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DCIS Risk Assessment (Biomarker) Tests Explained

DCIS Risk Assessment

Biomarker Tests

There are currently two risk assessment tests available for Ductal Carcinoma in Situ (DCIS).

  • DCISionRT
  • Oncotype DX DCIS Score


A biomarker is any measurable indicator of what is happening biologically in the body.

In DCIS, biomarkers may include:

  • Gene expression (which genes are “turned on” or “off”)
  • Proteins (such as hormone receptors)
  • Mutations in tumor DNA

Why are they called biomarker tests?

They are called biomarker tests because they measure biological signals (biomarkers) within the DCIS tissue—many of which involve genes or gene activity.

In fact, genomic tests are a type of biomarker test.


What do these tests measure?

Both DCISionRT and Oncotype DX DCIS Score are considered genomic tests because they analyze patterns of gene expression in DCIS tissue.

These gene expression patterns act as biomarkers, providing important insights into:

  • Risk of recurrence
  • Likelihood of developing invasive breast cancer
  • Potential benefit of treatments such as radiation therapy

1. DCISionRT CPT® 0295U

DCISionRT is a genomic biomarker test developed specifically for DCIS.

It was created by PreludeDx and is based on research supported in part by the National Cancer Institute to better understand the biology of DCIS.

What the test does

DCISionRT combines:

  • Tumor biology (gene expression)
  • Clinical and pathologic factors

to generate a personalized risk assessment.

It provides:

  • A DCISion Score
  • A classification of Low Risk or Elevated Risk
  • An estimate of the likelihood of recurrence over 10 years

This information is designed to help patients and physicians make more informed, individualized treatment decisions.

DCISionRT Reclassifies Risk

Important: DCISionRT may reclassify risk

Research suggests that DCISionRT can significantly change risk assessment compared to traditional factors like tumor grade.

In one multi-site study of 474 patients:

  • 53% of patients with low or intermediate-grade DCIS were reclassified as Elevated Risk
  • 30% of patients with high-grade DCIS were reclassified as Low Risk

This highlights how tumor biology may differ from what traditional pathology alone suggests. Learn more here.

For more insights from a DCIS patient advocate, read Donna Pinto’s blog post: A New Bio-marker Test for DCIS = Peace of Mind for Thousands of Women

For questions on how the test is ordered and insurance, contact PreludeDX 

2. Oncotype DX DCIS Score®

CPT® 0045U

Oncotype DX DCIS Score is another genomic test developed specifically for DCIS.

What the test does

It provides a numerical score that estimates:

  • The likelihood of DCIS recurrence in the same breast
  • The potential risk of developing invasive breast cancer

Their home page shows a video explaining “Overtreatment” of DCIS 

 

Key Differences Between the Tests

  • Oncotype DX DCIS Score
    → Helps estimate your baseline risk of recurrence
  • DCISionRT
    → Provides a risk classification and is designed to help determine whether radiation therapy is likely to provide meaningful benefit


Genomic vs. Genetic Testing: What’s the Difference?

These terms are often confused but refer to very different types of testing.

Genomic Tests (Tumor Biology)

Genomic tests—like DCISionRT and Oncotype DX—analyze gene expression within the DCIS tissue taken from a biopsy or surgery.

They help answer:

  • How is this DCIS likely to behave?
  • What is the risk of recurrence or invasive cancer?

 

Genetic Tests (Inherited Risk)

Genetic tests evaluate inherited mutations, such as:

  • BRCA1
  • BRCA2

These tests help determine whether a person has a genetic predisposition to cancer, which affects overall lifetime risk—not just the current diagnosis.

 

Bottom Line

  • Biomarker tests measure biological signals in DCIS
  • Genomic tests are a type of biomarker test focused on gene activity
  • Genetic tests assess inherited cancer risk

Understanding these differences can help you make more informed, confident decisions about your care.

Understanding Your Pathology Report | 2024 Ductal Carcinoma In Situ Patient Forum  

Stuart Schnitt, MD, Chief of Breast Oncologic Pathology at Dana-Farber Brigham Cancer Center, discusses pathology reports at the second annual Ductal Carcinoma In Situ Patient Forum May 18, 2024. says: DCIS is not “cancer”; it’s more like a pre-cancer.

He explains the two biomarker tests for DCIS at 18:08 minutes.