AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE) is a multi-phase, multi-year, international data-sharing project that catalyzes precision oncology through the development of a regulatory-grade registry that aggregates and links clinical-grade cancer genomic data with clinical outcomes from tens of thousands of cancer patients treated at multiple international institutions.
AACR Project GENIE fulfills an unmet need in oncology by providing the statistical power necessary to improve clinical decision-making, particularly in the case of rare cancers and rare variants in common cancers. Additionally, the
registry will power novel clinical and translational research.
The data within GENIE will ultimately be shared with the global research community after defined periods of time. The project will also serve as a prototype for aggregating, harmonizing, and sharing clinical-grade, next-generation sequencing data obtained during routine medical practice.
GENIE is Unique
The registry already contains the existing CLIA-/ISO-certified genomic data obtained during the course of routine practice at multiple international institutions, and will continue to grow as more patients are treated at the participating centers. As a result, the registry is derived from a variety of cancer types, including rare cancers, and will be enriched in examples of late-stage disease, providing a “real world” dataset. Additionally, the registry only contains primary data and is not dependent on the curation of the published literature. Finally, unlike some health IT platforms and other large-scale projects, GENIE does not seek to improve the quality of routine cancer care or to assign patients to clinical trials as primary objectives.
One Registry, Many Uses
Powering clinical and translational research
Validating of biomarkers
Adding new mutations to existing drug labels*
Identifying new drug targets
Could provide the evidence base necessary to support reimbursement for next-generation sequence-based testing by payers.
*The AACR will be working closely with the FDA with the intention of building a regulatory-grade database such that the data could be accepted as the necessary evidence to gain regulatory approval.
Recognizing the need, urgency, and timeliness of such a project, the AACR provided the seed money for the first phase.
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