Neither the specific Bayer therapies nor the solid tumortypes were revealed. The parties will also collaborate on the development ofnovel technologies for patient profiling which may result in innovativeresearch use-only products for exploratory and translational medicine. Theagreement provides a framework for further collaborations. Financial detailswere not disclosed.
Dr. Thomas Theuringer, QIAGEN's director of publicrelations, points out that "patient profiling for us means testing symptomaticpatients to create or confirm diagnosis. Companion diagnostics tests pre-diagnosepatients to guide treatments. Both can be based on the same technology, runningon the same platforms. The challenge for CDx is not so much the developmentpart. By linking the assay to a drug, regulatory approvals and successfulcommercialization create more of a challenge, which not many diagnosticcompanies can easily master."
QIAGEN cites recent estimates provided by Goldman Sachs thatshow molecular diagnostics to be the fastest growing segment in the $42 billionoverall diagnostics market with an annual growth rate of 10 to 15 percent. "Likewise,"Theuringer adds, "our revenues for personalized healthcare products continue togrow at solid double-digit rates."
The targeted companion diagnostics will be designed to runon the QIAsymphony family of automated instruments. When combined, theQIAsymphony SP and the QIAsymphony AS provide a fully integrated system thatcan automate complete workflows. Manual pipetting steps prone to human errorare eliminated, helping to make this system attractive to laboratories thatperform complex PCR assays on a day-to-day basis.
"We are very pleased to partner with Bayer HealthCare indeveloping companion diagnostics to improve life for cancer patients. Ashealthcare providers increasingly select the right drugs based on eachindividual's genomic information, the treatment of cancer is undergoing arevolution," said Dr. Helge Lubenow, senior vice president of QIAGEN's company'sMolecular Diagnostics business unit and member of its executive committee. "Thefirst collaborations for Bayer HealthCare and QIAGEN include companiondiagnostics based on the identification of patients who may respond totherapies in clinically unmet disease classifications. Our agreement also laysthe groundwork for a strong partnership in creating future companiondiagnostics, both inside and outside of oncology."
"Partnering with QIAGEN on companion diagnostics will helpBayer HealthCare to develop innovative therapies, enabling physicians toanalyze DNA and proteins from each patient. This helps to design more efficientclinical trials and to increase the overall probability of therapeutic successfor patients suffering from cancer," adds Dr. Andreas Busch, head of globaldrug discovery and member of the executive committee of Bayer HealthCare.
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.