Genomic Health and Cleveland Diagnostics Partner to Develop New Prostate Cancer Tests

Genomic Health and Cleveland Diagnostics Partner to Develop New Prostate Cancer Tests
Genomic Health and Cleveland Diagnostics have entered into a global licensing agreement to develop and commercialize new prostate cancer tests based on the latter company’s IsoPSA technology. 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 o
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