Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
This clinical study will demonstrate the accuracy of the chromosomal aberration and gene
mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical
performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug
Administration for in vitro diagnostic use within the United States of America.
The objective is to demonstrate the positive and negative percent agreement of each marker
by comparing AMLProfiler results from multiple clinical participating sites with data
generated using a laboratory developed bi-directional sequencing method generated at the
molecular diagnostic reference lab.
The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or
APL specific chromosomal aberrations (specific recurrent translocations and inversions), as
well as expression of specific genetic markers in RNA extracted from bone marrow aspirates
of patients with Acute Myeloid Leukemia.
n/a
Observational Model: Case-Only
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