Thank you for your interest in the DecisionDx-UM test.

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Uveal Melanoma (UM)...

Uveal melanoma (UM) is the most common form of eye cancer, the second most common site of melanoma, and frequently leads to metastatic disease. Uveal melanomas can arise in the iris, ciliary body and choroid (all parts of the uveal tract).

Treatment Goals and Treatments...

The primary goals of ocular treatment of uveal melanoma are to reduce the risk of metastasis, prevent local growth and destruction of ocular tissues and preserve as much vision as possible.

Until recently, enucleation (removal of the eye) was the most common treatment of the primary tumor. However, the Collaborative Ocular Melanoma Study (COMS) comparing plaque radiotherapy to enucleation for medium-sized posterior uveal melanomas found no difference in survival between the two therapeutic options. Knowing this, many ophthalmologists choose to employ globe-sparing treatment plans.

As a result of the COMS data, the most common treatment of the primary tumor is plaque brachytherapy. Brachytherapy involves the temporary placement of a radioactive plaque on the eye overlaying the area of the tumor. The plaque is left in place for several days to deliver a localized dose of radiation to the tumor.

Treatments of enucleation, brachytherapy, and proton beam irradiation are all highly effective at controlling the primary eye tumor.

However, by the time of primary tumor diagnosis, up to half of the patients with uveal melanoma already have microscopic or sub-clinical metastasis – predominantly to the liver. Unfortunately, these micrometastases are too small to be detected with today’s diagnostic techniques (imaging and liver function tests) until the metastatic tumor cells have multiplied many times and have become resistant to therapy.

The Need for DecisionDx-UM...

With its high metastatic rate, the ability to stratify uveal melanoma into patients with low risk versus high risk of microscopic metastasis offer the opportunity to:

• Monitor high risk tumors more aggressively than the same current level of post-treatment monitoring for uveal melanoma;
• Offer patients with high risk tumors more aggressive adjuvant treatment given the trade-off between the likelihood of metastatic disease and the risks of interventional treatments;
• Give patients the information they need to plan their lives and cope with their diagnosis.

What is DecisionDx-UM...

The DecisionDx-UM assay was developed to assist with some of these questions.

The DecisionDx-UM assay is a robust metagene expression assay that determines the molecular signature of a UM tumor. This signature enables prospective stratification of the tumor’s metastatic risk. Tumors with a Class 1 signature are associated with a good prognosis and have low metastatic potential; whereas patients with a Class 2 signature have a high metastatic potential. Based upon the completion of the validation of this gene expression assay and its clinical importance in the management of patients with uveal melanoma, the 7th Edition of the American Joint Committee on Cancer (effective January 1, 2010) has identified this assay as "key prognostic factor that (is) important to collect in [uveal melanoma]". The DecisionDx-UM gene expression assay is recommended for collection because it was determined to be "clinically significant".

The DecisionDx-UM assay can only be ordered by a physician (most commonly an ophthalmologist) and requires a sample of the tumor.

For patients undergoing brachytherapy, the sample needs to be taken before the plaque is attached. Many ophthalmologists currently take tumor samples immediately prior to brachytherapy by fine needle aspirate biopsy (FNAB) in the operating room for diagnostic purposes. The DecisionDx-UM assay requires a single biopsy specimen.

There are two specimen options if removal of the eye (enucleation) is the selected treatment. The preferred option is to perform the FNAB in the operating room immediately following removal of the globe. Alternatively, if adequate formalin fixation has been performed, then unstained slides from the formalin-fixed, paraffin embedded globe can be used.

Specific information regarding specimen collection can be found under the 'To Order DecisionDx-UM' tab above.