"We are the leader in the commercialization of metabolomics, with a profitable commercial life-sciences service business, and have launched the world's first metabolomics-based diagnostic test for type 2 diabetes risk based on biomarkers that measure insulin resistance," said Metabolon CEO Dr. John Ryals in announcing the acquisition. "We expect that in 2013, we will be marketing additional diagnostic products aimed at diseases related to obesity and cancer, and are committed to maintaining our position as the world's leader in metabolomics."  

 

Companies like Ezose Sciences, based in Pine Brook, N.J., meanwhile, are attempting to leverage expertise in glycomics and the company's GlycanMap platform as the basis of a diagnostics pipeline. In April, the company announced a collaboration with Hirosaki University to identify potential glycomic biomarkers to predict and monitor prostate and other urological cancers.  

 

And even cellomics has started to make inroads into the biomarker world. Also presenting at the Markers in Cancer Meeting, researchers from Durham, N.C.-based Argos Therapeutics discussed efforts to identify cell-surface signatures for patient response to its immunotherapy candidate AGS-003 in patients with metastatic renal cell carcinoma.

 

Argos researchers applied informatics methodology more commonly used in microarray analysis to flow cytometry of cytotoxic T cells and identified combinatorial expression patterns of cell surface markers that correlated with superior outcomes in patients receiving AGS-003 and sunitinib. By parsing the data even further, they were able to identify other biomarker signatures, which they described as markers of immune function, or MIFs, and tightly correlated with progression-free survival and overall survival outcomes in the study patients.  

 

Driven by data  

 

The inherent complexity of these signatures, however, increases the need for informatics solutions to help distinguish the signal from the noise in identifying true signatures. Unlike the HER2 tests, we are no longer looking at a simple binary yes-no answer.

Researchers aren't just limiting themselves to 'omics data, either.

 

"While the in-vitro signature—e.g., genetic biomarkers—is important, the in-vivo stage—e.g., imaging—is also very important to getting a complete answer," says Brophy. "The question then becomes how do you combine data from a variety of sources such as electronic medical records (EMRs), pathology, radiology, etc."

 

For GE Healthcare—which has extensive expertise in medical imaging methodologies such as PET, MRI and CT scans—part of the answer came in moving that expertise into the world of pathology.  

 

"The digitization of radiology revolutionized that field, and we feel the time is now right to digitize pathology and take it from a subjective art to an objective science," Brophy adds. "This would give pharma a quantitative tool to monitor the performance of a drug on pathology slides, rather than rely solely on the qualitative analysis of a pathologist."  

 

To that end, GE Healthcare recently launched Omnyx, a joint venture with the University of Pittsburgh Medical Center (UPMC). According to Brophy, UPMC brings an extensive collection of annotated tissue slides and offers Omnyx access to a constant influx of thousands of patients each year. The focus is on cancer diagnostics and developing systems where clinicians and pathologists can store, retrieve, annotate and share data easily and quickly with colleagues.  

 

"While the scanner is the most obvious component, the software interface and back end is key to the system," he adds. "And of course, the challenge is in not just developing a tool that reflects what the pathologist is doing now, but also how they will be working in the future."  

 

"Clinical diagnostics are not new—people have been performing urine tests or blood work for years," adds Trish Meek, director of life-sciences product strategy at Waltham, Mass.-based Thermo Fisher Scientific Inc. "The challenges of molecular diagnostics, however, are quite unique as researchers try to perform standard assays, while always incorporating new technologies and techniques into their practice."  

 

As its clients' needs evolved, Thermo Fisher Scientific extended its knowledge with lab information systems (LIS) and lab information management systems (LIMS) into helping pharma customers with biomarker identification and validation—and ultimately into research hospitals.  

 

"We work with the customer to take them beyond the traditional LIS, so our job is still about operations on one side, but it is also about making sure the information is clear and actionable on the other," says Meek. "That's why we developed the web-based interface for the end user."  

 

As biomarker signatures become more complex, pharma companies are likely to rely more heavily on their diagnostic partners and can expect a significant shift in the clinical trials landscape.  

 

"Biomarker validation will become an increasingly important part of the clinical trial process," Brophy offers. "As pharma companies approach the Phase IIb trial of their new drug without a marker, they may begin to get worried that they don't have a companion diagnostic."  

 

GE Healthcare's 2010 acquisition of molecular diagnostics specialist Clarient, which is based in Aliso Viejo, Calif., was a step toward addressing this need.

 

 

"GE and Clarient are in a number of discussions with pharma companies as to how we can help, leveraging our CLIA-certified labs to identify, develop and validate these diagnostic resources," adds Brophy.

 

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