BOSTON — The American Association for Cancer Research (AACR) today announced the launch of an international initiative known as AACR Project Genomics, Evidence, Neoplasia, Information, Exchange (GENIE). The initial phase of the project, which is being conducted in partnership with seven global leaders in genomic sequencing for clinical utility, as well as two informatics partners, will aggregate participants’ clinical-grade sequencing data to improve patient treatment decisions and catalyze clinical and translational research.
The seven founding members of the consortium and phase 1 participants are:
- The Center for Personalized Cancer Treatment, Utrecht, Netherlands;
- Dana-Farber Cancer Institute, Boston;
- Institut Gustave Roussy, Villejuif, France;
- Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center, Baltimore;
- Memorial Sloan Kettering Cancer Center, New York;
- Princess Margaret Cancer Centre, Toronto; and
- Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.
The two informatics partners are:
“The need for AACR Project GENIE is great,” said Charles L. Sawyers, MD, AACR Project GENIE Steering Committee chairperson, 2015-2017. “Numerous factors are driving an increase in the amount of genomic data available for analysis; however, these data are typically insufficient in number or lack the necessary clinical outcomes data to be clinically meaningful. Thus, to effectively benefit patients, the genomic and clinical outcomes data from as many institutions as is practical should be combined through a data-sharing initiative, such as AACR Project GENIE.”
AACR Project GENIE will accomplish its goals by pooling existing and ongoing Clinical Laboratory Improvement Amendments (CLIA)- and International Organization for Standardization (ISO)-certified sequencing data from the participating institutions into a single registry and linking these data with select longitudinal clinical outcomes [see infographic (PDF)]. All project data will be made open-access following defined periods of project exclusivity, and the initial genomic data set will be publicly available on Nov. 6, 2016.
The AACR Project GENIE registry already contains more than 17,000 genomic records. This registry is unique in that it is enriched in late-stage cancers and contains only clinical-grade sequencing data on which clinical decisions have been made. More importantly, the number of genomic records in the AACR Project GENIE registry will continue to grow as new patients are seen at each participating institution and subsequently added to the registry. The approach to data harmonization is such that each participating organization can continue to operate how it best sees fit while simultaneously contributing its data to the project. In this manner, future participants can and will be easily added once the pilot phase of the project is concluded.
“Data-sharing projects are crucial because they connect data producers, mainly doctors from hospitals, and data analysts who are bioinformaticians and biologists,” said Fabrice André, MD, PhD, professor, Institut Gustave Roussy, and AACR Project GENIE Steering Committee member. “The beauty of data-sharing projects is that they are universal and allow anyone in the world to work on biology projects based on a common data set. This is extremely exciting for a medical doctor to run projects that will serve the community of researchers across the world. AACR Project GENIE is a unique resource that will accomplish this.”
The AACR Project GENIE registry is a tool that can be used to solve a multitude of clinical and research challenges. There are myriad ways in which the project can benefit patients, including: the validation of gene signatures of drug response or prognosis; the ability to identify new patient populations for previously U.S. Food and Drug Administration (FDA)-approved drugs; the expansion of patient populations that will benefit from existing drugs; and the identification of new drug targets and biomarkers.
“I am extremely proud that the AACR is serving as the coordinating center for AACR Project GENIE,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “As a highly respected scientific, not-for-profit international organization, the AACR is uniquely suited to play such a critical role in this important precedent-setting project. We will also be marshaling the collective wisdom of our membership, as well as leveraging our close relationships with the FDA, the National Cancer Institute, and the Global Alliance for Genomics and Health, to ensure the success of the project for the benefit of cancer patients everywhere.”