Precision diagnostics for personalized melanoma care

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1 Precision diagnostics for personalized melanoma care The MelaGenix Gene Expression Test Helping your doctor find the right melanoma treatment for you Learning that the tiny mole on your body is actually a deadly skin cancer called melanoma must have been a huge shock. Luckily, when melanoma is detected early, the chance of cure is fairly high. After the initial excision of the tumor and its margins, your doctor may recommend further treatments such as lymph node removal and/or adjuvant tumor medication depending on the local progression of the melanoma as well as your state of health. These procedures are usually done to prevent the cancer from spreading or coming back. However, it is not easy to obtain the optimal postsurgery melanoma treatment. Melanoma therapies have their downside. Lymph node surgery can leave disfiguring scars and lifelong swelling of the arms and legs (lymphedema). Adjuvant therapies, on the other hand, have life-threatening side effects. To determine the best treatment strategy, your doctor needs to know to what extent the cancer will progress given your body s protective capacity and its individual ability to fight melanoma. Recommended for patients diagnosed with early to intermediate stage melanoma, MelaGenix is a multigene expression test that accurately predicts your chances of combating your individual skin cancer based on your unique genetic profile. The MelaGenix Test analyzes the activities of 8 genes from your tumor tissue, which reflect your tumor biology and your body s capability to fight cancer. The resulting individual MelaGenix Risk Score predicts your chances of cancer-free survival without adjuvant treatment for the first 10 years from diagnosis. With the help of MelaGenix, your doctor can make more accurate decisions on your therapy, and plan the best way of managing your melanoma. As a result, more informed decisions regarding treatment can increase your chances of recovery and cure. Ask your doctor about MelaGenix today.

2 The MelaGenix 8-Gene Signature Assessing your personal risk through tumor genetics Designed for patients diagnosed with stage I, II or III cutaneous malignant melanoma, MelaGenix determines the biological activity of 8 genes within the primary melanoma and surrounding skin tissue through a highly-sensitive quantitative polymerase chain reaction (qrt-pcr) technology. The test is performed on the tumor sample up to three times under very strict laboratory conditions to rule out even the smallest of analytical errors. Data on the tumor biology are then used to calculate your individual MelaGenix Risk Score by means of a proprietary mathematical algorithm. Your Risk Score ascertains your individual relapse risk (probability of the cancer coming back) as well as your unique metastasis risk (the chances of the cancer spreading to other parts of your body). With this information at hand, you and your doctor can decide on the melanoma treatment and followup cancer care that suits you best. For more information on MelaGenix, visit

3 The MelaGenix Risk Score Complementing conventional cancer staging with genetic risk assessment Despite the availability of genetic testing, melanoma treatment is still widely based on the clinical progression of the cancer or its stage as prescribed by the American Joint Committee on Cancer (AJCC). Conventional AJCC staging is based on the thickness of the tumor, the extent of metastases in the lymph nodes and in distant parts of the body, labelling it as stage 0 to IV, as well as the occurrence of ulcerations and high mitoses rate, which further classifies the stages I-III into A, B or C. Those with tumors in the early stages of progression (stage 0 or I) are usually not given adjuvant treatment, and those with tumors in the later stages (stage II or III) are typically given both surgical lymph node resection and adjuvant therapy, such as immune- or radiation therapy. Unfortunately, conventional staging alone has been found to be an unreliable predictor of relapse and metastatic risk among melanoma patients. A study by the Hornheide-Muenster Skin Cancer Center in Germany found that conventional staging misclassified 40.8% of patients across melanoma stages I, II and III. Eighty-six (86) of the 211 patients in the study were incorrectly diagnosed: Among those were early-stage melanoma patients, which suffered from melanoma relapse within 5 years, but were classified by conventional staging as lowrisk. Furthermore, later-stage patients were misclassified by conventional staging as high-risk, which exposed them to the hazards of adjuvant therapy, although their genetic risk of relapse and metastasis was very low. These findings supported the need for personalized melanoma risk assessment independent of conventional cancer staging and paved the way for the MelaGenix gene expression test. Extracted from one of the largest annotated tumor tissue banks worldwide, the MelaGenix Test uses a group of eight prognostic genes in melanoma and its surrounding healthy tissue, all of which are linked to the progression of the disease. After investigating hundreds of melanoma samples, the scientists developed a formula based on this eight-gene signature to calculate a patient s individual risk of relapse and metastasis. The result of the risk assessment is the MelaGenix Risk Score. The Risk Score complements classical tissue diagnostics and determines the patient s treatment requirements with precision. The MelaGenix Risk Score was validated on the basis of tumor tissue from as yet over 400 melanoma patients to assess its accuracy. Through analysis of the primary tumor tissue, the MelaGenix Risk Score accurately predicts how an individual patient s skin melanoma will progress. It calculates the probability of the cancer spreading to other parts of the body and the likelihood of the cancer coming back within 10 years independent of AJCC staging. Ask your doctor about how MelaGenix can specify your melanoma prognosis.

