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Qiagen Expands Companion Dx Portfolio with Three Licensing Deals; Exceeds 2012 QiaSymphony Placement Target

This article has been updated from a previous version to clarify the fact that Qiagen placed 750 QiaSymphony instruments as of the end of 2012, not that it placed 750 instruments during the year. It expects a total of 1,000 placements by the end of 2013, not a total of 1,000 instruments during the year.

NEW YORK (GenomeWeb News) — Qiagen today said that it has signed three agreements to expand its companion diagnostic development pipeline.

The agreements — with Drug Response Dx, Insight Genetics, and InsermTransfert — will support the development of personalized diagnostics that will run on the company's QIAsymphony RGQ laboratory workflow system as well as a next-generation sequencing system that is currently in development based on technology it picked up in its acquisition of Intelligent Bio-Systems last June.

Separately, the company said that it had surpassed its 2012 goal for placements of the QiaSymphony system, with 750 installations as of the end of 2012.

Qiagen said that around 70 percent of the QiaSymphony systems it placed in 2012 were with molecular diagnostics customers through reagent rental agreements. The company expects to have more than 1,000 instruments placed by the end of 2013.

One of the biomarker agreements that the company disclosed today covers rheumatoid arthritis while the other two are in the field of oncology.

In the first agreement, the company made a strategic equity investment of an undisclosed amount in Hennigsdorf, Germany-based Drug Response Dx, which has developed proprietary rheumatoid arthritis biomarkers based on technology licensed from Max-Planck-Innovation.

The agreement gives Qiagen the option to obtain worldwide rights to the biomarkers for evaluating RA patients to guide treatment with TNF-alpha inhibitors.

Qiagen noted that therapy with TNF-alpha inhibitors is successful in 60 percent to 70 percent of rheumatoid arthritis patients, but treatment failure is not evident for about six months. As a result, the company said, a companion diagnostic to predict which patients are likely to respond to TNF-alpha inhibitors would improve the quality of life for patients who are not likely to respond, while also decreasing costs due to failed treatments.

The company said that the RA companion diagnostic would be "highly complementary" to its QuantiFeron-TB Gold test for latent tuberculosis, "since the prescribing information for many TNF-alpha inhibitors and other biological medicines requires testing for latent TB before use of the medicines."

Qiagen has also agreed to license exclusive worldwide rights from Nashville, Tenn.-based Insight Genetics for the RET, ROS1, and DEPDC1 biomarkers for use in non-small cell lung cancer.

According to Qiagen, these mutations are present in around 10 percent of all NSCLC cases, and therapies targeting RET and ROS1 have shown promise in clinical trials.

The agreement builds upon an existing partnership between Qiagen and Insight related to the development of a companion diagnostic based on the ALK gene, which several pharmaceutical companies are targeting for therapies for NSCLC and other malignancies.

In the third licensing agreement Qiagen disclosed today, the company's French subsidiary, Qiagen Marseille (formerly known as Ipsogen), has gained exclusive worldwide rights to a biomarker for mutations of the HSP110 gene, which enables identification of certain types of colorectal cancer.

Qiagen Marseille licensed the biomarker from InsermTransfert, the technology transfer arm of the French National Institute of Health and Medical Research.

Qiagen said it plans to develop the biomarker into a test for routine use in the diagnostic workup of colorectal cancer patients. HSP110 mutations are linked to microsatellite instability, which occurs in about 15 percent of all colorectal cancers. Microsatellite instability confers a more favorable outcome in most cases of colorectal cancer, though about one-third of such patients have Lynch syndrome, an inherited form of colorectal cancer that is linked to a higher risk of developing a second cancer.

Qiagen said that the HSP110 biomarker will complement its Therascreen tests to identify genetic mutations of the KRAS and BRAF genes in colorectal cancer patients.