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Protagen meets with FDA

02-23-2009 06:23 PM CET | Health & Medicine

Press release from: Protagen AG

/ PR Agency: Biotech Consulting
Dortmund, Germany and New Jersey, USA, February 19, 2009. Protagen AG, a leading provider of GMP compliant protein analytical services, protein bioinformatics, and protein biochips announces that it participated in two meetings with FDA personnel during the week of January 26, 2009. The meetings were intended to provide a detailed introduction to the company’s UNIarray® technology position and its potential use in the development of novel diagnostics for multiple sclerosis and prostate cancer based on the determination of autoantibody signatures in patient blood samples.

Numerous pharmaceutical and biotechnology companies are now using Protagen’s technology for the development of companion diagnostics for their drug/biological development programs and other companies are expected to use it in the near future. These products may soon come before the Agency for regulatory approval.

Background: UNIarray® is a unique and promising technology platform for the development of novel diagnostics based on indication specific autoantibody patterns in patient sera. These indication specific autoantibody patterns were already proven to be present in several autoimmune diseases, but also in cancer, neurodegenerative disorders, and even in apparently healthy individuals. Therefore, the systematic and indication-specific determination of autoantibody patterns will serve as a unique basis to address hitherto unmet diagnostic needs. In addition, UNIarray® serves as a platform for the development of product specific companion diagnostics and patient stratification for clinical studies. In-house research at Protagen is presently focused on novel diagnostics for prostate cancer, multiple sclerosis, rheumatoid arthritis, juvenile idiopathic arthritis, Morbus Parkinson, and Alzheimer’s.

About Protagen AG
Protagen AG (www.protagen.de), a leading provider of GMP compliant protein analytical services, protein bioinformatics, and protein biochips with sites in Dortmund, Germany, and Chester, New Jersey, USA. Technology innovations of Protagen are UNIclone®, a patented platform for development and use of protein expression libraries, and UNIchip®, a versatile and highly efficient family of products for the development of antibodies, as well as UNIarray®, unique technology base for the development of new diagnostics.

Contact
Dr. Stefan Müllner
CEO
Protagen AG
Otto-Hahn-Str. 15
44227 Dortmund
Tel: +49 (0) 231 9742 6300
Fax: +49 (0) 231 9742 6301
E-Mail: info@protagen.de

Media Enquiries
Dr. Holger Bengs
Biotech Consulting
Tel: +49 (0) 69 6199 4273
Fax: +49 (0) 69 6199 4249
E-Mail: info@holgerbengs.de

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