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Qiagen Hopes to Bolster Molecular Dx Play by Acquiring Assay Shop Genaco

Qiagen’s acquisition of Genaco Biomedical this week for $22 million in cash will add to the company’s molecular diagnostic offering, whose cornerstone comprises last year’s acquisitions of Artus and Shenzhen PG Biotech.
Privately held Genaco provides Qiagen with a PCR-based multiplexing technology and a handful of assays that the firm plans to pair with the quantitative molecular diagnostic products it gained through its earlier acquisitions.
The firm currently markets 11 assay panels for research use and is finishing clinical studies of an H5N1 avian flu assay that it plans to file for 510(k) clearance with the US Food and Drug Administration.
Genaco, based in Huntsville, Ala., has developed a proprietary PCR-based multiplexing technology, called Tem-PCR, which it uses with Luminex’s xMap technology to develop molecular diagnostics.
According to Genaco, Tem-PCR “overcomes the obstacles” of traditional multiplex PCR assay development by specifically and sensitively amplifying multiple targets in a single reaction tube.
The PCR products are labeled during amplification and use the xMap platformto do the detection.

According to a Qiagen spokesperson, Genaco has used this setup to develop and sell 11 test panels. The firm’s tests include panels for respiratory infections, including nosocomial infections, and food-borne illnesses. They are currently sold for research use only.

Qiagen also noted that Genaco is finishing clinical studies on its H5N1 avian flu assay, which is part of its ResPlex III panel, and plans to file for US Food and Drug Administration 510(k) clearance.
The Qiagen spokesperson said the firm expects that the Templex panels will serve to qualitatively detect potential targets that will later be quantitatively tested by tools from Artus or other companies.
Genaco Advantage?
Genaco’s Tem-PCR technology employs a combination of nested primers and SuperPrimers that Qiagen believes give the assays an edge over competing technologies. According to the spokesperson, the Tem-PCR technology increases sensitivity and uniform efficiency by using only one pair of highly concentrated generic SuperPrimers with an elevated affinity to Taq polymerase.
In addition, Qiagen said that although the assays can be used on a variety of detection instruments, they are currently optimized and marketed for use on Luminex’s bead-based platform. Qiagen has been selling its LiquiChip system, which is a modified version of Luminex’s platform, since 2000.
Qiagen’s spokesperson said that multiplexing has “huge potential” in the future molecular diagnostics market. “The opportunity to test for several targets with just one test will become increasingly important,” the spokesperson wrote an e-mail to Pharmacogenomics Reporter sister publication BioCommerce Week.
According to Qiagen, multiplex molecular diagnostic tests for genetic and human leukocyte antigen testing have been widely adopted. For instance, PerkinElmer, the world’s leading genetic test maker, signed a deal earlier this year to standardize its multiplex assay development on Luminex’s xMAP platform.
Genaco has 15 employees, who are all expected to join Qiagen. The acquisition is expected to add $200,000 in revenue to Qiagen’s sales in the fourth quarter, and $3 million in sales for all of 2007.
Qiagen acquired the company for $22 million in cash, plus 125,000 shares of restricted Qiagen stock that was issued to Genaco’s founder and chief scientist. Qiagen said that it also agreed to pay up to $18 million in milestones, which will be triggered when the firm receives certain anticipated grants and comparable funding.
    Kirell Lakhman contributed to this report.

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