The updated treatment algorithm includes EPI testing prior to a first prostate biopsy or after a negative biopsy to assist patients and urologists in further defining the probability of high-grade cancer and in reaching a joint decision to either proceed with a prostate biopsy or continue monitoring.
The NCCN Guidelines are the recognized clinical standard for cancer care by clinicians and payors in the United States. The guidelines are developed and revised by a panel of expert physicians from 28 leading U.S. cancer centers. The panel revises recommended practice guidelines according to current clinical evidence and advances in cancer care.
The EPI test has been studied in over 5,000 patients in the intended use population, men over 50 with a PSA result between 2 and 10. Strong results supporting the clinical diagnostic validity of the EPI test were confirmed in two large peer reviewed clinical studies published in JAMA Oncology 2016; 2(7):882-889 and European Urology 2018; 74(6):731-738. Since the EPI test’s national launch at the end of 2017, it has been ordered by more than 1100 practicing urologists in the US.
By using EPI to help assess a patient’s risk for high grade prostate cancer, urologists are better equipped to guide men in deciding whether an invasive prostate biopsy and related complications can be safely avoided or deferred. The US Preventative Services Task Force (USPSTF) reported there are serious side effects from biopsies including infection, diminished sexual function, incontinence, pain, hospitalization and even death. USPSTF also noted biopsies can drive treatment of low grade disease and the associated complications of treatment with no overall survival benefit for the patient.