LeukoStrat CDx FLT3 Mutation Assay receives IVDR approval
Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay has been approved by BSI and the EMA as a Class C CDx assay.
Myeloid malignancies are clonal diseases of hematopoietic stem or progenitor cells. Myeloid malignant diseases comprise and acute (acute myeloid leukemia) stages.
Invivoscribe is dedicated to advancing diagnostic solutions for the characterization and treatment of myeloid malignancies. These malignancies include both chronic conditions like myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), chronic myelomonocytic leukemia (CMML), and acute stages such as acute myeloid leukemia (AML).
Acute myeloid leukemia (AML) and related neoplasms are aggressive disorders characterized by the rapid proliferation of abnormal myeloid cells. Early and accurate diagnosis is crucial for improving patient outcomes. Our diagnostic products and services are designed to help physicians make more informed treatment decisions through precise, reliable testing.
Mutations in the FLT3 gene are commonly found in AML patients and are associated with a higher risk of relapse and poor prognosis. Invivoscribe offers a range of globally standardized FLT3 testing solutions that provide essential data, enabling clinicians to tailor treatment plans and monitor therapy response effectively.
Now available in regions where CE 2797 IVD approved products are sold. The LeukoStrat® CDx FLT3 Mutation Assay is a globally standardized, PCR-based in vitro diagnostic test used to detect FLT3 mutations in AML patients. This test plays a critical role in making treatment decisions by identifying prognostic mutations that are also clinically actionable.
We are also excited to offer the FLT3 ITD MRD Assay & Software and the NPM1 MRD Assay & Software, providing clinicians with the tools needed for enhanced disease monitoring:
Featuring innovative approaches for measurable residual disease (MRD) detection using next-generation sequencing (NGS)
To learn more about our AML solutions and their clinical applications, watch the following video:
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