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 Utility

The Oncotype DX Colon Recurrence Score® test was developed and refined in several collaborative studies that included both anatomic stage II and stage III colon cancer patients. Using the trusted Oncotype DX® platform, scientists identified the genes that provide real insights into colon cancer tumor biology, which impact risk of recurrence.1-3

Confidently plan a course of treatment based on clinically validated results.

The Colon Recurrence Score® test uses Exact Sciences’ well-established RT-PCR (reverse transcriptase-polymerase chain reaction) platform to offer individualized, quantifiable risk of recurrence for patients with colon cancer (anatomic stages II, MMR-P, or III A/B).4-7 With this information, you and your patient can more confidently plan a course of treatment based on clinically validated results.

Bolstering treatment recommendations in the SUNRISE-DI study8

Impact of the 12-gene recurrence score test on deciding adjuvant chemotherapy for stage II and IIIA/B colon cancer: the SUNRISE-DI study

  • This study investigated the impact of the Oncotype DX Colon Recurrence Score test on adjuvant chemotherapy decision-making
  • Physicians changed treatment recommendations in 45% in stage IIIA/B and 30% in stage II patients after receiving Colon Recurrence Score test results
  • Physician confidence in their treatment recommendations significantly increased from 54% to 81% in stage IIIA/B and from 65% to 83% in stage II after receiving Colon Recurrence Score test results

View study details

Clinically validated in 4 studies with approximately 3000 patients

Stage II Colon Cancer Stage III Colon Cancer
SUNRISE Trial
Confirmed the prognostic capabilities of the test, beyond clinical and pathologic factors, in both stage II and stage III colon cancer7

View study details
NSABP C-07 Trial
Further confirmed the use of the test to stratify patients in stage II and validated the test as prognostic of risk of recurrence in stage III colon cancer6

View study details
CALGB 9581
Confirmed the ability to stratify patients by risk5

View study details
QUASAR Study
Found that the test is strongly associated with the risk of recurrence and provides information beyond clinical and pathological factors4

View study details

SUNRISE trial findings

The SUNRISE retrospective cohort study included archived tissue from 597 stage II and stage III Japanese patients treated with surgery alone. The SUNRISE study7:

  • Confirmed the prognostic capabilities of the Colon Recurrence Score test in stage II colon cancer
  • Was the first clinical validation of the test as a prognostic marker of recurrence risk in patients with stage III colon cancer treated without adjuvant chemotherapy
  • Provided new insight into the natural history of stage III colon cancer treated without chemotherapy and showed the heterogeneity in risk of recurrence

Recurrence Risk Estimated by Oncotype DX Risk Group and Disease Stage

Stage II Disease
RISK GROUP % OF PATIENTS 5-YEAR RECURRENCE % (95% CI)
All 100 11 (9 to 14)
Low 60 8 (6 to 11)
Intermediate 26 13 (8 to 19)
High 14 24 (17 to 34)
Stage III A/B Disease
RISK GROUP % OF PATIENTS 5-YEAR RECURRENCE % (95% CI)
All 100 27 (22 to 32)
Low 46 22 (16 to 30)
Intermediate 31 25 (17 to 35)
High 23 39 (28 to 51)

CALGB 9581 study findings

Consistent with QUASAR, in the CALGB 9581 study, the Recurrence Score® result was shown to be prognostic for recurrence risk, supporting the results of the first validation study. This study featured 690 stage II colon cancer patients perceived to be low risk (based on the clinical and pathologic characteristics), with an average 5-year risk of recurrence of 13%.5

  • Is a significant predictor of risk of recurrence (P=0.004) in multivariable analysis, providing independent value beyond conventional clinical and pathologic factors
  • Identified 22% of the patients in the high Recurrence Score test group, with an average 5-year recurrence risk of 21%
    • Therefore, the test can discriminate a higher-risk patient population beyond conventional measures—even in a cohort of perceived low-risk patients

NSABP C-07 study findings

This independent, prospectively designed, validation study of the Colon Recurrence Score test included 892 stage II and stage III patients randomized to 5-FU/LV or 5-FU/LV plus oxaliplatin. The NSABP C-07 trial6:

  • Validated the test as prognostic of recurrence risk in patients with stage III colon cancer
  • Confirmed the ability of the Recurrence Score result to quantify the risk of recurrence in stage II and III patients treated with either 5-FU/LV or 5-FU/LV + oxaliplatin
  • Predicted risk of recurrence beyond conventional measures, including T and N stage, and MMR status

QUASAR Study Findings

The first validation study, QUASAR, was prospectively designed and included archived tissue from 1,436 stage II colon cancer patients randomized to surgery or surgery + 5-FU/LV. The landmark QUASAR study showed4,9:

  • A significant association between the continuous Recurrence Score result and the risk of recurrence (P=0.004)
  • In the multivariate analysis of patients randomized to surgery alone, the most significant independent predictors of risk of recurrence were:
    • Recurrence Score result
    • Mismatch Repair (MMR) status
    • T-stage
  • T3, MMR-P patients with Recurrence Score result ≥41 have similar risk to T4, MMR-P patients and may have a higher absolute benefit from adjuvant chemotherapy
In Stage II patients following surgery, a Recurrence Score result predicts individual recurrence risk4
Validated as an independent, quantitative assessment of recurrence risk in Stage II colon cancer—QUASAR Study9
  • Patients with a Recurrence Score result ≥41 had recurrence risk >18%, similar to some T4, MMR-P patients
  • Therefore, these patients are expected to have higher absolute benefit from 5-FU/LV compared to those with low Recurrence Score results