Qiagen Acquires Genaco Biomedical Products

Qiagen N.V. (Venlo, The Netherlands) has acquired Genaco Biomedical Products, Inc.
(Huntsville, Alabama, USA), for U.S.$22 million in cash plus 125,000 shares of restricted Qiagen stock. In addition Qiagen will pay up to $18 million in milestone payments, generated by the receipt of anticipated grants and comparable funding in the same amount.

Qiagen provides molecular diagnostics products and supplies solutions for preanalytical sample preparation. Genaco is an early-stage company that applies polymerase chain reaction (PCR)-based multiplexing technology, Tem-PCR, to develop a line of molecular diagnostic tests under the Templex label.

Multiplexing is a rapidly emerging segment in molecular diagnostics in which multiple (i.e., more than 10) targets are screened for in one single test. Multiplex assays are typically applied in situations in which one or more of several pathogens or disease markers could be present in one sample. Depending on the number of markers present in a sample, the assays identify these pathogens or disease markers, providing a qualitative and a semi-quantitative answer. Multiplexing is used in cases where patients present symptoms that could be due to one or more different pathogens or causes.

Multiplexed molecular tests are widely adopted in genetic and human leukocyte antigen (HLA) testing. Newer applications include testing for viral and bacterial panels, testing for hospital acquired infections, and testing for bacterial drug-resistance mutations.

Genaco has developed multiplex testing products currently used by medical researchers to investigate respiratory hospital-acquired, and bacterial infections as well as additional panels for other pathogens. These products are currently available "for research use only” products. The ResPlexIII multiplex panel is designed to differentiate between different subtypes of influenza from a single sample. Genaco is in the process of completing clinical studies in order to submit a 510k application to the FDA for its H5N1 avian flu assay, which is a subset of its ResPlexIII panel product.

"Genaco has developed a truly innovative approach to sensitive and high-level multiplex testing,” said Peer M. Schatz, Qiagen's CEO. "We believe that multiplexed molecular diagnostic testing is increasingly attractive due to current trends in molecular diagnostics and research, where identifying pathogens and disease markers against a broad panel of potential markers in a quick and in a cost-efficient manner is developing into a significant need. The Genaco solutions leverage and employ Qiagen preanalytical and assay technologies and offer novel and highly attractive molecular diagnostics solutions to our customers in clinical research, applied testing, and molecular diagnostics.”

Genaco's proprietary Tem-PCR technology employs a combination of nested- and super-primers and thereby solves many of the issues associated with the current limitations of end-point and real-time PCR-based multiplexing. The technology is suitable for use on a wide array of detection instruments. It is currently optimized and marketed for use on the Luminex detection system, which Qiagen has also been selling since 2000. This acquisition will allow Qiagen to provide an automated, complete molecular diagnostics multiplexing solution for its applied testing, diagnostic, and research customers.



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