Date: 2015-04-21
Type of information: Collaboration agreement
Compound: BRCA Share™
Company: Quest Diagnostics (USA - NY) Inserm (France) Inserm Transfert (France)
Therapeutic area: Cancer - Oncology - Technology - Services
Type agreement: collaboration
Action mechanism: BRCA Share builds on a BRCA gene-data curation process developed by Inserm with BRCA data, maintained in its Universal Mutation Database, developed over a decade of patient testing by 16 laboratories in France that make up, together with associated University Hospital Centers, the Unicancer Genetic Group (UGG).
Disease: breast cancer, ovarian cancer
Details: * On April 21, 2015, Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, Inserm, launched BRCA Share™, a novel datashare initiative they co-founded to provide scientists and laboratory organizations around the world with open access to BRCA1 and BRCA2 genetic data. The program\'s goal is to accelerate research on BRCA gene mutations, particularly variants of uncertain significance, to improve the ability of clinical laboratory diagnostics to predict which individuals are at risk of developing hereditary breast and ovarian cancers. Laboratory Corporation of America® Holdings (LabCorp®) is the first participant in the initiative, which is structured as a user group.
Members of BRCA Share will pool de-identified clinical laboratory patient data on BRCA1 and BRCA2. Although several mutations of BRCA1 and BRCA2 genes are established as cancer causing, there are instances when a patient receives an indeterminate test result because the individual\'s genetic information reveals a gene variant of uncertain significance (VUS). Greater insight into the cancer risk of VUS will reduce the potential for indeterminate test results, leading to improvements in risk-assessment for certain cancers.
BRCA Share provides several features unique to a gene datashare program. BRCA Share is a public-private initiative through which commercial entities will fund the program on a sliding scale to encourage participation from labs of all sizes; in the U.S., this obviates the need for government funding. Research entities and individuals with a research-only focus on BRCA can participate at no charge. BRCA Share is also believed to be unique in its focus on functional studies to which commercial participants will contribute. These studies are designed to determine the pathogenicity of BRCA variants of uncertain significance. The program is also based on an established data VUS interpretation performed by geneticists of the sixteen UGG laboratories. Data curation, which includes review of shared data for duplicate entries and confirmation that all data provided meets the same level of scientific rigor, is imperative to ensure data can be used for commercial applications as well as for research. Inserm developed the UMD software over several years and this system was applied to many different genetic diseases.
Under BRCA Share, all members will have access to the same pool of jointly contributed BRCA data. Quest Diagnostics will license BRCA data, including from Inserm\'s UMD-BRCA1/2 databases, and form sublicense agreements with any commercial lab or academic party that commits to share BRCA data with the group\'s members. User group members will also establish processes for reporting new findings to members, which commercial labs may use to update their clinical test reports for patients, including those whose prior test results may have been indeterminate. Quest and LabCorp are actively recruiting additional participants.
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