4 Your individual MelaGenix Risk Score Understanding your individual risk to personalize your melanoma treatment MelaGenix accurately predicts your chances of combating your individual form of skin cancer based on your unique genetic profile. The test procedure does not involve surgery and, therefore, is fully risk free. Since MelaGenix uses tumor tissue that is routinely preserved and stored for further diagnostics after your surgery, all you need to do is asking your physician to order the test. NeraCare will then request the archived tissue sample from the relevant pathology laboratory. After receiving your MelaGenix Test result, your doctor will inform you on your new risk-based classification using MelaGenix alongside conventional AJCC staging. Rather than categorizing your melanoma according to skin cancer progression, MelaGenix determines your precise relapse and metastatic risk as an individual. This gives your doctor a sounder basis for selecting the treatment that is right for you. Ask your doctor about how MelaGenix can help plan your personalized melanoma treatment.

5 If your melanoma is at an early stage (stage I)... a low MelaGenix Risk Score confirms that your melanoma was caught early enough and you have a very good survival probability in the next 10 years. As set by standard care, adjuvant therapy is not necessary and you could rest assured that a relapse or metastasis is highly unlikely. a high MelaGenix Risk Score indicates that you have an increased relapse risk of up to 50% within the next 10 years. Although your melanoma has been found to be in an early stage, intensified follow-up care, adjuvant treatment and post-surgery care are worth considering as they can help prevent cancer recurrence and increase your chances of being cured. If your melanoma is at an intermediate stage (stage II)... a low MelaGenix Risk Score means that you have a low probability of relapse and an excellent survival probability of over 90% for the next five years even without treatment. In this case, you and your doctor might rethink your treatment options, since standard adjuvant therapy could expose you unnecessarily to hazardous side effects. a high MelaGenix Risk Score indicates that you have an increased relapse risk of up to 80% within the next 10 years. You and your physician should definitely discuss adjuvant treatment options as well as more aggressive and targeted melanoma management to prevent cancer recurrence and to increase your chances of a cure. If your melanoma is at an advanced stage (stage III)... a low MelaGenix Risk Score means that you have a low probability of relapse and a fairly high probability of overall survival. Less aggressive therapy options may be worth considering, as they keep you from being exposed to hazardous, lifethreatening side effects. a high MelaGenix Risk Score confirms that the probability of the cancer coming back within the next 5 years is very high at about 76%. Therefore, it is imperative that you consider intensified follow-up care and additional targeted treatment forms. It may be worth exploring treatment options outside the standard care such as new drug therapies in clinical trials.

6 Ordering the MelaGenix Test The MelaGenix Test uses tumor tissue from your initial melanoma excision. This tumor tissue is routinely preserved and stored for further diagnostics. This is why you can order the MelaGenix Test without the need for further surgery. Like other laboratory tests, the MelaGenix Test can only be requested by a physician, such as your dermatologist or oncologist. Should you wish to have the MelaGenix Test performed, please ask your consulting physician to fill out and sign the MelaGenix Test request form. Please find our test request form at request. For help with the ordering progress, please contact us at info@neracare.com. MelaGenix is developed and distributed by NeraCare GmbH, the company founded by the inventors of the 8-gene expression test with headquarters at the Bio- Security Center in Boenen, Germany. As soon as we receive your physician s complete order form, we will arrange the collection of your primary melanoma sample from your pathology laboratory. Upon sample arrival at our molecular biology laboratory, we will perform the MelaGenix Test under certified and accredited conditions and determine your personal MelaGenix Risk Score. NeraCare shall deliver test results directly to your consulting physician within 2 to 3 weeks following receipt of your tissue sample. Cost Reimbursement The MelaGenix gene expression test has been available since 2015 and some private insurances in Germany already reimburse the costs of the test on a case-to-case basis. Patients would have to initially shoulder the full cost of the gene test. A 50% down payment is required through money transfer or credit card upon placement of the order. The remaining 50% is due upon delivery of the MelaGenix Risk Score to your consulting physician. Depending on your country, some private health insurances and medical aid authorities may be willing to cover the costs of the gene test. Please contact your insurance provider for information on reimbursement options. Should you need assistance in reimbursement claims, please do not hesitate to contact us at info@neracare.com. The complete terms and conditions for the MelaGenix Test are available at