In the June 30 issue, IBO examined the acquisition of molecular diagnostic providers by companies traditionally associated with research instrumentation and products. QIAGEN NV is one such company. QIAGEN currently offers 34 CE-marked IVD assays, six CE-marked IVD sample preparation products, nine China State Food and Drug Administration– approved IVD assays and one FDA 510K-approved PAX RNA product. The company expects FDA 510K approval for its Genaco multiplex PCR assays in 2007 or 2008.

QIAGEN’s product lines consist largely of consumables for the collection, stabilization and sample preparation of lab samples. QIAGEN’s strategy has sought to make its products a standard in all market segments, from research, to applied testing, to diagnostics. QIAGEN also provides its products on an OEM basis to molecular diagnostic companies, including Roche, Veridex (Johnson & Johnson) and Beckman Coulter, and currently has over 15 OEM partners. As Dr. Thomas Theuringer, public relations manager for QIAGEN GmbH, told IBO, the company’s sample preparation platform and assays form an integrated solution to serve both research and diagnostics applications. “QIAGEN is one of only a few companies holding a worldwide PCR license for diagnostics, and the product portfolio includes standardized integrated solutions for sample and assay technologies, as well as automated solutions for streamlined laboratory workflows.” Asked what the company’s experience in research market contributes to its transition into molecular diagnostics, he replied, “QIAGEN’s brand and reputation facilitated the expansion into the molecular diagnostics market.”

QIAGEN’s expansion of its diagnostics business largely involves PCR-based assay technologies, a portfolio it has steadily built through acquisitions. In 2002, QIAGEN purchased GenoVision (see IBO 5/31/02), a provider of magnetic bead–based nucleic acid purification technology used in HLA-typing (Human Leukocyte Antigen) for transplantation diagnostics. In 2005, QIAGEN acquired artus GmbH (see IBO 5/31/05), giving it PCR-based molecular diagnostic assays for infectious disease and increasing its OEM business. GenoVision and artus both make CE-marked kits. QIAGEN then added the PCR assays of Shenzhen PG Biotech (see IBO 9/30/05). Adding multiplex PCR assays to its portfolio, QIAGEN’s acquired Genaco last year (see IBO 10/31/06). Genaco’s technology is based upon Luminex’s iMAP technology. Thus, QIAGEN’s acquisition of Digene (see IBO 6/15/07) will further position it as a major provider of iMAP-based assays.