RE: PHI or PSE Test - Results and Costs18 Oct 2024 09:20
New MPS2 Urine Test for Prostate Cancer in the USA
The new MPS2 urine test, developed by researchers at the University of Michigan, screens for 18 genetic markers that are highly associated with clinically significant prostate cancers – cancers that can grow quickly and should be monitored or treated – classified as grade group (GG) 2 and higher. The test is intended as an interim step before undergoing prostate biopsy among people who have an elevated PSA. For the test, men provide a urine sample at a clinic visit after DRE.
“This non-invasive test can serve as an added data point when discussing options with patients,” said senior author Arul Chinnaiyan, M.D., Ph.D., S.P. Hicks Endowed Professor of Pathology and Urology and director of the Michigan Center for Translational Pathology at the University of Michigan. “Approximately 75% of men who undergo biopsy do not have a cancer that needs to be treated. The MPS2 test provides additional information that can help avoid invasive biopsies and the discomfort and potential complications they bring.” A standard biopsy procedure involves systematically extracting 12 samples of prostate tissue from pre-specified areas of the gland.
To develop the MPS2 test, the team began by scanning a set of more than 58,000 potential genetic targets from pooled RNA sequencing data from the University of Michigan and the NCI’s The Cancer Genome Atlas. The panel was refined to a set of 54 candidate genes which, after running verification models, was whittled down to 17 genetic risk markers plus one reference gene, KLK3. The final MPS2 algorithm combines the 18 markers with other clinically relevant factors, such as age, race, and family history, to provide an overall result. Another version of the test, MPS2+, includes information about prostate volume in its algorithm.
The researchers then validated the assay using urine samples collected from 743 patients enrolled in an EDRN cohort of men who attended one of 11 academic sites for prostate biopsy. The samples went through MPS2 in addition to other clinically available prostate cancer biomarker tests for comparison. The results were then compared to patient biopsy results. They found that the MPS2 outperformed other validated prostate cancer biomarker tests at accurately identifying which patients had cancer detected at biopsy.
Further, the test showed a 95% sensitivity and negative predictive value (NPV) for GG2 cancers and 99% sensitivity and NPV for cancers GG3 and above. “This means that for someone who has a negative result, there is a very high confidence that no cancer is present,” said Chinnaiyan. The analysis estimates approximately 40% of unnecessary biopsies could be avoided using MPS2.
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