Transparency Document
NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic V.1.2025
| Request Number | Guideline Page | Specific change request | Panel Decision | Comment | Institution Vote |
|---|---|---|---|---|---|
| 4558 | CRIT-2 ODX RS Submitted by AstraZeneca on 05-19-23 | Under the “any age” bullet - add “ODX RS intermediate or high” to the testing criteria for high-penetrance breast cancer susceptibility genes | Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |
|
| 2308 |
CRIT-7
Phyllodes tumor Submission from Mercy Hospital on 11-13-2023 |
Add bullet point:
-Individual with prior phyllodes tumor found on pathology
|
Change not made, panel supported alternate language | Bullet added to CRIT-3 (Testing may be considered): Personal history of malignant phyllodes tumors |
Yes: 0 No: 32 Abstain:0 Absent:2 |
| 3839 |
Page: TNBGD 1-4
MCED Submission from GRAIL on 03-23-2024 |
For screening/surveillance for transgender, non-binary, and gender diverse people with hereditary cancer syndromes - Focus on those organs at risk based on biologic sex at birth and have not been surgically removed - Ovarian cancer - Uterine cancer Add: Consider multi-cancer early detection (MCED) test screening annually New Footnote: Multi-cancer early detection (MCED) testing is a non-invasive screening test available by prescription, for individuals with an elevated risk for cancer. When a MCED test result is Cancer Signal Detected, immediate diagnostic evaluation based on predicted Cancer Signal Origin(s) is recommended. |
Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |
|
| 3838 |
Page: COWD-A 1-2 OF 2
MCED Submission from GRAIL on 03-23-2024 |
For screening/surveillance for Cowden Syndrome/PTEN Hamartoma Tumor Syndrome - Colorectal cancer - Endometrial cancer Add: Consider multi-cancer early detection (MCED) test screening annually New Footnote: Multi-cancer early detection (MCED) testing is a non-invasive screening test available by prescription, for individuals with an elevated risk for cancer. When a MCED test result is Cancer Signal Detected, immediate diagnostic evaluation based on predicted Cancer Signal Origin(s) is recommended. |
Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |
|
| 3837 |
Page: LIFR-A 4-5 OF 6
MCED Submission from GRAIL on 03-23-2024 |
For screening/surveillance for Li-Fraumeni Syndrome (P/LP TP53 Variant): Adult Surveillance - Other cancer risks - Other aspects of managing LFS Add: Consider multi-cancer early detection (MCED) test screening annually New Footnote: Multi-cancer early detection (MCED) testing is a non-invasive screening test available by prescription, for individuals with an elevated risk for cancer. When a MCED test result is Cancer Signal Detected, immediate diagnostic evaluation based on predicted Cancer Signal Origin(s) is recommended. |
Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |
|
| 3836 |
Page: PANC-A 1-2 OF 2
MCED Submission from GRAIL on 03-23-2024 |
For pancreatic cancer screening in select individuals at increased risk for exocrine pancreatic cancer: - All individuals with P/LP germline variants in STK11 - All individuals with P/LP germline variants in CDKN2A - Individuals with P/LP germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53) - Hereditary Pancreatitis Genes Add: Consider multi-cancer early detection (MCED) test screening annually New Footnote: Multi-cancer early detection (MCED) testing is a non-invasive screening test available by prescription, for individuals with an elevated risk for cancer. When a MCED test result is Cancer Signal Detected, immediate diagnostic evaluation based on predicted Cancer Signal Origin(s) is recommended. |
Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |
|
| 3835 |
Page: BRCA-A 1-5 OF 5
MCED Submission from GRAIL on 03-23-2024 |
For screening/surveillance in each Cancer Type associated with BRCA-Pathogenic/Likely Pathogenic Variant: - Ovarian/ Fallopian Tube/ Peritoneal/ Uterine Cancers - Pancreatic cancer - Prostate cancer - Melanoma Add: Consider multi-cancer early detection (MCED) test screening annually New Footnote: Multi-cancer early detection (MCED) testing is a non-invasive screening test available by prescription, for individuals with an elevated risk for cancer. When a MCED test result is Cancer Signal Detected, immediate diagnostic evaluation based on predicted Cancer Signal Origin(s) is recommended. |
Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |
|
| 3834 |
Page: GENE-A 1-11 OF 11
MCED Submission from GRAIL on 03-23-2024 |
For Pancreatic Cancer Risk and Management and Other Cancer Risks, for each Gene with risk or increased risk: - ATM - BRCA1 - BRCA2 - CDH1 - CDKN2A - CHEK2 - MSH2, MLH1, MSH6, PMS2, EPCAM - NF1 - PALB2 - PTEN - STK11 - TP53 Add: Consider multi-cancer early detection (MCED) test screening annually New Footnote: Multi-cancer early detection (MCED) testing is a non-invasive screening test available by prescription, for individuals with an elevated risk for cancer. When a MCED test result is Cancer Signal Detected, immediate diagnostic evaluation based on predicted Cancer Signal Origin(s) is recommended. |
Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |
|
| 3833 |
Page: GENE-A 1-11 OF 11
MCED Submission from GRAIL on 03-23-2024 |
For Epithelial Ovarian Cancer Risk and Management, for each Gene with risk or increased risk: - ATM - BARD1 - BRCA1 - BRCA2 - BRIP1 - CDH1 - CDKN2A - CHEK2 - MSH2, MLH1, MSH6, PMS2, EPCAM - NF1 - PALB2 - PTEN - RAD51C - RAD51D - STK11 - TP53 Add: Consider multi-cancer early detection (MCED) test screening annually. New Footnote: Multi-cancer early detection (MCED) testing is a non-invasive screening test available by prescription, for individuals with an elevated risk for cancer. When a MCED test result is Cancer Signal Detected, immediate diagnostic evaluation based on predicted Cancer Signal Origin(s) is recommended. |
Change not made, additional data needed |
Yes: 0 No: 26 Abstain:0 Absent:7 |