PRiMeUM is a model that provides a probability estimate of metastasis of uveal melanoma within 48 months after primary therapy, using clinical features and somatic chromosomal copy number status. This model is not designed to predict the risk of a local recurrence of uveal melanoma. The accuracy of the metastatic risk prediction ranges between 83% using clinical and tumor features only (age, sex, tumor location and size), and 85% (using clinical, tumor and chromosomal information). Therefore, PRiMeUM provides a probability which is not absolute and does not predict with 100% certainty the probability of uveal melanoma metastasis within 48 months. The dataset upon which the metastatic risk prediction is based consists of 1227 uveal melanoma cases managed by the Ocular Oncology Service at Wills Eye Hospital in Philadelphia, PA. This model has not been validated using populations in a different geographic location or treatment center; therefore there may be limitations to applying this prediction model to other populations. PRiMeUM versions may evolve over time to include a larger dataset or incorporation of new risk factors. The clinical and genetic features evaluated in this model are not exhaustive; there may be other genetic factors, clinical features, or environmental influences that are not evaluated in this risk prediction. Clinicians should use their professional judgment, based on the patient’s individual clinical information and the totality of known clinical information, while interpreting the probability results from PRiMeUM. Treatment, diagnostic, and other clinical decisions made using the information provided by this model are the responsibility of the clinician and patient. A healthcare professional should not rely solely or primarily on the results to make any clinical diagnosis or treatment decision regarding an individual patient, and PRiMeUM’s accuracy for any specific individual is not guaranteed.
PRiMeUM is only intended for use by a licensed healthcare provider with the knowledge, skill and experience regarding uveal melanoma to adequately understand and interpret the results. PRiMeUM is not intended to be used by a patient, family member, or other individual without the knowledge, skill and experience regarding uveal melanoma to adequately understand and interpret the results. PRiMeUM is not intended for use outside of the United States, or in any location where its use is prohibited by a regulatory or licensing agency. PRiMeUM is not intended for use in connection with the diagnosis or treatment of any individual residing outside of the United States. By using PRiMeUM, you represent that you are a healthcare provider located within the United States, have the licensure or other credentials required to understand and interpret the results from PRiMeUM, and are using PRiMeUM in connection with a patient residing within the United States.
The PRiMeUM model was developed in and performed at a CLIA-certified laboratory at the University of Pennsylvania, and has not been reviewed, submitted for review, or approved by the U.S. Food and Drug Administration, the U.S. Centers for Medicare and Medicaid, or any federal, state or local regulatory agency. The University of Pennsylvania is not responsible for any error or omission in connection with PRiMeUM, or any diagnosis or treatment decision made in reliance on its results, or how an individual uses PRiMeUM or its results.