CLEVELAND, Ohio (Ivanhoe Newswire)— Every year, 1.3 million men in the United States undergo biopsies to determine if they have prostate cancer. Doctors usually recommend a biopsy if a man’s PSA level is four or higher. But the PSA screening test alone can’t determine if a man has cancer or something else. More on a new lab test that could eliminate unnecessary biopsies.
For men age 50 and over, the PSA or prostate-specific antigen blood test, has been the recommended screening test for prostate cancer for years. It’s also a test that some experts have criticized because of the chance for false positive results. Now, scientists are studying a new lab test that is proving to be more accurate.
“It’s a new way of measuring all the different abnormal proteins that result when cancer occurs as opposed to the normal proteins when PSA goes up because of non-cancerous prostate enlargement,” explained Eric Klein, MD, chair of Glickman Urological & Kidney Institute at Cleveland Clinic.
Cleveland Clinic researchers studied the IsoPSA test in two separate studies and found more than forty percent of biopsies could have been avoided. Down the road, it could change clinical practice.
“So IsoPSA adds to the toolbox because it will allow us to more accurately identify men at highest risk for high-grade cancers and only do biopsies in those patients and avoid biopsies in patients who don’t really need a biopsy,” elaborated Dr. Klein.
For men, that eliminates unnecessary procedures and adds to their peace of mind.
IsoPSA is now commercially available in select areas across the U.S. The company that developed the test, Cleveland Diagnostics, is preparing an application for FDA approval that should be considered by the agency in the first quarter of this year (2021). If the FDA approves the test, it’s likely it will gain coverage by insurance companies. Right now, the IsoPSA is available at certain U.S. hospitals and clinics with a 450-dollar out-of-pocket cost for the patient.