What is the process for learning your risk?
You’ve talked with your doctor and chosen to take the DecisionDx-UM™ test, but what’s next and how does it work?
First, it’s important to know that timing is critical. For patients undergoing radiation treatment for their primary tumor, a small sample of the tumor must be taken BEFORE or at the time of surgery. This is because radiation can alter the genes in the cancer tissue used to identify your Class and thus skew the test results. In addition, the GEP test can only be appropriately used when the diagnosis of primary uveal melanoma has already been established. If it is in question, measures should be taken to confirm that the tissue being provided for analysis is uveal melanoma, as this test is for prognosis only and is unable to distinguish between uveal melanoma and other tumors of the eye. Before the procedure is performed, your doctor must order a collection kit for the tumor specimen from Castle Biosciences. Only a licensed physician or other appropriate healthcare provider can place this order (available in the Health Care Professionals section of this website).
To collect a sample of your cancer cells, your doctor will place a small needle directly into your tumor. This procedure, called a fine needle aspirate biopsy (FNAB), is common in obtaining tumor tissue in many cancers, including uveal melanoma, and literature suggests that complications are rare. However, as with any surgical procedure, you should discuss and consider the potential risks with your doctor.
Once the sample is collected, your doctor sends it out to Castle’s lab where the actual test is performed. Specifically, DecisionDx-UM measures the activity of 15 genes within the tumor to identify each patient’s individual risk of metastasis. Results are typically ready within 2-3 weeks of receiving the sample.
Timing is not an issue if the treatment plan is enucleation, or removal of the eye. In this case, the tumor sample can be taken either as a biopsy following enucleation, or by obtaining tissue slides from the wax tissue block that is made following surgery and kept in the pathology lab where the surgery took place.
Free Program to Store Tumor Tissue For Future Use
Patients also have the option of storing an additional sample of their tumor in the Castle Clinical Sample Repository. The sample can be taken at the same time as the gene test biopsy and be stored free of charge for up to five years. Availability of their tissue for analysis would allow patients to take advantage of emerging targeted treatments, clinical trials, and further prognostic testing as they become available (see Castle Clinical Sample Repository).
The last thing on your mind at this time should be how you’re going to pay for the DecisionDx-UM test. For this reason, Castle has, to date, processed all DecisionDx-UM test orders for U.S.-based physicians regardless of a patient’s ability to pay. Specifically, they work with Medicare, commercial insurance providers and, in some cases, your doctor’s institution to secure payment coverage for the test. Castle has also put a generous Patient Assistance Program in place for patients who need it.