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Qiagen, CMM to Co-Develop Tests for Breast Cancer, Other Women’s Diseases

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Qiagen plans to work with the Center for Molecular Medicine to discover biomarkers that could lead to diagnostics for breast cancer and other diseases that affect women.
 
The deal gives Qiagen access to CMM’s clinical samples, molecular capabilities, and database. CMM, a joint venture between the medical research organization Van Andel Institute and the Michigan-based healthcare-delivery system Spectrum Health, has a bioinformatics tool called XenoBase that enables researchers to conduct non-hypothesis-driven in silico biomarker discovery.
 
Spectrum Health sees 650,000 inpatients and outpatients annually in West Michigan. Additionally, the Van Andel Institute and Spectrum Health have a bank of disease specimens.
 
“CMM brings it all together by enabling testing of the resultant panels in a CLIA-certified, CAP-accredited … clinical diagnostics laboratory,” Daniel Farkas, CMM executive director, told Pharmacogenomics Reporter in an e-mail.
 
Financial terms of the agreement were not disclosed. Qiagen did not respond to a request for an interview before deadline.
 
In a statement, Grand Rapids-based CMM said its XenoBase database, developed at the Van Andel Research Institute by researchers Craig Webb and Jeremy Miller, is “at the center of the collaboration.”
 
The database “is capable of analyzing a wide range of molecular and conventional clinical data to help researchers identify clinically actionable associations between diseases, biomarkers, and treatments,” CMM said in a statement.
 
Although the partners didn’t provide a timeline for when the research might yield a commercially viable diagnostic, the collaboration fits with Qiagen’s recently stated goals to expand its molecular diagnostics portfolio, particularly in the area of women’s diseases.
 
This goal was strengthened last summer when Qiagen acquired Digene, which sells the only diagnostic for human papillomavirus approved by the US Food and Drug Administration.
 
The Deal
 
Neither CMM nor Qiagen elaborated on the types of biomarkers they were researching, though Farkas noted that the collaboration would begin by focusing on prognostic markers.
 
“Keep in mind that this non-hypothesis-driven research may yield markers that no one would have necessarily considered, but that XenoBase suggests, when grouped in a panel, may yield clinically actionable data for physicians managing patients with the condition of interest,” Farkas said.
 
The collaboration partners did not say when the research agreement would yield a commercial diagnostic. “When these data yield panels worthy of commercialization consideration, Qiagen will make the appropriate decisions on how to proceed,” Farkas said. “Work will begin immediately and the bioinformatics portion will move quickly.”
 

Based on the success of Qiagen’s initial research on CMM’s tools, CMM may also provide genomics and proteomics services to help Qiagen develop and validate new molecular diagnostic tests.

Based on the success of Qiagen’s initial research using CMM’s tools, CMM may also provide genomics and proteomics services to help Qiagen develop and validate new molecular diagnostic tests. CMM’s CLIA-certified diagnostics laboratory includes access to the XenoBase and has on-site microarray-based DNA typing and gene-expression profiling.
 
According to a statement from Qiagen Senior VP of Global R&D Joachim Schorr, the company is hoping that CMM’s technologies and services will help it “develop next-generation molecular markers for our long-term pipeline.”
 
In turn, Craig Webb, director of the translational medicine program at the Van Andel Institute, said he hopes that Qiagen’s expertise as a developer of diagnostic assays, combined with CMM’s suite of technologies, will “establish an accelerated means to introduce biomarkers into medical practice.”
 
Qiagen isn’t the only one who will make use of CMM’s suite of technologies and services in biomarker analyses. CMM last month announced that the Children’s Oncology Group will use CMM’s genotyping services as part of a Phase I study to investigate whether certain genetic abnormalities in children with leukemia are linked to treatment response or adverse events.
 
In this study, CMM will review 2,200 DNA samples from blood and leukemic blasts and catalog differences between the samples. “Once these genetic differences are identified, COG researchers will have information that can be adapted to improve diagnostic testing and zero in on methods to evaluate personalized therapeutics,” CMM said in a statement.
 
Qiagen’s Plans
 
Qiagen’s collaboration with CMM fits with its plan to grow its molecular diagnostics business, particularly in the realm of women’s diseases. Qiagen’s $1.6 billion acquisition of Digene, which it completed at the end of July, could help facilitate this goal.
 
“With the acquisition of Digene, we added an exciting new product portfolio in women's health to our molecular diagnostics franchise, which approximated Digene's size and growth rates prior to the acquisition,” said Qiagen CEO Peter Schatz during an investor call last week.
 
According to Schatz, the company’s molecular diagnostics business represents 50 percent of its current sales and represents a major sector of focus for future revenue growth. Qiagen launched 72 new technologies, including assays, in the area of gene-expression profiling, proteomics, and molecular diagnostics, which contributed to a 4-percent rise in net sales in 2007.
 
"Our full pipeline of new products and a strong strategic position build a solid basis for our success in 2008 and beyond,” Schatz said in a statement announcing financial results for the three months ended Dec. 31, 2007. During the period, Qiagen said revenues increased 67 percent to $210.2 million from $125.9 million in the fourth quarter of 2006.
 
Qiagen expects to make a number of new product introductions in 2008 and expand its sample and assay technology portfolio for research in applied testing and molecular diagnostics. “We are significantly investing in clinical trials for a number of molecular diagnostic products with the goal of adding more regulated products to our portfolio,” Schatz said.

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