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Frequently Asked Questions
The DecisionDx-SCC genomic test measures the biological activity of specific genes in your tumor that tell how likely it is for your tumor to spread or metastasize. The DecisionDx-SCC test identifies the risk of squamous cell tumors spreading better than traditional measures alone. It is intended to be used in patients with an SCC diagnosis and the presence of one or more traditional risk factors.
Your healthcare provider can use your test results, in combination with other information and procedures, to personalize your treatment and follow-up care. For example, if your tumor is low (Class 1), routine treatment options may be a reasonable choice, avoiding unnecessary treatments and frequent follow-up unless they become necessary later. Conversely, if your test results identify your tumor as moderate or high biological risk (Class 2A or 2B) perhaps a more aggressive approach to treatment.
If you wish to have the DecisionDx-SCC test, please discuss it with your healthcare provider. Only a healthcare provider (physician, physician assistants, or nurse practitioner) can order this test.
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.
DecisionDx-UM is Castle’s 15-gene expression profile (GEP) test that uses tumor biology to predict a patient’s individual risk of cancer metastasizing (spreading to other parts of the body). DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since its availability in 2009, over 15,000 patients have been clinically tested with DecisionDx-UM.
Castle offers three tests for patients with uveal melanoma that can all be run from a single tumor biopsy sample: DecisionDx-UM (standard of care-adopted by ~90% of ocular oncology centers); DecisionDx-PRAME (optional supplemental test); DecisionDx-UMSeq (optional supplemental test). The DecisionDx-UM test is the most extensively validated prognostic method for uveal melanoma and is considered standard of care due to its wide acceptance by physicians and its inclusion in national guidelines.
Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for the DecisionDx-SCC 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.