Genomic Testing

Gene profile testing, which is done by microarray assay or reverse transcription-polymerase chain, is done for breast cancers. For Breast, there are several Genomic testing data items. These are called Site-Specific Data Items (SSDIs), and are collected for each case.

Data Item NAACCR Item # NAACCR Text Field #
Oncotype Dx Recur Score-Invasive 3904 2570: Text-Dx Proc Path
Oncotype Dx Risk Level-Invasive 3906 2570: Text-Dx Proc Path
Oncotype Dx Recur Score-DCIS 3903 2570: Text-Dx Proc Path
Oncotype Dx Risk Level-DCIS 3905 2570: Text-Dx Proc Path
Multigene Signature Method 3894 2570: Text-Dx Proc Path
Multigene Signature Result 3895 2570: Text-Dx Proc Path

See Schemas | SSDI and Grade DataExternal Website Policy for the SSDI manual and the schema information or SEER*RSA in the Breast schema for complete coding instructions for these data items.

Note: For the SSDIs, it is very important that you read the general instructions (see NAAACR link above) first. For example, the general instructions tell you how to code when there is a range, when “less than” or “greater than” is used. After the general instructions are reviewed, you move to the data specific instructions.

There are two main gene profiles that are done

Oncotype: The Oncotype DX 21 gene assay is the gene profile test with the most extensive clinical validation thus far and applies to hormone receptor-positive (ER and/or PR+), HER2-negative breast cancer.

MammaPrint: This was the first gene profile test to be approved by the U.S. Food and Drug Administration. The 70-gene signature classifies tumors into high-risk and low-risk prognostics categories.

  • MammaPrint Results are documented in two data items
    • Multigene Signature Method [NAACCR Item # 3894]
    • Multigene Signature Results [NAACCR Item # 3895]

There are three additional minor gene profiles

The minor gene profiles are also found in the Multigene Signature Method and Multigene Signature Results SSDIs, and collect information on the following.

Updated: January 10, 2025