Innovatiekrediet

Skyline Diagnostics Receives Dutch Innovation Support for Regulatory Approval of Novel Leukemia Diagnostic in the USA

Rotterdam, The Netherlands, March 9, 2011 - Skyline Diagnostics, a developer of innovative diagnostic tests for personalized medicine, has received a 1.1 million Euro innovation credit support for an international clinical study with the AMLprofiler™, a novel microarray-based diagnostic test for acute myeloid leukemia (AML). This support, an ‘Innovatiekrediet’ from NL Agency of the Dutch Ministry of Economic Affairs, Agriculture and Innovation, is a government-backed advance intended to stimulate development of technologically innovative products. The clinical study named ‘VALID’ involves six renowned academic hospitals in Europe and the USA and has been designed to result in Pre-market Approval (PMA) from the American Food and Drug Administration (FDA). This approval is an important prerequisite for market introduction of the AMLprofiler in the USA, which is planned in 2012.

“The ‘Innovatiekrediet’ provides substantial financial support for our VALID study, which in turn is instrumental for regulatory approval of the AMLprofiler by the FDA in the United States” says Henk Viëtor, Skyline Diagnostics’ Chief Executive Officer, “Only by meeting the FDA’s high standards for diagnostic testing, we are able to let leukemia patients worldwide profit from better healthcare based on the results of the AMLprofiler.”

Acute Myeloid Leukemia is a cancer of the bone marrow, with 200,000 new cases worldwide annually. It is the deadliest form of leukemia causing more than 9,000 deaths per year in the USA. The AMLprofiler in vitro diagnostic test simplifies the recognition of AML subtypes by replacing 7 to 9 separate assays, combining cytogenetics, mutation analysis and expression analysis, in a single microarray-based test. The AMLprofiler reclassifies a significant portion of the intermediate risk group of AML patients into either the favorable or the unfavorable risk group, thus facilitating and improving the clinical decision making process.

About Skyline Diagnostics BV

Skyline Diagnostics™ with its headquarters in Rotterdam, The Netherlands, develops and markets array-based diagnostic tests using gene signatures for personalized medicine. The company has successfully translated several important scientific discoveries into diagnostics. These products, called Profilers, are based on gene expression and offer a high additional clinical value. Skyline Diagnostics’ Profilers will provide the clinician in-depth insight in the prognosis of individual patients and facilitate the treatment decision-making process. The company has built strong collaborations with leading scientists and has strategic alliances with industrial partners for distribution and manufacturing, including a ‘Powered by Affymetrix’ partnership.

For more information:

Henk Viëtor

Chief Executive Officer

Tel +31 (0)10 7038410

Skyline Diagnostics B.V. E-mail contact h.vietor@skyline-diagnostics.com

Skyline Diagnostics Website: http://www.skyline-diagnostics.com

About NL Agency

NL Agency is a department of the Dutch Ministry of Economic Affairs, Agriculture and Innovation that implements government policy for sustainability, innovation, and international business and cooperation. It is the contact point for businesses, (knowledge) institutions and government bodies for information and advice, financing, networking and regulatory matters. The ‘Innovatiekrediet’ is a risk-bearing loan to support development projects that combine a high commercial potential with a high technological development risk. Projects should aim to generate new products, processes or services. The ‘Innovatiekrediet’ is intended to decrease the development risk for businesses by waiving the loan under certain conditions if the project does not succeed. Separate budgets are available for technical and clinical development projects.

For more information about NL Agency, please visit www.agentschapnl.nl

For more information about the Innovatiekrediet, please visit www.nlinnovatie.nl/innovatiekrediet