U.S. and European Immunologists Launch New Initiative to Improve Reliability and Interpretation of Data Derived from T cell-Based Immune Monitoring Assays

MIATA (Minimal Information About T cell Assays) Project Seeks Broad Participation and Consensus on the Construction of a Universally Accepted Reporting Framework

Newswise — The Cancer Research Institute (CRI), a U.S.-based nonprofit organization dedicated to harnessing the power of the immune system to treat, control, and prevent cancer, and the Association for Cancer Immunotherapy (CIMT), a European nonprofit organization based in Mainz, Germany, that aims to foster the development of cancer immunotherapies, announce the launch of a global, broad-based initiative to improve the reliability of reports of data derived from T cell-based immune monitoring assays, especially those used in the study of therapeutic vaccines for cancer and infectious diseases.

The initiative, called the Minimal Information About T cell Assays Project (MIATA Project), addresses a critical need within the scientific community to establish a framework for reporting immune monitoring data that promotes transparency and allows objective interpretation on how laboratories collect, analyze, interpret, and report data from T cell-based immune monitoring assays. Currently, no universally accepted guidelines exist to facilitate a meaningful interpretation and comparison of data from these assays. As a result, researchers view these data with skepticism and are often reluctant to accept conclusions based on them at face value.

Members of the CRI Cancer Vaccine Consortium (CVC), the CIMT Immunoguiding Program (CIP), and scientists from Stanford University comprise the core participants providing the initial momentum for the project. In their letter to the editors of the scientific journal Immunity published in the journal’s October 16 online edition and which the journal has made freely available on its Web site, the MIATA Project organizers detailed the project’s specific aims and invited members of the scientific community to participate in an extended public consultation and consensus-building process. The group has posted a comprehensive draft document online (www.miataproject.org), which will evolve over the next several months as they incorporate community feedback via the Web site and from discussion at several upcoming workshops and conferences.

According to the authors of the Immunity letter, the MIATA Project aims to establish a minimal reporting framework for five important variables known to influence the outcome of the three most commonly used T cell-based immune monitoring assays, namely ELISPOT, peptide-MHC multimer staining, and intracellular cytokine staining. The variables include: 1) how samples from the patient or donor are collected and handled; 2) how the assay was carried out; 3) how data from the assay is acquired and analyzed; 4) how results are evaluated and what their relationship is to the patient’s health; and 5) how the laboratory environment operates in terms of quality controls, staff training, adoption of standard operating procedures, and auditing processes, among other factors.

In their letter to Immunity, the authors stress that the reporting framework that will result from the MIATA Project is not intended to impose standards on how immune monitoring laboratories should carry out their assays. Rather, MIATA reporting standards should help to increase the transparency of published data so that readers can judge more confidently the quality of reported results.

The MIATA Project is patterned after similar, well-established minimal information frameworks for other biological research areas, including genome sequencing, flow cytometry, and protein functional evaluation. Many such guidelines are registered through the Minimal Information about Biological and Biomedical Investigations (MIBBI) portal (www.mibbi.org) and have become standard requirements for publication in many scientific journals.

In addition to providing the scientific community with a rigorously vetted set of MIATA reporting guidelines to facilitate the analysis of immune monitoring data, the MIATA framework will enable the systematic seeding of a public database for clinical immunomonitoring data. Currently, the lack of minimal reporting requirements renders the establishment of such a database impossible. According to the MIATA Project leaders, the creation of such a repository would benefit the community of researchers who rely on T cell-based immune monitoring assays and, ultimately, could accelerate the discovery, development, and regulatory approval of new prognostic biomarkers and effective, immune-based approaches to the treatment, control, and prevention of cancer and infectious diseases.

