Thank you for your interest in the DecisionDx-UM test.

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Welcome to Castle Biosciences, Inc.

If you or someone for whom you care has been diagnosed with uveal melanoma, what you need most as you face the challenge is information. The more information you have, the more educated your decisions can be. It is with this important fact in mind that you have come to explore DecisionDx-UM. We at Castle believe the best way to approach a treatment plan begins with information gathering, followed by collaborative decision-making. DecisionDx-UM is an important component of a comprehensive baseline evaluation. By arming yourself, family and physician with as much information as possible, you arm yourself with the power of choices.

INFORMATION

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COLLABORATION

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DECISION-MAKING

Uveal melanoma (UM) is a tumor originating in the eye. Studies have shown that there are two distinct groups of patients with UM. One group has a tumor that rarely spreads outside the eye. The other group has a tumor that frequently spreads outside the eye…. most often to the liver. Until now, clinical and other tests have not been overly sensitive in being able to tell which type of tumor an individual patient has. DecisionDx-UM is a new test that provides more accurate information to a physician at the time of treatment for the primary (eye) tumor.

How does it work?

DecisionDx-UM is a test that evaluates genes that are expressed in a patient’s eye tumor. These genes have been determined to be highly associated with risk of metastasis (spreading) in uveal melanoma. The test results categorize a tumor as Class 1 (low risk of metastasis) or Class 2 (high risk of metastasis). For patients with a Class 2 tumor type, it is likely that metastasis has already occurred at the time the eye tumor is diagnosed, but is clinically undetectable with today’s diagnostic tools (imaging and blood tests). With this information in hand, important decisions can be made early in treatment planning.

What does it mean?

When diagnosed with a Class 1 tumor type, a patient and their physician can be comfortable that routine follow-up (clinical visits, perhaps blood work, perhaps periodic imaging) may be sufficient after treatment of the primary (eye) tumor. However, when diagnosed with a Class 2 tumor type, a more aggressive post-operative regimen of increased surveillance imaging, clinical visits and blood work might be indicated. There are clinical trials underway for adjuvant therapies aimed at targeting suspected “micro-metastasis” (clinically undetectable, but suspected). These are important considerations that can be undertaken early on when the molecular class of a tumor is known.

What happens when the test is ordered?

DecisionDx-UM uses tumor tissue obtained from a procedure called a fine needle aspirate biopsy (FNAB). The test can also use tumor tissue obtained from a preserved globe if you elect to have an enucleation procedure (removal of your eye). Information about the risks and benefits of FNAB and enucleation will be discussed separately by your physician/staff. Most often, the sample will be frozen immediately following collection and shipped to Castle for testing shortly thereafter.

How is DecisionDx-UM paid for?

Castle Biosciences, Inc. will be working with Medicare, commercial insurance providers and, in some cases, your physician's institution to secure payment coverage for DecisionDx-UM. Claims will be submitted on patient's behalf and followed through the system to payment. In instances where the test is not covered by insurance, or only partially covered, the balance of the payment will become the patient's responsibility. The Castle Patient Assistance Program is in place to help manage balances due and to provide assistance in cases of financial hardship.