Mibiton grant

Skyline Diagnostics, Erasmus MC and Sanquin Receive a Mibiton Share Facility Grant for International Study to Develop Acute Myeloid Leukemia Diagnostic Device

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Rotterdam, The Netherlands, 15-11-2010 - Skyline Diagnostics, a developer of microarray-based diagnostic tests for personalized medicine, announces today that it has received a 0.5 million euro Mibiton grant in collaboration with Sanquin and the department of Hematology of the Erasmus MC. This will allow these partners to acquire 5 Affymetrix DX2 microarray analyzer systems to support a large multi-site trial aiming for registration of the AMLprofiler diagnostic device for patients with Acute Myeloid Leukemia. The VALID trial, involving 6 renowned sites in Europe and the USA, is expected to result in a full Pre-Market Approval by the American Food and Drug Administration towards the end of 2011. This level of regulatory approval is unique and unprecedented for a microarray-based diagnostic test. The AMLprofiler is currently available as a CE-cleared laboratory testing service in Europe. In the first quarter of 2011 the AMLprofiler will be available worldwide, with exception of the USA, as a CE-cleared In Vitro Diagnostic device.

“We are very pleased with this crucial financial support by Mibiton, enabling us to pioneer the path towards regulatory approval for this new generation of diagnostic tests,” says Henk Viëtor, Skyline Diagnostics’ Chief Executive Officer, “Regulatory approval of the AMLprofiler at the highest level will make this unique test available to the benefits of leukemia patients worldwide.” 

“Our Share investment program enables collaborating SMEs and related stakeholders to further develop their product pipeline” said Kees Recourt, Investment Manager of Mibiton, “Our board feels confident that the Skyline Diagnostics consortium will be successful in further validating their lead product the AMLprofiler.”

Acute Myeloid Leukemia is a cancer of the bone marrow in which the rapid proliferation of abnormal cells interferes with normal blood cell production, with 200,000 new cases worldwide annually. It is the deadliest form of leukemia causing more than 9,000 deaths per year in the US. The AMLprofiler in vitro diagnostic test simplifies the recognition of AML subtypes by replacing 9 separate assays, combining cytogenetics, mutation analysis and expression analysis, in a single microarray-based test. With the AMLprofiler, more than 50% of the intermediate risk group of AML patients can be reclassified into either the favorable or the unfavorable risk group, thus facilitating the clinical decision making process. The NPM1 mutation status is associated with good disease prognosis and may influence treatment options.

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.

Skyline Diagnostics B.V. Contact ∙ Henk Viëtor ∙ +31 (0)10 7038410

Skyline Diagnostics B.V. E-mail contact ∙ info@skyline-diagnostics.com

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

About Mibiton

The Mibiton Foundation with its main office in The Hague, The Netherlands, enables Dutch Life Sciences SMEs to exploit state-of-the-art facilities and equipment. With its three funding programs Share, Solo and Science the Mibiton foundation targets both collaborating SMEs and individual (start-up) Life Sciences companies which are not able to finance their facilities using commercial funding. The Mibiton Share program is co-funded by the Ministry of Economic Affairs, Agriculture and Innovation. The Mibiton Science program is co-funded by the Netherlands Genomics Initiative.

Mibiton Contact ∙ Mrs. Vera Blom ∙ +31 (0)70 337 8780

Mibiton E-mail contact ∙ blom@mibiton.nl

Mibiton Website ∙ http://www.mibiton.nl