Effective August 2, 2022, mdxhealth has acquired the Oncotype DX Genomic Prostate Score (GPS) test from Exact Sciences. Additionally, Genomic Health Inc, part of Exact Sciences, will continue to perform the GPS test during the transition. Further communications explaining transition plans will be provided in the coming months. For more details, please review the press release.
Questions? Email: gps@mdxhealth.com

Clinical Evidence

Over 1/3 of patients had a change in treatment recommendation after an Oncotype DX Breast DCIS Score® test.7

Right approach to treatment. Right when they need it.

Findings from the Duchess study led to changes in treatment decisions and reduced recommendations for radiation therapy—helping patients avoid overtreatment.1

  • After Breast DCIS Score® testing, 35% of patients had a change in treatment recommendation
  • Radiation therapy recommendations dropped from 79% to 50% after testing
  • Testing was associated with improved patient satisfaction and reduced decisional conflict
In addition, 2 decision impact studies demonstrated that integration of the DCIS Score® result changed treatment recommendations. The studies showed that clinicians changed their recommendations approximately 30% of the time.2,3
The Breast DCIS Score test is a clinically validated, commercially available genomic test for patients with DCIS.

About the DCIS studies

Two validation studies confirm that the Oncotype DX Breast DCIS Score test determines the 10-year risk of local recurrence.

Studies involved 1,587 patients

Studies showed that clinicians could more accurately assess patient risk with the Breast DCIS Score test than with traditional assessment methods (such as clinical and pathologic factors or nomograms) alone1,4,5

These studies confirmed that the DCIS Score result1,4,5:

  • Reveals the 10-year risk of local recurrence in patients with DCIS who underwent breast-conserving surgery with or without XRT
  • Is significantly associated with risk of an invasive local recurrence
  • Is significantly associated with risk of a DCIS local recurrence

 

Meta-analysis of validation studies

A meta-analysis was conducted to provide refined estimates of local recurrence risk, combining data from the 2 validation studies and integrating the effect of patient age and tumor size.

This analysis showed7:

  • DCIS Score result and clinicopathologic features (tumor size, age at diagnosis, and year of diagnosis) contribute to the prognostic value of the 10-year risk of local recurrence estimate
  • The DCIS Score result contributes significantly to the prognostic value of the 10-year risk of invasive local recurrence
  • Improved assessment of local recurrence risk with combined DCIS Score-tumor size-age vs either DCIS Score result alone or tumor size-age
    • Using DCIS Score result with tumor size and age, more women at higher risk of local recurrence are identified
    • Using DCIS Score result with tumor size and age, more women at lower risk of local recurrence are identified

     

Support your decision-making process with the Breast DCIS Score Test

Identifies more patients with very low risk of local recurrence7*

DCIS Score result with tumor size and age
25.9%
17.7%
0%
DCIS Score result only
Tumor size and age only
Percentage of Patients with Risk ≤ 8%

 

Identifies more patients at higher risk of local recurrence7*

DCIS Score result with tumor size and age
21.1%
18.4%
10.9%
DCIS Score result only
Tumor size and age only
Percentage of Patients with Risk > 15%

*Meta-analysis prediction for 10-year local recurrence risk, adjusted for diagnosis year of 2000 or later.

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