Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer

In a manuscript published this week in JAMA Oncology, senior author Dr. Arul Chinnaiyan and members of the EDRN-PCA3 Study Group reported on their development and validation of a new 18-gene urine-based test for diagnosis of high-grade prostate cancer, MPS2. This test was initially developed in the Department of Pathology. 

Existing testing for prostate cancer results in a significant number of false positives, leading to numerous unnecessary prostate biopsies, which are invasive and painful for patients. To improve upon existing prostate cancer tests, Chinnaiyan and the EDRN-PCA3 cohort undertook a study to identify genomic  markers for high grade prostate cancers and developed a panel of 18 genes, the MPS2 test, that showed a 95% sensitivity level for Grade Group 2 prostate cancers and 99% sensitivity for Grade Group 3 prostate cancers.

Per Chinnaiyan, “This new 18-gene MPS2 test has higher diagnostic accuracy for high-grade prostate cancer relative to existing biomarker tests. Clinically, use of this test would have meaningfully reduced unnecessary biopsies performed while maintaining highly sensitive detection of high-grade cancers. These data support use of this new prostate cancer biomarker test in patients with elevated PSA levels to reduce the potential harms of prostate cancer screening while preserving its long-term benefits.” In the clinical setting, this test offers primary care physicians a straightforward pathway for their patients. A negative test rules out high-grade disease while a positive test indicates referral to a specialist. The specialist benefits from the 18-gene panel results which may guide the next step in assessment of the patient which could include imaging and/or biopsy. 

Citation:

Tosoian JJ, Zhang Y, Xiao L, et al. Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer. JAMA Oncol. Published online April 18, 2024. doi:10.1001/jamaoncol.2024.0455