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The TRUPCR® C-KIT Mutation Detection Kit is a highly sensitive and specific PCR-based assay developed for the detection of the D816V point mutation in the C-KIT gene, commonly associated with acute myelogenous leukemia (AML) and other hematologic malignancies.
This real-time PCR kit is optimized to detect low-level mutations with a detection sensitivity of 1% mutant allele in a background of wild-type DNA. The assay is intended for use with genomic DNA extracted from peripheral blood, supporting risk stratification and informed clinical decision-making, especially in patients with core-binding factor leukemias.
Designed for clinical molecular labs, the TRUPCR® kit delivers fast, reliable results and is compatible with a wide range of real-time PCR platforms. Its streamlined, ready-to-use format reduces hands-on time and ensures reproducibility, making it a cost-effective tool in routine mutation screening and diagnostic workflows.
The TRUPCR® C-KIT Mutation Detection Kit is an in vitro diagnostic (IVD) assay designed for the qualitative detection of the D816V mutation in the C-KIT (KIT) gene using real-time PCR (qPCR) technology. This clinically relevant mutation is most frequently associated with acute myelogenous leukemia (AML) and particularly prevalent in cases of core-binding factor leukemias, such as those with t(8;21) or inv(16) chromosomal rearrangements.
This kit is intended for use with genomic DNA extracted from peripheral blood samples, and provides a highly sensitive method for detecting low-frequency mutant alleles—as low as 1% mutant DNA in a background of 99% wild-type DNA.
The KIT gene encodes a receptor tyrosine kinase involved in crucial cell signaling pathways that control cellular proliferation, differentiation, and survival. Mutations, particularly in exons 8 and 17, cause constitutive activation of the receptor, leading to uncontrolled hematopoietic growth and transformation. The D816V mutation, located in exon 17, results in the substitution of aspartic acid (D) with valine (V) at position 816 and is linked to a worse prognosis in AML patients, even those who would otherwise fall under favorable cytogenetic profiles.
Accurate detection of this mutation is critical for patient stratification, prognosis assessment, and in some settings, guiding therapeutic decisions—especially where targeted therapies are being considered.
The TRUPCR® C-KIT Mutation Detection Kit is optimized for clinical laboratory workflows, providing:
This assay is suitable for routine use in hematopathology, molecular diagnostics, and oncology-focused laboratories that manage AML patients.
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