QIAGEN has had notable success globally in developing andvalidating companion diagnostics to guide the selection of medicines intreating 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 acompanion diagnostic in patients with metastatic colorectal cancer. The U.S.rollout of therascreen KRAS builds on a strong global track record thatincludes successes in Japan, where regulators approved the therascreen KRAS andEGFR kits in 2011 and in Europe, where QIAGEN offers 10 CE-marked assays forpersonalized healthcare applications. "The
therascreen KRAS assay and the therascreen EGFR kit are both based on the same RT-PCR technologyand both run on the same platform," says Theuringer. "A difference between thetwo 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 forcytological specimens," he notes.
The 10 CE-marked assays may indicate the immediateregulatory goals for QIAGEN in the U.S. and elsewhere. In addition to KRAS andEGFR kits, the European entries include assays for mutations of the BRAF gene, which has been found in cancers suchas
non-Hodgkin lymphoma,
colorectalcancer, malignant
melanoma,
papillary thyroid carcinoma,
non-small-cell lung carcinoma and
adenocarcinoma of the lung; NRAS kits thatcould be useful for initial identification of the gene in human neuroblastomacells, and finally, kits for the UGT1A1 gene that causes serious problems forbilirubin metabolism—leading in many cases to hyperbilirubinemea, particularlyamong East and Southeast Asian populations.
In addition to the Bayer HealthCare collaboration, QIAGEN has more than15 projects underway to co-develop and market companion diagnostics withleading pharmaceutical and biotech companies. The company employs approximately4,000 people in more than 35 locations worldwide.
