NPM1 license

Skyline Diagnostics closes licensing agreement with TrovaGene to use NPM1 mutation detection in novel technology for Acute Myeloid Leukemia diagnosis

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Rotterdam, The Netherlands, 30-6-2010 - Skyline Diagnostics, a developer of array-based diagnostic tests using gene signatures for personalized medicine, announces today that it has licensed NPM1 technology from TrovaGene, Inc (TROV.PK), San Diego, CA, USA to include in its AMLprofiler™ diagnostic service for Acute Myeloid Leukemia. AMLprofiler will be initially offered as a laboratory testing service in Europe and will be expanded to markets outside of Europe in the near future.

“The addition of NPM1 mutation testing to the AMLprofiler microarray renders it the most comprehensive in vitro diagnostic test on the market for Acute Myeloid Leukemia,” said Henk Viëtor, MD, Skyline Diagnostics’ Chief Executive Officer, “This agreement with TrovaGene enables us to provide clinicians worldwide with the best diagnostic tool for individualized patient care for AML.”

“We are pleased that Skyline Diagnostics will be providing our NPM1 technology in an innovative microarray product as a laboratory testing service,” said Andreas Braun, TrovaGene’s Chief Medical Officer, “This new testing service for AML patients should lead to improve patient outcomes by helping to monitor effective treatment decisions.”

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 ∙ E-mail contact ∙ info@skyline-diagnostics.com ∙ Website ∙ http://www.skyline-diagnostics.com

About TrovaGene, Inc.

With its headquarters and product development in San Diego, California, TrovaGene has focused on development of tests using its patented transrenal nucleic acid technology. Transrenal DNA (Tr-DNA) and RNA (Tr-RNA) are short nucleic acid fragments from normal cell death that cross the kidney barrier and can be detected in urine. Safe and simple urine collection and analysis can replace biopsy or blood sampling and has a broad range of applications, including tumor detection and monitoring, infectious disease detection, prenatal testing, tissue transplantation, genetic testing for forensic identity determination, and testing associated with drug development. The TrovaGene molecular diagnostics assays will provide information that will enable physicians to provide personalized medical care for their patients.

TrovaGene has a dominant patent position as it relates to transrenal molecular testing. It has issued U.S. and European patents that cover any and all testing for molecular targets that pass through the kidney. In addition to these core patents it has numerous patent applications pending in the areas of cancer, infectious diseases, transplantation, prenatal and genetic testing. This patent position rivals the importance of the Roche PCR and Gen-Probe ribosomal RNA patents in the molecular diagnostic field.

Statements about TrovaGene's expectations, applications of its technology, markets, and other statements that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management's current beliefs, assumptions, estimates and projections. Actual results may differ materially from those projected in the forward-looking statements for various reasons, including risks associated with product development, government regulation, market acceptance, and dependence on key personnel, obtaining financing and other factors.

TrovaGene, Inc. Contact ∙ Dr. Andreas Braun ∙ +1 858∙217∙4838 x104 ∙ Website ∙ http://www.trovagene.com