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  5. MELAGENIX - Molecular Diagnostic Tests ...

MELAGENIX - Molecular Diagnostic Tests for Patients

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From the moment melanoma is diagnosed, your patient depends on you to recommend the best course of action. Hovever, it is important to remember that no two melanoma patients or their tumors are alike.The MELAGENIX test provides a genomic-based, comprehensive, individualized risk assessment for stage I-III melanoma patients in the adjuvant and neoadjuvant setting.

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MELAGENIX was developed and validated to work in addition to conventional risk assessment by AJCC staging. Specifically, it provides valuable information to personalize a treatment plan for each patient’s situation.

The test uses quantitative RT-PCR to measure the expression of eleven genes (eight prognostic and three reference genes) in and around a tumor sample after it has been removed by surgery or biopsy.
After the test, the report will provide you with a risk score between -1-4 and binarize patients into one of two risk groups:
  • A low score means the cancer has a lower chance of returning
  • A high score means the cancer has a higher chance of returning
The relationship between survival and the MELAGENIX risk score demonstrates that biological risk exists on a continuum:

There are different clinical utilities for (i) patients with recently approved, highly effective therapies in the adjuvant setting and (ii) patients where these therapies are not available yet. The clinical validation efforts for MELAGENIX have been structured to take these different settings and requirements into account.

Amaral et al. (2020) clinically validated MELAGENIX in a large collective of AJCC stage II patients. This patient cohort included all patients with obtainable tumor material from the German Central Malignant Melanoma Registry archived in Tuebingen.

Of these patients, 37% were allocated to the low score group, with a median follow-up of 40 months [3 - 178] and median age of 69 [20 - 90]. 63% were allocated to the high score group, with a median follow-up of 41 months [3 - 136] and median age of 70 [26 - 93].

Univariate Cox regression analysis showed that MELAGENIX, pT, Breslow thickness (mm), age (years) were statistically significantly associated with melanoma-specific survival (MSS) while sex and ulceration were not.

Multivariate Cox regression analysis showed that MELAGENIX is an statistically significant, independent prognostic factor for MSS.

In conclusion, the MELAGENIX risk score was clinically validated as an independent prognostic factor for MSS in patients with AJCC stage II cutaneous melanoma. Specifically, the results showed that at 92%, the 10-year MSS in the MELAGENIX low risk group is equivalent to the 5-year MSS of a IIA patient.