PRODUCTS

ABI Fluorescence Detection (CE-IVD)

PRODUCTS

ABI Fluorescence
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 ABI fluorescence detection, including 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 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 standardized health care solutions.

We exclusively offer a comprehensive selection of PCR-based assays for ABI fluorescence detection, including 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 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/rearrangements, 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 rearrangements, 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.
ABI FLUORESCENCE DETECTION

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ABI FLUORESCENCE DETECTION

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