Transparency Submission

FDA Clearance: not applicable

Rationale for Requested Change: The systematic literature review performed by the ASCO-SSO expert panel found sufficient evidence to develop recommendations and publish a guideline pertaining to germline testing in individuals with breast cancer. The recommendations developed by this panel specifically recommend offering BRCA1/2 testing to all patients diagnosed with breast cancer <65 yo (Recommendation 1.1). This recommendation is more inclusive than the current NCCN guideline and is supported by the expert panel conclusion that the ideal balance of sensitivity and specificity was reached at a testing age threshold of 65. The working group recommended that testing be offered to patients with breast cancer diagnosed over age 65 (Recommendation 1.2) who meet specific criteria. This recommendation aligns with current NCCN testing criteria. While the ASCO-SSO guideline and review primarily focused on BRCA1/2, it also recommended that appropriate patients undergoing testing should be offered testing for other high penetrance breast cancer genes (Recommendation 4.1), and may be offered testing for moderate penetrance genes (Recommendation 4.2). However, in clinical practice multi-gene panel testing includes an array of genes as noted in the table on page Gene A of the NCCN guidelines.These ASCO-SSO recommendations are consistent with current NCCN testing criteria. Thus to avoid confusion among practitioners, particularly the growing number of non-genetics medical and surgical oncology practitioners ordering point-of-care genetic testing, we ask the NCCN panel to update the guideline with the proposed suggestion to align with ASCO-SSO.