Additional UM Tests

DecisionDx®-PRAME

DecisionDx®-PRAME testing for additional prognostic information

PRAME, or preferentially expressed antigen in melanoma, is a gene that has been the focus of two recent studies in uveal melanoma that were published in Clinical Cancer Research (Field et al. 2016) and Oncotarget (Field et al. 2016). PRAME is usually not expressed in normal adult tissues, but in some cancers, PRAME expression is elevated. Studies have suggested that elevated PRAME expression (“PRAME-positive”) in a Class 1 uveal melanoma tumor may be associated with an increased risk of metastasis compared to a Class 1 tumor that does not express PRAME (“PRAME-negative”). Class 2 tumors already have a higher risk of metastasis, and in these tumors, PRAME positivity may be associated with a shorter time to metastasis than PRAME-negative Class 2 tumors.

PRAME is a major focus of ongoing uveal melanoma clinical research, including an ongoing prospective, multi-center study. Additionally, therapies targeting PRAME are in clinical trials for other types of cancers and may be relevant to uveal melanoma in the future. Because most patients receive radiation as their primary eye treatment, there is usually no leftover tissue for future testing except for the biopsy tissue used for gene expression profiling. Due to the precious nature of each biopsy, Castle Biosciences provides PRAME testing at the request of physicians who order DecisionDx-UM. If you are having DecisionDx-UM testing performed on your tumor and are interested in knowing your PRAME status, please discuss this additional test with your physician.

The exact impact of PRAME status on your risk for metastasis has not yet been determined and is under further investigation. DecisionDx-PRAME results are reported only at the request of the ordering physician.
If you have questions about the DecisionDx-PRAME test, please contact us at 866-788-9007 or by email.

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DecisionDx®-UMSeq

Gene sequencing panel: DecisionDx®-UMSeq

Researchers believe that identifying mutations in tumor genes may someday help guide treatment decisions. Because the amount of tumor biopsy tissue is limited, it is important to gain as much information as possible about a uveal melanoma tumor from a single biopsy. To provide additional genetic information from your biopsy, Castle Biosciences offers an optional gene sequencing panel that can find mutations in seven important genes in your uveal melanoma tumor. The gene sequencing panel DecisionDx-UMSeq is an additional test that can be run on the same sample as your DecisionDx®-UM GEP and DecisionDx-PRAME test.

The results of the DecisionDx-UMSeq panel, along with those from the DecisionDx-UM and DecisionDx-PRAME tests, will provide your physician with a comprehensive genomic profile of your UM tumor from a single biopsy. This genomic information can be used to help guide your care and may also become useful in the future as UM scientific research and therapeutics evolve. In the majority of cases, your ophthalmologist will only collect a single biopsy sample. We offer DecisionDx-PRAME and DecisionDx-UMSeq because your biopsy sample is precious and we believe that providing as much genomic information as possible is the right and ethical decision.

It is important to remember that information from the gene sequencing panel is NOT a substitute for the DecisionDx-UM GEP test. The DecisionDx-UM GEP test is the only uveal melanoma prognostic method that has been prospectively validated in multiple studies, providing the most robust prognostic information.

DecisionDx-UMSeq can be ordered for any patient who is having DecisionDx-UM GEP testing. No additional biopsy is required. The DecisionDx-UMSeq gene sequencing panel will be submitted to your insurance company for payment.

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