QIAGEN for CDx
HILDEN, Germany—QIAGEN and Bayer HealthCare have agreed to collaborate to advance both companies' positions in personalized medicine. The joint effort will pair QIAGEN's companion diagnostic solutions with targeted therapies developed by Bayer HealthCare to enhance the treatment of patients with various solid tumors.
Neither the specific Bayer therapies nor the solid tumor types were revealed. The parties will also collaborate on the development of novel technologies for patient profiling which may result in innovative research use-only products for exploratory and translational medicine. The agreement provides a framework for further collaborations. Financial details were not disclosed.
Dr. Thomas Theuringer, QIAGEN's director of public relations, points out that "patient profiling for us means testing symptomatic patients to create or confirm diagnosis. Companion diagnostics tests pre-diagnose patients to guide treatments. Both can be based on the same technology, running on the same platforms. The challenge for CDx is not so much the development part. By linking the assay to a drug, regulatory approvals and successful commercialization create more of a challenge, which not many diagnostic companies can easily master."
QIAGEN cites recent estimates provided by Goldman Sachs that show molecular diagnostics to be the fastest growing segment in the $42 billion overall diagnostics market with an annual growth rate of 10 to 15 percent. "Likewise," Theuringer adds, "our revenues for personalized healthcare products continue to grow at solid double-digit rates."
The targeted companion diagnostics will be designed to run on the QIAsymphony family of automated instruments. When combined, the QIAsymphony SP and the QIAsymphony AS provide a fully integrated system that can automate complete workflows. Manual pipetting steps prone to human error are eliminated, helping to make this system attractive to laboratories that perform complex PCR assays on a day-to-day basis.
"We are very pleased to partner with Bayer HealthCare in developing companion diagnostics to improve life for cancer patients. As healthcare providers increasingly select the right drugs based on each individual's genomic information, the treatment of cancer is undergoing a revolution," said Dr. Helge Lubenow, senior vice president of QIAGEN's company's Molecular Diagnostics business unit and member of its executive committee. "The first collaborations for Bayer HealthCare and QIAGEN include companion diagnostics based on the identification of patients who may respond to therapies in clinically unmet disease classifications. Our agreement also lays the groundwork for a strong partnership in creating future companion diagnostics, both inside and outside of oncology."
"Partnering with QIAGEN on companion diagnostics will help Bayer HealthCare to develop innovative therapies, enabling physicians to analyze DNA and proteins from each patient. This helps to design more efficient clinical trials and to increase the overall probability of therapeutic success for patients suffering from cancer," adds Dr. Andreas Busch, head of global drug discovery and member of the executive committee of Bayer HealthCare.
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.