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Genetic Diseases - Cardiovascular Diseases
CLONIT - In Vitro Diagnostic Test Kit
DuplicαRealTime Next Factor V H1299R Kit is an in vitro diagnostic test for the detection of the nucleotide substitution A4070G of the blood coagulation Factor V gene, by Real-Time PCR.
Oncohematology
Vitro Diagnostic Test - PML-RARA t(15;17)(q22;q21)
The PML-RARA t(15;17)(q22;q21) is an in vitro diagnostic test for the detection and identification of the PML-RARA gene fusions resulting from the t(15;17)(q22;q21) , by multiplex one-step Real-Time PCR. The PML-RARA t(15;17)(q22;q21) allows also the detection and quantification of ABL as a endogenous control gene. Standard curves of known amounts of both the endogenous control and the gene fusion cDNA allow the calculation of the ratio of specific fusion transcript signal to endogenous control gene signal in each sample, allowing the identification of the minimal residual disease (MRD).
In Vitro Diagnostic Test - AML1-ETO t(8;21)(q22;q22)
The AML1-ETO t(8;21)(q22;q22) is an in vitro diagnostic test for the identification and quantification of the AML1-ETO gene fusion transcripts resulting from t(8;21)(q22;q22) , by one-step Real-Time PCR. The AML1-ETO t(8;21)(q22;q22) assay allows also the detection and quantification of ABL as a endogenous control gene. Standard curves of known amounts of both the endogenous control and the gene fusion cDNA allow the calculation of the ratio of specific fusion transcript signal to endogenous control gene signal in each sample, allowing the identification of the minimal residual disease (MRD). The device is intended for detecting the presence of gene fusion resulting from the t(8;21)(q22;q22), the most frequently observed chromosomal aberration associated with Acute Myeloid Leukemia (AML), and for determining disease status.