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NCI-CPTC, AACC Agreement Aims to Advance Proteomics in Clinical Labs

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The story originally ran on March 9 and has been updated to include information about an additional MOU.

By Tony Fong

In another step aimed at intertwining clinical chemistry more closely with clinical proteomics, the National Cancer Institute's proteomics program and the American Association of Clinical Chemistry have entered into a memorandum of understanding to co-promote proteomics technologies and standards in the clinical chemistry community.

The MOU, announced last week, aims to take proteomics where it has rarely been — the clinical chemistry lab. It also seeks to encourage proteomics researchers to adopt procedures and processes that are routinely practiced in clinical chemistry labs.

Separately, NCI-CPTC and the Korea Institute of Science and Technology this week announced an MOU to "promote proteomic technology optimization and standards implementation in large-scale international programs."

The MOU with AACC seeks to extend formal programmatic and scientific collaborations between AACC and NCI-CPTC "in order to facilitate the two organizations fulfilling their individual missions," Saeed Jortani, chairman of the AACC Proteomics division, which was officially created on Jan. 1, told ProteoMonitor last week.

"Our organization has spent quite a lot of time with NCI getting them to understand and recognize the value of clinical chemists and clinical laboratories when it comes to translating biomarkers," said Jortani.

The partners have laid out four principles and guidelines: research and education; "exchange of information, research, and data;" the development and use of proteomics technologies for use in clinical applications; and mutual collaborations with industry, academia, government entities, and other non-profits.

In an e-mail to ProteoMonitor, Henry Rodriguez, director of NCI-CPTC, said that as his organization proceeds to build out the proteomics standards and technology pipeline, partnering with the AACC "will serve to further translate efforts in proteomics, while sharing ideas and processes leading to the standardization, reproducibility, and accuracy of proteomics as a science."

The MOU does not stipulate financial commitments or specify projects to be carried out by the two parties. Rather, the AACC and NCI-CPTC will decide on work to be done based on "what comes up next."

For example, "what we are foreseeing is instrument/technology platform validation," which could be done by members of AACC, Jortani said. "The MOU records the intent of parties to collaborate in these areas."

The MOU also should make it easier for officials from one group to speak at meetings and events organized by the other. For instance, the AACC had to "go through different various channels" for NCI officials to speak at AACC events — a process Jortani called "very difficult." Now, with the MOU in place, such an agreement would be completed in "a very fast process," he said.

The MOU also simplifies the task of collaborating on studies, and researchers from the AACC and NCI-CPTC are currently preparing research papers on "various different aspects of translation of … novel biomarkers into clinical practice," according to Jortani.

He said that the MOU, which is for five years, highlights the importance of involving both parties in future decisions to be made about translational proteomics. The NCI could throw all its resources into biomarker discovery and validation, but without involving entities such as the AACC, "the challenges that are required to bring those [datasets] to clinical practice are not going to be dealt with," he said.

Jortani said an official relationship with NCI-CPTC could also open, even if slightly, a doorway to more National Institutes of Health funding for clinical chemists. While the MOU's emphasis is on educational seminars and sessions, Jortani said that he hopes that "possibly in the future we would have" requests for applications, and that the NCI "would recognize the value of the clinical laboratories in this process and … actually help us out in studying these challenges through specific requests for proposals."

And while the agreement makes no promises — MOUs by definition are not contractual or binding — he stressed that by interacting with clinical chemists on a regular basis the NIH could gain a better understanding of what they do.

Indeed, at an AACC meeting last fall focusing specifically on proteomics, speakers said that while scientific discovery has a strong history of financial support from government, researchers focusing on translating those discoveries into practice have had to rely on the private sector for funding [See PM 11/13/09].

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Courting Clinical Proteomics

The MOU comes as the proteomic and clinical chemistry communities have increasingly been trying to move proteomics into the clinic by leveraging each other's know-how and capabilities.

For as long as proteomics has existed, researchers in the field and in clinical chemistry have worked in isolation from each other. Indeed, they didn't see much use for one another. But as protein biomarker research thickens into a preclinical quagmire, the proteomics community has slowly begun to appreciate the benefits that clinical chemists can bring to the bench.

Likewise, although the number of protein-based clinical assays approved by the US Food and Drug Administration remains negligible, the number of home-brewed protein-based tests has been increasing in recent years, making it difficult for clinical chemists to dismiss proteomics as a backwater discipline.

This notion gained momentum in January when proteomics became a permanent division within AACC, perhaps signaling the field's growing importance in clinical chemistry. In the fall, a spokesman for the organization said that being granted permanent status indicates that the "parochial interest" of proteomics researchers is "also [of] interest to clinical chemists as a whole, and that they are a more solid part of the clinical laboratory community." [See PM 11/06/09]

And last month, a new organization, the Association for Mass Spectrometry: Applications to the Clinical Laboratory, held its first conference, which included sessions devoted to clinical proteomics [See PM 02/12/10].

The MOU caps efforts over the past few years by the AACC and NCI-CPTC aimed at seeing how the two groups can leverage each other's expertise for mutual benefit.

In his e-mail, NCI-CPTC's Rodriguez said that in the three and a half years of his group's history, it "has successfully pursued and achieved nearly all of the goals of building a firm foundation for the field of proteomics." This includes "building a network of academic institutions and leaders in proteomics who are working to develop standards for and testing technologies used in the field." [See PM 09/28/06]

He cited work done by CPTC's Clinical Proteomic Technology Assessment for Cancer initiative in multiple-reaction-monitoring mass spectrometry. "Proteins can now confidently be measured sensitively and quantitatively in a high-throughput, multiplex manner on instruments that are already deployed in academic and clinical laboratories," he said [See PM 07/09/09].

Integration is necessary now in order to push science and technology forward, and "the strengths of the NCI in advancing the science of proteomics … and [of] AACC in improving healthcare through laboratory medicine offer the opportunity for organizational synergy that will accelerate proteomics technology development and application in clinical settings," he said.

Separately, his organization said that it and the Korea Institute of Science and Technology are partnering to improve proteomics technology and encourage the implementation of standards in large-scale international efforts. In a statement, NCI-CPTC said "The MOU framework will enable and encourage the sharing of knowledge and support the formation of research teams to solve complex problems in the area of each organization's mission."

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