Reference Publication citation: http://www.cell.com/immunity/fulltext/S1074-7613(09)00419-1

About the Cancer Research Institute (CRI)

The Cancer Research Institute (CRI) is the world’s only non-profit organization dedicated exclusively to the support and coordination of scientific and clinical efforts that will lead to the immunological treatment, control, and prevention of cancer. Guided by a world-renowned Scientific Advisory Council that includes four Nobel Prize winners and twenty-nine members of the National Academy of Sciences, CRI supports leading-edge cancer research at top medical centers and universities throughout the world. CRI is an initiator and steward of global collaborative research efforts aimed at accelerating the translation of basic discovery into effective cancer vaccines and other immune-based therapies to provide new hope to cancer patients.

The Institute has one of the lowest overhead expense ratios among non-profit organizations, with more than 85 percent of its resources going directly to the support of its science, medical, and research programs. CRI meets or exceeds all 20 standards of the Better Business Bureau Wise Giving Alliance, the most comprehensive U.S. charity evaluation service, and according to Charity Navigator exceeds or meets industry standards and performs as well as or better than most cancer charities. CRI has also received an 'A' grade for fiscal disclosure and efficiency from the American Institute of Philanthropy as well as top accolades from other charity watchdog organizations. http://www.cancerresearch.org

About the CRI Cancer Vaccine Consortium (CVC)

The Cancer Vaccine Consortium is an international group of 72 pharmaceutical and biotech companies and academic institutions, who share a common goal of improving patient care by making cancer vaccines part of the standard-of-care in oncology. Member scientists, clinicians, and industry leaders exchange information with one another to analyze and establish solutions to common challenges in cancer vaccine use, development, and commercialization. The CVC has several working groups, including the ImmunoAssay Proficiency Program. The program aims to offer an external quality assurance program, and to enhance assay harmonization across immune monitoring laboratories. Since its inception five years ago, the program has successfully completed four proficiency testing rounds for ELISPOT, as well as two rounds for peptide-MHC multimer and intracellular cytokine staining. It is the largest proficiency testing program worldwide to include participants from academic, biotechnological, pharmaceutical, and governmental backgrounds.

The Consortium's membership of industrial and academic leaders across the United States, Canada, Japan, Australia, and Europe complements the CRI/LICR Cancer Vaccine Collaborative international network of academic clinical and laboratory centers. Working in parallel under the Cancer Research Institute, the two programs encompass all points along the cancer vaccine and immunotherapy development spectrum, from laboratory and clinical discovery, reagent production, and immune response monitoring, to therapeutic product development and approval. http://www.cancerresearch.org/CancerVaccineConsortium

About the Association for Cancer Immunotherapy (CIMT)

The Association for Cancer Immunotherapy (CIMT) is an information and education platform aiming to facilitate the development of new immunotherapies against cancer for the benefit of patients. CIMT was founded in 2002, and has its home office in Mainz, Germany. The association hosts the largest European expert meetings on cancer immunotherapy, publishes therapeutic guidelines and has established two topic-specific working groups: the CIMT Regulatory Research Party, focusing on the regulatory aspects of drug development, which has established itself as partner for European regulatory authorities; and the CIMT Immunoguiding Program (CIP), which focuses on the quality control and harmonization of immunomonitoring assays. To reach its goals, CIMT closely cooperates with various partners, among them the Cancer Research Institute’s Cancer Vaccine Consortium (CRI CVC). Visit www.c-imt.org for more information.

About the CIMT Immunoguiding Program (CIP)

CIP is chaired by C. Britten (Mainz, Germany), C. Gouttefangeas (Tübingen, Germany), and S. van der Burg (Leiden, NL), and comprises a network of 26 actively participating laboratories across Europe. The main objective of CIP is to establish high quality immunomonitoring assays to guide development of new immune therapeutics. With this aim, CIP organizes large proficiency panels to reach quality control and harmonization of commonly applied T-cell assays across institutions. This is made possible due to significant support from a research grant from the Wallace Coulter Foundation (Miami, Florida, USA). So far, CIP has focused on the enumeration of antigen-specific T cells by ELISPOT as well as MHC multimer and intracellular cytokine staining by flow cytometry. Results of testing phases are published in peer-reviewed journals and guidelines are freely available on the association's homepage.