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Skyline Diagnostics

Skyline has received $1.5 million from the Dutch government to support a clinical study of AMLprofiler that will generate data it can use when it seeks US Food and Drug Administration clearance for the test next year.

Skyline Diagnostics' AMLprofiler leukemia test recently became the fourth Affy-based test to hit the market. Some of the company's other diagnostic partners, however, have changed their development strategies since the "Powered by Affymetrix" program was launched.

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

Skyline Diagnostics will use the NPM1 biomarker technology in a microarray testing service to stratify AML patients.

The molecular diagnostics company, based in Rotterdam, the Netherlands, will use the proceeds to fund additional validation studies of its Affymetrix-manufactured test for acute myeloid leukemia, as well as to flesh out its business-development team as it ramps up for an eventual US launch.


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