Urine test shown to help as many as half of patients with Gleason 3+4 or higher avoid imaging and biopsies, researchers report

By Howard Wolinsky

An 18-gene urine test, known as MPS2 (My Prostate Score 2.0) can help men with Grade Group 2 (Gleason 3+4=7) or higher in many cases avoid imaging and biopsies while maintaining highly sensitive detection of high-grade cancers, researchers reported Thursday in JAMA Oncology.

MPS2 calculates a personalized risk score for prostate cancer based on genetic markers. The test is the only one on the market that detects the T2:ERG gene fusion, which is present in most men with prostate cancer. Analysis of these 18 genetic markers uncovers information not available through PSA screening.

Researchers said MPS2 would safely identify up to 51% of patients who would not have clinically significant prostate cancer found on biopsy, while maintaining high sensitivity for high-grade cancers. They also said MPS2 has a higher diagnostic accuracy for high-grade PCa 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. MPS2 is not a screening tool, nor is it intended to replace PSA. The MyProstateScore test is designed to provide additional information for patients who have undergone PSA testing.

The data support use of this new PCa biomarker test in patients with elevated PSA levels to reduce the potential harms of PCa screening, such as infections and sepsis, while preserving its long-term benefits.

In applying a testing approach with 95% sensitivity for high-grade prostate cancer (Grade Group [GG] 2 or greater), MPS2 would have safely avoided unnecessary additional testing with imaging or biopsy in 35% to 51% of men, with a negative predictive value (NPV) of 95% to 99%, reported Arul M. Chinnaiyan, MD, PhD, of the University of Michigan in Ann Arbor, and colleagues.

A NPV of 95% means a patient still has 5% likelihood of clinically significant cancer on biopsy after a negative MRI. The test is 99% sensitive for cancers of GG 3 (Gleason 4+3) or greater.

Chinnaiyan, director of the Michigan Center for Translational Pathology, said current commercial tests available for prostate cancer can detect the disease but are “not doing as good a job in detecting high-grade or clinically significant prostate cancer/” He said the MPS2 test will “address this unmet need.”

"These findings suggest that use of the test in patients with elevated PSA [prostate-specific antigen] levels can reduce the potential harms of prostate cancer screening while preserving its long-term benefits,” researchers said.

"We know that prostate cancer is very complicated, and every year we are discovering new markers and biologic aspects of prostate cancer," co-author John T. Wei, MD, also of the University of Michigan, told MedPage Today. "Tests get outdated and they're not incorporating new findings.

Lynx Dx is the Ann Arbor-based manufacturer of MPS2, which was developed from technology developed at the University of Michigan.

Lynx Dx Chief Medical Officer Spencer Heaton, MD, MBA, said: "Lynx Dx's goal is to provide best-in-class diagnostic tests that enable urologists and patients to make confident decisions, while greatly improving the rate of life-saving early detection."

(Dr. Spencer Heaton)

The company said the cost depends on the individual’s insurance. Many patients will pay nothing or only part of the cost.

For more information, contact Lync Dx (at (888) 978-8677, 8 a.m.-8 p.m. ET, Monday through Friday, or email them at clientservices@lynxdx.com. Chat at their website at www.lynxdx.com