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Frequently Asked Questions
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.
The goal of the TissueCypher test is to predict your personalized risk of progressing to high-grade dysplasia or esophageal cancer. Knowing this potential risk helps your physician gauge how aggressively to treat your Barrett’s esophagus. Your TissueCypher test result includes a risk score and a five-year probability of progression to high-grade dysplasia or esophageal cancer. For example, a risk score of 8.0 has an associated five-year probability of progression of 27%. This means that during the clinical validation studies, 27% of patients with a risk score of 8.0 progressed to high-grade dysplasia or esophageal cancer within five years. Knowing your personalized risk enables your physician to make risk-aligned adjustments to your care plan.
TissueCypher has been in clinical use since 2016 and has been validated in five clinical validation studies using one of the largest sets of BE progressors ever assembled.
The majority of people tested with TissueCypher receive a low-risk score, which is expected because most Barrett’s esophagus patients don’t progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). A high-risk score gives your healthcare provider an opportunity to align your treatment to your predicted risk of progression, to escalate care and intervene early.
TissueCypher provides a risk score and probability of development of high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) within five years. In a recent study by the Mayo Clinic, TissueCypher was shown to independently predict increased risk of progression to HGD/EAC and was also shown to be a stronger predictor of progression than other traditional risk factors like age, sex, segment length, and even expert pathology. Multiple published studies have shown that TissueCypher has a higher positive predictive value than these traditional risk factors, e.g., patients who receive a TissueCypher high-risk score progress at a higher rate than patients with confirmed low-grade dysplasia.
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