QIAGEN has had notable success globally in developing and validating companion diagnostics to guide the selection of medicines in treating cancer and other diseases. In July 2012, the company received U.S. Food and Drug Administration approval for the therascreen KRAS RGQ PCR Kit as a companion diagnostic in patients with metastatic colorectal cancer. The U.S. rollout of therascreen KRAS builds on a strong global track record that includes successes in Japan, where regulators approved the therascreen KRAS and EGFR kits in 2011 and in Europe, where QIAGEN offers 10 CE-marked assays for personalized healthcare applications. “The therascreen KRAS assay and the therascreen EGFR kit are both based on the same RT-PCR technology and both run on the same platform,” says Theuringer. “A difference between the two products is that the EGFR kit covers more mutations than the KRAS assay. The EGFR test launched in Japan 2011 is approved only for FFPE samples, not for cytological specimens,” he notes.  

 

The 10 CE-marked assays may indicate the immediate regulatory goals for QIAGEN in the U.S. and elsewhere. In addition to KRAS and EGFR kits, the European entries include assays for mutations of the BRAF gene, which has been found in cancers such as non-Hodgkin lymphoma, colorectal cancer, malignant melanoma, papillary thyroid carcinoma, non-small-cell lung carcinoma and adenocarcinoma of the lung; NRAS kits that could be useful for initial identification of the gene in human neuroblastoma cells, and finally, kits for the UGT1A1 gene that causes serious problems for bilirubin metabolism—leading in many cases to hyperbilirubinemea, particularly among East and Southeast Asian populations.  

In addition to the Bayer HealthCare collaboration, QIAGEN has more than 15 projects underway to co-develop and market companion diagnostics with leading pharmaceutical and biotech companies. The company employs approximately 4,000 people in more than 35 locations worldwide.