations in suspect lymphoproliferations. Developed under ISO 13485 design control, our kits are used extensively across the world.

Providing high quality, standardized molecular tools and globally harmonized health care solutions.

We exclusively offer a comprehensive selection of PCR-based assays for ABI fluorescence 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.
Products offered include CE-Marked IVD and Companion Diagnostic kits. These kits are designed to test DNA extracted from a variety of samples to identify targeted mutations, translocations, and clonal populations in suspect lymphoproliferations. Developed under ISO 13485 design control, our kits are used extensively across the world.
PATIENT INFORMATION

Why it Matters

Detection, assessment and monitoring of point mutations, internal tandem duplications, and chromosomal aberrations can provide important insights to aid in patient care and treatment decisions.

PCR-based molecular testing is widely recognized as the gold standard to characterize and monitor chromosomal aberrations often associated with leukemias and lymphomas. Providing comprehensive solutions, Invivoscribe offers an array of assays for B- and T-cell gene clonality/rearrangements, point mutations, internal tandem duplications, and chromosome translocations for the assessment of hematologic malignancies.
TECHNICAL INFORMATION

How it Works

Our standardized tests can eliminate discordance between laboratories, streamline workflow, and simplify cross-training and assay validation.

Leukemias and lymphomas are sometimes challenging to identify by morphology, immunohistochemistry, and flow cytometry. Our PCR-based CE-marked IVD fluorescence detection assays are globally used to assess B and T-cell clonality point mutations, internal tandem duplications, and chromosomal aberrations in both research and clinical applications.
PATIENT INFORMATION

Why it Matters

Detection, assessment and monitoring of point mutations, internal tandem duplications, and chromosomal aberrations can provide important insights to aid in patient care and treatment decisions.

PCR-based molecular testing is widely recognized as the gold standard to characterize and monitor chromosomal aberrations often associated with leukemias and lymphomas. Providing comprehensive solutions, Invivoscribe offers an array of assays for B- and T-cell gene clonality/rearrangements, point mutations, internal tandem duplications, and chromosome translocations for the assessment of hematologic malignancies.
TECHNICAL INFORMATION

How it Works

Our standardized tests can eliminate discordance between laboratories, streamline workflow, and simplify cross-training and assay validation.

Leukemias and lymphomas are sometimes challenging to identify by morphology, immunohistochemistry, and flow cytometry. Our PCR-based CE-marked IVD fluorescence detection assays are globally used to assess B and T-cell clonality point mutations, internal tandem duplications, and chromosomal aberrations in both research and clinical applications.

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 other available indicative characteristics. 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 other available indicative characteristics. Our tests detect clonal rearrangements and are useful in the characterization and treatment of B- and T-cell malignancies.

CE-IVD

IdentiClone assay kits are in vitro diagnostic products.

Intended for PCR-based ABI fluorescence detection of clonal rearrangements in patients with suspected lymphoproliferations. These molecular diagnostic products are used to test DNA extracted from a variety of patient samples to identify clonal populations in suspect malignancies. Our IdentiClone CE-marked in vitro diagnostic products are for sale and use only in the EU and other regions where CE-marked products have been appropriately listed.

CE-IVD

IdentiClone assay kits are in vitro diagnostic products.

Intended for PCR-based ABI fluorescence detection of clonal rearrangements in patients with suspected lymphoproliferations. These molecular diagnostic products are used to test DNA extracted from a variety of patient samples to identify clonal populations in suspect malignancies. Our IdentiClone CE-marked in vitro diagnostic products are for sale and use only in the EU and other regions where CE-marked products have been appropriately listed.

FLT3

Presence of a FLT3 mutation in patients with AML is both highly prognostic and clinically actionable.

Since FLT3 mut+ AML is both highly prognostic and clinically actionable, stratification of acute myeloid leukemia (AML) patients by testing for FLT3 mutation status has become a standard of care. FLT3 is a receptor tyrosine kinase that is normally expressed on many cell types including hematologic stem cells. Of those diagnosed with AML, ~1 out of 3 are expected to have presence of FLT3 mutations, which portend a worse prognosis (FLT3 mut+).
In fact, some treatment regimens and targeted drug trials are only accessible to patients who test positive for the mutation; a false negative FLT3 test result can also have serious implications for the patient.
Offering the only internationally standardized FLT3 mutation test manufactured and validated to meet international regulatory standards, our kits detect both FLT3 ITD and FLT3 TKD mutations. In addition to our distributable kits, we further offer FLT3 reagents in the United States (US).

FLT3 ITD

The most prevalent and clinically significant type of FLT3 mutation is an Internal Tandem Duplication (ITD) in the juxtamembrane domain of the receptor.

Knowing the FLT3 mutation status can help stratify patients into groups that will receive different post-remission treatments. The signal ratio has been demonstrated to provide prognostic value in both adult and pediatric AML patients. Patients with high FLT3 ITD signal ratios are likely to have less favorable outcomes.

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.

FLT3 TKD mutations are caused by nucleic acid substitutions and/or deletions that result in a change in the amino acid sequence in this highly conserved catalytic center. TKD mutations result in constitutive autophosphorylation and activation of FLT3.

FLT3

Presence of a FLT3 mutation in patients with AML is both highly prognostic and clinically actionable.

Since FLT3 mut+ AML is both highly prognostic and clinically actionable, stratification of acute myeloid leukemia (AML) patients by testing for FLT3 mutation status has become a standard of care. FLT3 is a receptor tyrosine kinase that is normally expressed on many cell types including hematologic stem cells. Of those diagnosed with AML, ~1 out of 3 are expected to have presence of FLT3 mutations, which portend a worse prognosis (FLT3 mut+).
In fact, some treatment regimens and targeted drug trials are only accessible to patients who test positive for the mutation; a false negative FLT3 test result can also have serious implications for the patient.
Offering the only internationally standardized FLT3 mutation test manufactured and validated to meet international regulatory standards, our kits detect both FLT3 ITD and FLT3 TKD mutations. In addition to our distributable kits, we further offer FLT3 reagents in the United States (US).

FLT3 ITD

The most prevalent and clinically significant type of FLT3 mutation is an Internal Tandem Duplication (ITD) in the juxtamembrane domain of the receptor.

Knowing the FLT3 mutation status can help stratify patients into groups that will receive different post-remission treatments. The signal ratio has been demonstrated to provide prognostic value in both adult and pediatric AML patients. Patients with high FLT3 ITD signal ratios are likely to have less favorable outcomes.

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.

FLT3 TKD mutations are caused by nucleic acid substitutions and/or deletions that result in a change in the amino acid sequence in this highly conserved catalytic center. TKD mutations result in constitutive autophosphorylation and activation of FLT3.

CE-IVD

The LeukoStrat FLT3 Mutation Assays are in vitro diagnostic kits intended for PCR-based gel or capillary detection of FLT3 activating mutations in patients with acute myelogenous leukemia (AML). They 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. Our CE-marked in vitro diagnostic products are for sale and use in the EU and other regions where CE-marked products have been appropriately listed.

CE-IVD

The LeukoStrat FLT3 Mutation Assays are in vitro diagnostic kits intended for PCR-based gel or capillary detection of FLT3 activating mutations in patients with acute myelogenous leukemia (AML). They 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. Our CE-marked in vitro diagnostic products are for sale and use in the EU and other regions where CE-marked products have been appropriately listed.