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May 18, 2018/News Releases

Cleveland Clinic-led Study Finds that More than 40 Percent of Prostate Biopsies Could Have Been Avoided with New Blood Test

Findings to be presented during 2018 Annual Meeting of the American Urological Association

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San Francisco: A multi-center study that validates the clinical performance of IsoPSA – a new blood test that has proven to be more accurate in predicting overall risk of prostate cancer than standard prostate-specific antigen (PSA) – will be presented during a special press conference at the 13th Annual Meeting of the American Urological Association (AUA) on May 18 in San Francisco.

Results showed that more than 40 percent of biopsies could have been avoided in both the preliminary study (45.1 percent) and validation study (47 percent), suggesting that use of IsoPSA may substantially reduce the need for biopsy, and may thus lower the likelihood of overdetection and overtreatment of nonlethal prostate cancer.

The study, Prospective Validation of the IsoPSATM Assay for Detection of High Grade Prostate Cancer, was conducted as a follow-up to early studies which demonstrated that IsoPSA, a structure-focused protein biomarker, may be an effective means of discriminating between high-grade prostate cancer (Gleason≥7) and low-grade/benign disease (Gleason=6).

Eric Klein, M.D., chair, Glickman Urological & Kidney Institute

The research team, led by Cleveland Clinic’s Eric Klein, M.D., conducted a multicenter validation trial and evaluated performance data with a new cohort, including cutoff parameters derived from a preliminary study, using the detection of cancer by biopsy as the endpoint.

“To be clinically useful, a biomarker must be both tissue-specific and cancer-specific. While PSA is prostate-specific, it is not specific for prostate cancer, leading to diagnostic inaccuracy and too many unneeded biopsies,” said Dr. Klein, chair of Cleveland Clinic’s Glickman Urological & Kidney Institute. “IsoPSA fulfills both the tissue- and cancer-specificity needed for a useful biomarker, and this validation study shows that it can more accurately detect high-grade cancer and reduce the rate of unneeded biopsies in patients at low risk of this disease.”

The IsoPSA test was developed by Cleveland Diagnostics, a company co-founded by Cleveland Clinic, in which it has financial interest. Dr. Klein has no personal financial interest in the company. Mark Stovsky. M.D., a Cleveland Clinic urologist and co-author on the study, has a leadership position (Chief Medical Officer) and investment interest in Cleveland Diagnostics. In late 2017, Cleveland Diagnostics and Genomic Health announced an exclusive licensing agreement to develop and commercialize the IsoPSA test.

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About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation, Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. Cleveland Clinic is consistently recognized in the U.S. and throughout the world for its expertise and care. Among Cleveland Clinic’s 83,000 employees worldwide are more than 6,600 salaried physicians and researchers, and 21,900 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,725-bed health system that includes a 173-acre main campus near downtown Cleveland, 23 hospitals, 300 outpatient facilities, including locations in northeast Ohio; Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2025, there were 15.9 million outpatient encounters, 343,000 hospital admissions and observations, and 336,000 surgeries and procedures throughout Cleveland Clinic’s health system. Visit us at clevelandclinic.org. Follow us at x.com/CleClinicNews. News and resources are available at newsroom.clevelandclinic.org.

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