Documented Clinical Use
|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
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.
to a Medical
Initiate referral to a medical oncologist for treatment planning and options, which may include adjuvant treatment.
Refer appropriate high-risk patients to clinical trials.