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Frequently Asked Questions
Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for the DecisionDx-UM test. Castle will submit insurance claims and manage the insurance billing process on behalf of patients. The company also sponsors an industry-leading Patient Assistance program with the belief that quality care should not depend on financial considerations. For more information about insurance coverage, claims processing and financial assistance call 866-788-9007 and select option #3.
Castle began storing residual tissue after DecisionDx-UM testing in mid-2015. If your biopsy was collected after that time, Castle may have residual tumor tissue remaining following your DecisionDx-UM test. If enough residual tissue is remaining, your provider may request that these additional tests be performed on your sample.
Castle’s Clinical Services Team can tell you whether there is residual sample remaining after testing is complete. For inquiries regarding residual sample, call 866-788-9007 and select option #1.
The DecisionDx-UM test is the most accurate prognostic test for uveal melanoma available. Data from an independent, prospective study of 494 patients conducted by the Collaborative Ocular Oncology Group (COOG) showed that the GEP test (DecisionDx-UM) could successfully classify tumors more than 97 percent of the time. There are now more than 20 published studies supporting use of the DecisionDx-UM test.
DecisionDx-UM results provide critical prognostic information for you and your doctor to determine the most appropriate plan for monitoring for metastatic disease and potential treatment. While the test cannot, at this point, guide your doctor toward a specific treatment, recent studies show that the results are being used to develop personalized monitoring plans based on a patient’s metastatic risk, initiate referral to a medical oncologist for treatment planning, and refer appropriate high-risk patients to clinical trials.
The DecisionDx-UM test can only be ordered by your physician or other appropriate healthcare provider—usually an ocular oncologist, retinal specialist, or ophthalmologist. Currently, a majority of ocular oncology specialists in the country offer DecisionDx-UM to their patients. If your doctor does not perform the test and you would like further information, you can call Castle Biosciences customer service at 866-788-9007 option #1.
The DecisionDx-UM test requires a tiny sample of your tumor, commonly taken with a very thin needle (called a fine needle aspirate biopsy or FNAB). If you are having radiation treatment, your doctor must take the sample before surgery. Thousands of biopsy procedures have been performed safely in uveal melanoma, and the literature suggests that complications are rare. However, as with any surgical intervention, the potential risks should be fully discussed and considered with your doctor.
If you choose to have the test, timing is critical. For patients undergoing radiation treatment, a small sample of the tumor tissue must be taken before surgery as radiation may alter the genes in your tumor and skew the lab results. If the treatment plan is enucleation, the tumor sample can be provided either from a biopsy taken at the time of enucleation, or by obtaining tissue slides from the wax block (FFPE) made following surgery and maintained in the pathology lab.
The DecisionDx-UM test can tell you whether your eye tumor falls into one of three classes, identifying the statistical risk of metastasis over the next five years, the period for which scientific data has been collected. These include:
- Class 1A: Low risk, with a 2% chance of metastasis over five years
- Class 1B: Intermediate risk, with a 21% chance of metastasis over five years
- Class 2: High risk, with a 72% chance of metastasis over five years
The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of a patient’s primary tumor to determine the risk that the tumor will spread (metastasize) from the eye to other parts of the body. The test is validated for expression profile (GEP), or molecular signature, of a patient’s primary tumor to determine the risk that the tumor will spread (metastasize) from the eye to other parts of the body. The test is validated for use on both fine needle aspirate biopsy (FNAB) tissue and formalin-fixed, paraffin-embedded (FFPE) tissue. Test results are typically reported within two weeks of receiving the biopsy sample from the treating physician.