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Helps physicians match surveillance plan to patient risk
Clinical use of the DecisionDx-UM test has been well documented 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.
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Class 1A
LOW Risk
Imaging should be considered every 12 months for five years
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Class 1B
Intermediate Risk
Imaging considered every 6-12 months for 10 years (then as needed)
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Class 2
High risk
Imaging considered every 3-6 months for five 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 determine 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 and Chair of the Department of Ophthalmology at University of Texas Southwestern Medical Center.
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 CLIA certified, CAP-accredited and NY state approved laboratory. It is only available through Castle Biosciences.