Precise.
Personalized.
Proven.

The DecisionDx-Melanoma gene expression profiling (GEP) test empowers you to make more informed decisions and ultimately improve patient care. 

The only GEP test associated with improved patient survival1

DecisionDx-Melanoma provides personalized results for patients with stage I-III cutaneous melanoma, guiding risk-aligned management decisions. By combining tumor biology with traditional clinicopathological features, the test offers two critical applications for dermatologists:

  1. What is the likelihood of sentinel lymph node positivity?

  2. What is my patient's risk of recurrence or metastasis?

The limitations of staging

While over 90% of melanoma patients are initially diagnosed with stage I or II disease and are frequently assumed to be low risk, this same group accounts for 62% of melanoma-related deaths.*2-6

What does this mean?

  • AJCC staging alone is inadequate for predicting clinical outcome
  • Many high-risk tumors are being misidentified as low risk at the time of diagnosis
  • There is opportunity to increase prognostic accuracy 

*excluding stage IV

DecisionDx-Melanoma guides risk-aligned patient management and can improve outcomes

   

Recent data from an ongoing collaboration with the National Cancer Institute’s (NCI) Surveillance, Epidemiology and End Results (SEER) program registries show that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. In the study, DecisionDx-Melanoma provided significant and independent risk stratification of patients with cutaneous melanoma, beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage, which may help inform more personalized patient management decisions.1

 

 

  • DecisionDx-Melanoma provides a comprehensive,
    personalized result

       

    A: Class result and GEP score

    Classification of GEP as a Class Result & GEP Score for risk of recurrence and/or metastasis within five years. Results are reported as:

       

    • Class 1A - Lowest Risk (0 to 0.41)
    • Class 1B/2A - Increased Risk (>0.41 to <0.59)
    • Class 2B - Highest Risk (0.59 to 1.0)

        

       

    B: Personalized risk of recurrence estimates

    The validated i31-ROR algorithm integrates the 31-GEP score with the patient's specific clinicopathologic factors of Breslow thickness, ulceration, mitotic rate, SLN status, age and binned tumor location. Personalized 5-year outcomes for three distinct endpoints are reported:

       

    • Melanoma-Specific Survival (MSS)
    • Distant-Metastasis Free Survival (DMFS)
    • Recurrence-Free Survival (RFS)

       

       

    C: Personalized likelihood of sentinel lymph node positivity

    The validated i31-SLNB algorithm integrates the 31-GEP score with the patient's specific clinicopathological factors of Breslow thickness, ulceration, mitotic rate, and age. It provides a personalized risk assessment for the likelihood of having a positive sentinel lymph node biopsy (SLNB).

    This information will not be reported if a SLNB has already been performed. 

Hear from an expert

Shannon Trotter, DO, FAOCD, FAAD, discusses how she uses DecisionDx-Melanoma to personalize care

A real-world case study: How DecisionDx-Melanoma changed management of a stage 1 (T1a) tumor

34-year-old female presented with lesion on the arm

Patient demographics

  • 34-year-old, Female
  • Invasive malignant melanoma
  • 0.6 mm Breslow Depth
  • No Ulceration
  • No evidence of mitoses
  • No TILs present
  • No satellitosis
  • Clark Level III

Management plan

(Based on AJCC Staging & NCCN Guidelines)

H&P every 6-12 months for five years, then annually.

Rationale for ordering DecisionDx-Melanoma

Because of the patient’s age and Breslow depth being on the thicker end of a thin melanoma, the clinician wanted additional guidance on the management plan for this patient.

Test result & impact to patient care

   
DecisionDx-Melanoma Result: CLASS 2B Highest Risk

  • Referred to medical oncologist for high-intensity surveillance (CT scans every six months).

Outcome

  • During the patients 6-month scan, a met to the lung was identified. Biopsy showed it was a proven oligment that was BRAF negative.
  • Patient was treated with radiotherapy to the lung and started on combination therapy.
  • Patient is doing well with clear scans at more than six years.

Ready to enhance your decision making and improve patient outcomes?

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References

  1. Bailey et al. JCO PO. 2023
  2. AJCCv8  CA Cancer J Clin. 2017.
  3. SEER program database (released July 2022)
  4. Whiteman D et al. J Invest Derm. 2015
  5. Shaikh W et al. J Natl Cancer Inst. 2016
  6. Ibrahim et al. Ann Surg Oncol. 2020