DecisionDx-UM Documented Clinical Use

DecisionDx^®-UM
Documented Clinical Use

Healthcare Providers Use DecisionDx-UM to Direct Follow-Up Care

Before the availability of DecisionDx-UM testing, management recommendations included frequent imaging and liver function tests to monitor patients for metastatic disease; in this way, the overwhelming majority of UM patients were managed as high risk. With molecular classification based on DecisionDx-UM results, clinicians use a Class 1 designation to “rule out” high-risk patients, sparing them unnecessary surveillance and treatment, whereas only Class 2 patients, who are at a true high risk for metastasis, can be offered aggressive management strategies. The results of DecisionDx-UM also allow patient stratification for entry into clinical trials for adjuvant therapies, thereby reducing both the number of patients required and the amount of time necessary to achieve appropriate power to detect differences in outcomes.

Five decision impact studies totalling 383 patients have shown that use of DecisionDx-UM leads to clinically-appropriate, significant changes to patient management.

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 receive adjuvant treatment. Lower intensity programs may utilize bi-annual or annual LFTs and ultrasound, MRI or CT scans of the liver, while high intensity programs may recommend quarterly or bi-annual ultrasound, MRI or CT scans of the liver alternating with LFTs. Single- and multi-center studies in Europe have demonstrated the utility of prescribing bi-annual imaging and LFTs for metastatic surveillance of high-risk UM patients. In these studies, imaging was highly sensitive to detect metastases before the onset of symptoms, permitting surgical resection in some patients that led to improved survival compared to those not eligible for resection.

Summary of Clinical Utility Studies in Patients With DecisionDx-UM Testing

Study	Design	Number of Patients	Risk Classification Method	Results
Aaberg et al., 2020	Prospective, multi-center	89*	DecisionDx-UM	All (100%) patients with Class 2 tumors were maintained on high-intensity surveillance, while 80% of Class 1 patients had low-intensity surveillance (p<0.0001).
Schefler et al., 2020	Prospective, multi-center	138	DecisionDx-UM	93% of Class 2 patients were referred to medical oncology; Class 2 patients had more intensive surveillance (frequency and use of advanced imaging) than Class 1 patients.
Plasseraud et al., 2016	Prospective, multi-center	70	DecisionDx-UM	19% of Class 1 patients were managed with biannual-quarterly surveillance vs. 100% of Class 2 patients. 81% of Class 1 patients had lower intensity surveillance on a yearly schedule.
Aaberg et al., 2014	Retrospective, multi-center	88	DecisionDx-UM	0% of Class 1 patients were managed with bi-annual-quarterly surveillance vs. 100% Class 2 patients. All Class 1 patients had a reduced surveillance schedule.
Davanzo et al., 2019	Retrospective, single center	68	DecisionDx-UM	Class 1 patients were 9.5 times less likely to have expected surveillance performed compared with Class 2 patients.

*70 patients overlap with Plasseraud, 2016

Physicians Are Using DecisionDx-UM To:

Develop
Patient-Specific
Surveillance Plans

DecisionDx-UM allows physicians to develop customized metastatic surveillance plans—thus balancing the risks of radiation exposure and increased costs of advanced imaging with the patient’s risk of metastasis. Over 60% of tested patients have a low-risk (Class 1) molecular profile, which means a majority of patients would be switched from a default high-intensity surveillance regimen to a low-intensity program.

Initiate Referral
to a Medical
Oncologist

Initiate referral to a medical oncologist for treatment planning and options, which may include adjuvant treatment.

Identify
Candidates for
Clinical Trials

Refer appropriate high-risk patients to clinical trials.

Study Highlight: Impact of DecisionDx-UM on Treatment Plan Recommendations

A 2020 study published by Schefler and colleagues in Melanoma Management showed that the DecisionDx-UM test had a significant impact on treatment plan recommendations for patients with uveal melanoma.

The multicenter CLEAR II study (Clinical Application of DecisionDx-UM Gene Expression Assay Results II) was designed to prospectively evaluate physician referral practices and detailed metastatic surveillance plans for 138 UM patients who were tested with DecisionDx-UM as part of their diagnostic work up, and to compare management plans between low-risk (Class 1) and high-risk (Class 2) patients.

Summary of Results:

138 patients from nine centers were enrolled into the study.
93 patients (67%) had a low-risk Class 1 test result; and 45 patients (33%) had a high-risk Class 2 test result.
Medical oncology referral was more common for high-risk Class 2 patients than for low-risk Class 1 patients (p<0.001).
Class 1 patients were less likely to have their metastatic surveillance managed by a medical oncologist compared to Class 2 patients (p<0.001).
Patients with a Class 1 result were significantly less likely to receive recommendations for frequent (three or four times a year) surveillance imaging and liver function testing compared to Class 2 patients (p<0.001).
These findings show that treatment plan recommendations are aligned with metastatic risk and are consistent with results from previously published studies documenting the impact of DecisionDx-UM on patient management.

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