DecisionDx-UM Overview - Castle Test Info

DecisionDx^®-UM
Overview

Enables Accurate Staging of Metastatic Risk

While uveal melanoma is the most common intraocular tumor in adults, it is a rare cancer with an annual U.S. incidence ≈ 2,000. Despite a 93% to 98% primary tumor “cure” rate, up to 50% of all patients will ultimately develop metastatic disease, primarily to the liver. However, less than 4% of patients present with metastatic disease at the time of diagnosis.

Following treatment for the primary eye tumor, the main clinical issue in uveal melanoma is determining a patient’s metastatic risk so that a risk-appropriate surveillance and management plan can be implemented.

Considered Standard of Care in Uveal Melanoma

The DecisionDx-UM gene expression profile (GEP) test enables accurate staging of 5-year metastatic risk in uveal melanoma. Since its introduction in late 2009, it has been adopted as standard of care by the majority of ocular oncology specialists in the U.S. in the management of eye cancer.

The test identifies the molecular signature of an individual’s tumor and its likelihood of metastasis within 5 years. Specifically, the assay determines the activity or “expression” of 15 genes which indicate a patient’s individual risk, or class.

Based upon the clinical outcomes from the prospective, 5-year multicenter Collaborative Ocular Oncology Group (COOG) study (Onken, 2012), the DecisionDx-UM test reports the following Class 1A, Class 1B, and Class 2 phenotypes:

Class 1A

Low risk, with a 2% risk of metastasis within 5 years.

Class 1B

Intermediate risk, with a 21% risk of metastasis within 5 years.

Class 2

High risk, with 72% risk of metastasis within 5 years.

Meets Highest Levels of Validation

DecisionDx-UM is the only prognostic test for uveal melanoma that has been clinically validated by an independent prospective, multi-center study, as well as multiple retrospective and prospective single-center studies. Nineteen peer-reviewed scientific publications, including analytical validation, clinical validation and clinical utility studies, support the clinical use of DecisionDx-UM. These studies are summarized below and are also listed in the Scientific References section.

Recommended in National Guidelines

NCCN

The National Comprehensive Cancer Network (NCCN), a group of the most recognized and respected comprehensive cancer centers in the U.S., evaluated the DecisionDx-UM test and included it in its first ever clinical guidelines for uveal melanoma in 2018. The NCCN guidelines include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommend different metastatic surveillance regimens based on a Class 1A, 1B, and 2 result.

AJCC

In addition, the American Joint Committee on Cancer (AJCC, version 8, 2018) recommends gene expression profile testing as part of clinical care because the results are “clinically significant.” DecisionDx-UM is the only clinically available gene expression profile test for use in uveal melanoma in the U.S.

Helps Physicians Match Surveillance Plan to Patient Risk

Clinical use of the DecisionDx-UM test has been well documented in both medical records review and in peer-reviewed scientific publications. The test’s primary clinical use is to inform risk-appropriate surveillance plans in accordance with a patient’s class result. Patients at low risk of metastasis, for instance, may receive a low-intensity surveillance program, such as alternating between the use of semiannual liver function tests and ultrasound or other imaging techniques. Patients at high risk for metastasis may receive a high-intensity surveillance program, such as quarterly magnetic resonance imaging (MRI) or computerized tomography (CT) scans, quarterly liver function tests, and referral to a medical oncologist for adjuvant treatment interventions.

Five published studies totaling 383 unique patients have shown that UM patients with a Class 1 tumor profile are commonly managed with a low intensity surveillance program while patients with a Class 2 tumor profile are managed with a high intensity surveillance program and may also receive adjuvant treatment. This is in line with current NCCN guidelines, which recommend the following screening frequency based on the DecisionDx-UM test result:

Class 1A Imaging should be considered
Class 1B Imaging considered every 6-12 months for 10 years (then as needed)
Class 2 Imaging considered every 3-6 months for 5 years and then 6-12 months for 10 years (then as needed)

Earlier Prognostic Methods Found to be Insufficient

Prior to the availability of the GEP test, patients were evaluated based on traditional cytopathology. A small number of clinics evaluated chromosome 3 status—largely using investigational techniques. Neither of these methods—the traditional cytopathology or chromosome 3 testing—provided sufficient information to accurately stage the risk of metastatic disease. As a result, patients were often given a “one-size-fits-all” surveillance plan, with strong potential for either undertreatment or overtreatment. In addition, because risk could not be precisely ascertained, many patients were not referred for adjuvant treatment.

The DecisionDx-UM assay was discovered, developed, and clinically validated by Dr. J. William Harbour while at Washington University in St. Louis. He is currently Professor of Ophthalmology, Vice Chairman for Translational Research and Director of the Ocular Oncology Service at the Bascom Palmer Eye Institute in Miami.

Castle Biosciences exclusively licensed the DecisionDx-UM assay from Washington University, completed technical validation studies, and subsequently made it available for routine clinical use through a CAP-accredited/CLIA-certified laboratory. It is only available through Castle Biosciences.

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