General Electric and Celera Genomics this week disclosed the start of a long-term collaboration aimed at developing imaging agents that would help physicians identify certain cancers sooner and more accurately.
The deal, which will initially focus on four kinds of tumors and the proteins on the surface of cells, would also empower Celera Diagnostics to develop molecular diagnostics based on these agents, which could be used to identify at-risk populations or to pinpoint disease onset or severity.
The deal might also drive some steam into Celera Genomics’ nascent drug-discovery efforts by helping it develop therapeutic candidates against the validated agents.
“This collaboration complements our internal and partnered therapeutic programs, positioning us to make breakthrough discoveries and to convert them into products,” Kathy Ordoñez, president of Celera Genomics and Celera Diagnostics, said in a statement this week.
However, two reasons exist why investors and customers will likely wait at least 10 years before the alliance bears any fruit: Combining genomic and proteomic data with medical imaging technologies is still a new avenue in biotechnology; and GE’s early-focus Global Research division, rather than the conglomerate’s newly expanded Healthcare business, will be spearheading the project.
“This is about putting a couple of good research teams together,” said GE Research spokesman Troy Kirkpatrick. “The type of research that the collaboration deals with is longer-term, farther-out research.” He said the Research arm generally “look[s] in the five- to 10-year range,” after which time it hands off programs to GE’s individual business units — in this case, GE’s Healthcare Technologies business.
GE and Celera describe this deal as a “personalized medicine” alliance: GE would use cell surface proteins discovered in Celera’s proteomics shop during the past three years to develop agents that could be injected into a patient undergoing high-definition imaging scans. These agents would identify proteins on the surface of tumor cells, helping physicians to pinpoint and, eventually, characterize tumors.
“Our hope is that the proteins we have [can] lead to more selective and sensitive imaging tests,” Robert Bennett, a spokesman for Celera Genomics, told Pharmacogenomics Reporter in an e-mail message this week. “Earlier stage is the goal, [and] probably [positron emission tomography] and [computer tomography] are the best fits for platforms.”
“The ultimate goal will be earlier diagnosis,” agreed Kirkpatrick, who said imaging agents made by GE and Celera would be used with GE’s PET and CT instruments to detect cells that are beginning to become malignant. “Ideally, it would be diagnosing [cancer] before it became a tumor or lesion.”
What it means for Celera Diagnostics
Celera Diagnostics “can also come into play [by] identifying ‘at risk populations’ that can be screened through protein or imaging diagnostics for disease onset or severity,” Bennett added. He said Celera Diagnostics, a joint venture between Applied Biosystems and Celera Genomics, “could develop gene expression tests to characterize tumors or to predict drug response.”
Though this alliance focuses on pancreatic, lung, colon, and breast cancer, the biotechnology research programs ongoing at GE Global Research concentrate on cancer, cardiac diseases, and neurodegenerative diseases — particularly Alzheimer’s disease. This may play into Celera Diagnostics’ favor: Genetic tests being developed by the Applera unit for cardiovascular disease and Alzheimer’s may be taken up by GE in later portions of the imaging alliance, Ordoñez told Pharmacogenomics Reporter this week.
“You could imagine that if you could identify people who are at risk for cardiovascular disease or Alzheimer’s, then that might go hand in hand with imaging procedures,” she said.
Speaking of the cancer portion of the collaboration, Ordoñez said it is “really hard to predict” when the first of these agents will be commercialized, but said it is “certainly feasible in five years or perhaps even less.” Celera Diagnostics would be responsible for commercializing any genetic tests and even protein-based in vitro diagnostics developed for this collaboration. GE will have exclusive access to selected protein targets for researching and developing medical imaging agents. GE and Celera Genomics will share “certain responsibilities and costs” associated with research and development, as well as “value” from commercial products resulting from the project. Additional financial details were not disclosed.
What it means for GE
For GE, the alliance represents its first formal steps bringing together in vitro diagnostics and in vivo imaging. As the conglomerate was finalizing its acquisition of Amersham last fall and winter, officials from GE were touting the possibilities of combining these two disciplines while continuing to develop Amersham’s own molecular diagnostics programs — which could theoretically compete with Celera Diagnostics in certain areas, such as analyte-specific reagents sold as home-brew tests to clinical reference labs [see 4/14/03 PGx Reporter].
Specifically, one of GE’s goals following the acquisition was to enable physicians to integrate data from its imaging tools with information from the CodeLink platform. “The concept of being able to link together in vivo- and in vitro-based solutions, we think, is very powerful,” Trevor Hawkins, senior vice president of development and new business initiatives, said last April. “There’s in vivo imaging from the PET [scan], but there’s also information that has just come back from ... a SNP-based assay courtesy of CodeLink. We see that there’s going to be some great growth potentials here.”
For its Celera partnership, GE has simply substituted cell surface proteins for SNPs. (In the interview this week, Kirkpatrick, the GE Research spokesman, could not say whether GE might eventually bring into the collaboration any of Amersham’s pharmacogenomics assets. “It might be a little too early in our integration to know that,” he said.)
Ordoñez echoed this refrain in a statement announcing the GE partnership this week. Celera “share[s] GE’s commitment to the earlier detection and treatment of disease,” she said. “Coupling new in vitro diagnostics with in vivo imaging and targeted therapies should dramatically improve the diagnosis and treatment of disease.”
To be sure, the project is long term and it has just begun. Neither partner knows yet what form the imaging agents might take. One technology could be radio-labeled antibodies, in which an injectable imaging agent is composed of a radio-labeled substrate attached to a specific antibody, according to Michael Largen, a consultant with Largen Associates in Chapel Hill, NC. Bennett, the Celera spokesman, said radio-labeled antibodies will “most likely” be the technology that the partners pursue.
Far and Away?
To Largen, the collaboration is a “long-term play” because it requires identifying and validating markers. Celera Genomics will identify the markers, while Celera Diagnostics will likely have to validate them with academic collaborators, he said. “I don’t think GE has any kind of capabilities like that — even with the Amersham assets.
Bennett said Celera Diagnostics has already performed “a fair amount” of validation studies on existing cell surface proteins using immunohistochemistry and RNA interference methodologies. He added that Abbott will also be doing some validation studies for the company.
“I think that’s the missing piece,” said Largen. “Once you say you have a putative biomarker, then the work really begins in terms of validating that as a true biomarker.”
Still, Largen said a market for these kinds of imaging agents will exist when they become available. “When you think about surface markers, they become important” because they may allow you to perform biopsy diagnoses that can be better than existing morphological traits, and they can help researchers identify circulating tumor cells, he said. “That’s got value in terms of diagnostics and prognostics,” he added.