By Ron Shinkman, Editor, Laboratory Industry Report
Massachusetts-based Exosome Diagnostics has released data from a clinical validation study suggesting its liquid biopsy test for prostate cancer patients could more accurately predict the presence of the disease than the current biopsy options that are available.
The current PSA test has issues with overall accuracy and cannot tell whether a case of prostate cancer is aggressive or not, often leading to cases of overtreatment. The Exosome assay requires a urine sample from men with PSA counts suggesting prostate issues but does not require a digital rectal exam.
According to the validation test, which studied men over the age of 50 who were scheduled to undergo a prostate biopsy, the Exosome assay had an accuracy rate of 91.3 percent and could distinguish between aggressive and non-aggressive forms of prostate cancer nearly 92 percent of the time.
“We are extremely encouraged by these results and the potential significance this liquid biopsy test may have for men with prostate cancer,” said Gerald L. Andriole, Jr., M.D., a study co-author and professor and chief of urology at Washington University School of Medicine, in a statement. “The current diagnostic standard of care for this disease is notoriously imprecise, leading to a significant number of unnecessary tissue biopsies and often unwarranted aggressive treatment. These data demonstrate the clinical utility of exosomes to reveal critical molecular information about the aggressiveness of prostate cancer.”
Exosome’s findings were presented this week at the annual American Urological Association conference.
The company has yet to announce when its test would be available to the public.