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TrovaGene Licenses AML Biomarker to Skyline Diagnostics


By Justin Petrone

Skyline Diagnostics has licensed rights to TrovaGene's NPM1 biomarker for use in a test that will help guide acute myelogenous leukemia treatment, TrovaGene said this week.

Skyline will use TrovaGene's nucleophosmin protein mutation, which is found in around 35 percent of AML patients and is associated with good disease prognosis, in its Affymetrix-manufactured AMLprofiler in vitro diagnostic.

Under the terms of the agreement, Rotterdam, the Netherlands-based Skyline has the right to include NPM1 in its AMLprofiler via a laboratory testing service in Europe, and, as its testing service expands, worldwide.

Skyline CEO Henk Vietor said in a statement that the addition of the NPM1 marker to its panel will render it the "most comprehensive" IVD on the market for AML.

AMLProfiler allows users to classify AML patients into a number of subtypes by profiling gene expression. It also tests for the presence of particular chromosomal aberrations and gene mutations. The assay has been available for research use since January 2009.

Skyline received a CE Mark for AMLProfiler last December (BAN 12/2/2009). The company eventually intends to seek US Food and Drug Administration clearance to sell its test to clinicians in the US (BAN 1/5/2010).

Financial terms of the agreement were not released.

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