Dear Healthcare Provider,
AstraZeneca is closing the GenAssist testing program for germline genetic testing in early breast cancer patients on August 31, 2025.
In February 2024, in partnership with Invitae/Labcorp, AstraZeneca Canada and Merck Canada launched the GenAssist program to increase access to germline testing of high-risk breast cancer genes for Canadians diagnosed with early-stage breast cancer.
The shared objectives of this program were to:
- Increase equity of germline genetic testing across the country by providing testing to individuals diagnosed with early-stage breast cancer who met National Comprehensive Cancer Network (NCCN) criteria, but who did not meet their provincial criteria.
- Support identification of individuals for whom germline testing may guide surgical decision-making, inform prognosis and treatment pathways, and clarify familial risks.
- Generate evidence to advocate for broader and more equitable provincial germline testing criteria
Since its launch, approximately 325 Canadians have been enrolled in the GenAssist program. Together, we are proud that we have contributed to addressing a gap in access to germline testing in Canada—particularly for HR+ patients diagnosed over age 35 and TNBC patients diagnosed over age 50, who would have otherwise been missed by their provincial testing criteria.
While the number of individuals identified with a hereditary cancer risk has not yet been quantified, this data will be finalized in due course as part of a Real World Evidence study that complimented the testing program.
The GenAssist program will accept new patient enrollments until August 31, 2025. Any enrollment requests sent after August 31, 2025 will not be accepted. The GenAssist program will support testing of saliva samples received by Invitae/Labcorp until September 22, 2025. Patient samples received after September 22, 2025 will not be tested through the GenAssist program.
If you have questions about the closure of GenAssist, please contact the program by phone at 1-833-984-3983 or by email at support@genassistTSP.ca.
Thank you for your ongoing dedication to patient care and for your partnership in delivering meaningful diagnostic solutions for Canadians.
Sincerely, GenAssist Testing Support Program