MelaGenix – the new multigene expression test

The prognostic eight-gene signature of MelaGenix is the result of 20 years of scientific research. The activity pattern of these genes provides the resultant MelaGenix risk score (MG score) that supplements your current prognostic assessment and can fundamentally change treatment decisions , based on significant changes in the overall survival probability (Fig. 1). The MelaGenix multigene expression test was developed to determine the risk of relapse of patients who are diagnosed with melanoma in the early and intermediate stages (AJCC stages I and II) and for the treatment optimization for patients who already display regional metastasis at the time of diagnosis (AJCC stage III).
The MelaGenix score determines the individual risk of relapse. It can result in an entirely new assessment of melanoma outcome for many patients and, thus, can significantly change treatment decisions in melanoma care

MelaGenix – Personalized melanoma treatment through more precise prognosis of risk

Medical treatment of malignant melanoma, especially its diagnosis and treatment, is swiftly developing toward a personalized approach. The progression of the disease is very individual following the initial diagnosis and offers the prospect of full recovery, yet only if the available information is fully utilized. The gene-expression based prognosis of melanoma now opens up a new dimension of identifying the risk of relapse with increased precision. The MelaGenix multigene expression test determines individual tumor gene activity by quantitative RT-PCR in the primary melanoma.

Figure 1. Overall survival rate of melanoma patients as a function of the MelaGenix score. Kaplan-Meier analysis is based on a cohort of 125 FFPE primary melanomas.

Stage I / II / III

Melanoma patients at an early stage (stage I):

The risk of relapse for patients in the early developmental stage (stage I) is classified as low according to conventional AJCC criteria (Fig. 2; black line). If an MG score ≥ 1.3 is determined here, the melanoma-specific mortality risk for this low-risk patient group can increase to up to 50% (Fig. 2; red line; mortality risk comparable to AJCC stage III). Based on this risk estimate, intensification of treatment and follow-up care might be considered, since, to this day, about 5% of stage IA and 14% of stage IB patients suffer a relapse and die as a consequence of their melanoma. Currently, this patient group comprises the greatest proportion of all deaths caused by melanoma. Not all, but about 40% of patients with thin high-risk (fatal) melanomas are identified by MelaGenix and, thereby, could be helped in the future reduction of undersupply of treatment.

Figure 2. Overall survival rate of AJCC stage I melanoma patients (black) as a function of the MelaGenix score (green: MG score < 1.3; red: MG score ≥ 1.3) compared to conventional AJCC stage classification. Kaplan-Meier analysis is based on a cohort of 94 FFPE primary melanomas.

Melanoma patients at an intermediate stage (stage II):

In stage II, the individual assessment of the risk of relapse supports treatment decisions. The guidelines prescribe adjuvant interferon alpha therapy for this patient group. However, this treatment can cause significant side effects in some cases. The risk of relapse decreases to about 20%, if a low MG score is determined for stage II, implying that patients with a low risk score have an excellent survival probability, even without adjuvant therapy. About 75% of these low-risk stage II patients are currently identified by the MelaGenix test. This is a patient group of significant size who could decide whether or not to have adjuvant therapy on the basis of their personal risk (reduction of oversupply of treatment).

Figure 3. Overall survival rate of AJCC stage II melanoma patients (black) as a function of the MelaGenix score (green: MG score < 1.3; red: MG score ≥ 1.3) compared to conventional AJCC stage classification. Kaplan-Meier analysis is based on a cohort of 42 FFPE primary melanomas.

Patients with regional metastasis (stage III):

In stage III, the MelaGenix score provides additional security whether this is a case of a high risk melanoma that urgently requires further treatment. This also enables the selection of patients with a particularly high risk of relapse for participation in clinical studies and the future use of targeted therapies.
More security in prognostic assessment, particularly of melanomas that are difficult to prognosticate, and in decisions regarding follow-up care. As very profound treatment decisions have to be made immediately upon confirmation of the diagnosis, the precise determination of a patient’s risk of relapse can be useful. For instance, MelaGenix helped to correct more than 1/3 of prognoses for melanoma cases from all relevant AJCC stages IA to IIIC that represented a 41% rate of AJCC-based incorrect prognoses.
Patients with a high risk score (depending on their AJCC stage) should be monitored more closely or treatment intensification should be considered. Patients who know their risk of relapse are able to personally weigh the side effects of an adjuvant therapy and can choose an individually tailored treatment option together with the physician.

Figure 4. Overall survival rate of AJCC stage III melanoma patients (black) as a function of the MelaGenix score (green: MG score < 1.3; red: MG score ≥ 1.3) compared to conventional AJCC stage classification. Kaplan-Meier analysis is based on a cohort of 106 FFPE primary melanomas.

Logistics und technical determination (2-3 weeks)

Reimbursement

The private health insurances usually bear the costs for the MelaGenix multigene expression test. An application for reimbursement of costs may be necessary in individual cases. The statutory health insurances not yet under obligation to cover the test costs. However, we are happy to assist you.