The goal is to develop a high-prostate-specific antigen (PSA) reflex test to accurately predict the presence of high-grade cancer — as measured by a Gleason score of 7 or above — before patients are subjected to a prostate biopsy.
This will help reduce the number of unnecessary biopsies that are requested in the United States and optimize healthcare spending for the 4 million men who receive a PSA score between 2 and 10 each year.
A current problem with prostate biopsies is that about 75% of results are either negative or indicate low probability of high-grade cancer. These results make most of the biopsies redundant and represent an unneeded financial and emotional burden on patients.
The partnering companies will focus on Cleveland Diagnostics’ proprietary IsoPSA Technology, a reagent that scans the entire spectrum of structural changes, or isoforms, of complex PSA protein.
After Genomic acquires exclusive rights to the technology, the company will sell it as an in vitro diagnostic blood-based test. IsoPSA can also be integrated into the workflow of any urology laboratory to distinguish patients with cancer from patients with benign enlargements of the prostate. This approach should allow for more precise results than PSA testing alone.
“Our research has shown that IsoPSA offers improved accuracy for identifying men at risk of high-grade disease, which will address one of the main limitations of standard PSA assays by reducing the over-diagnosis of low-grade, indolent cancers,” Eric L. Klein, MD, chair of the Glickman Urological and Kidney Institute at Cleveland Clinic, said in a press release. “Use of IsoPSA is likely to reduce unneeded biopsies, for the benefit of both patients and clinicians.”
The research Klein mentions includes a multicenter prospective trial of the IsoPSA reagent led by Cleveland Clinic.
The study titled, “The Single-parameter, Structure-based IsoPSA Assay Demonstrates Improved Diagnostic Accuracy for Detection of Any Prostate Cancer and High-grade Prostate Cancer Compared to a Concentration-based Assay of Total Prostate-specific Antigen: A Preliminary Report,” was recently published in the journal European Urology.
In this study, IsoPSA was shown to significantly improve diagnostic accuracy over PSA testing in both determining the presence of prostate cancer and in identifying patients at risk for high-grade disease.
Overall, 48% fewer false-positive biopsies were achieved with IsoPSA in a group selected to determine the need for biopsy, and 45% fewer false-positive rates were found in a group selected to identify men at low-risk of high-grade disease.
Cleveland Diagnostics researchers are now conducting a follow-up multicenter clinical trial in 250 patients to confirm these findings. The study likely will be completed in the first half of 2018.
“With the rapid development of costly therapies for late-stage cancer in concert with diminishing healthcare system resources, patients, physicians and payers are increasingly focused on clinically actionable and affordable diagnostics – especially on tools that target early clinical decisions,” said Arnon Chait, PhD, chief executive officer of Cleveland Diagnostics.
Under the terms of the agreement, Genomic should bring additional development and clinical validation data of the first high-PSA reflex test in 2018 to provide initial access to U.S. urology labs by 2020.