Grant: Project Grant

Endometriosis is an estrogen-dependent disease characterized by chronic pelvic pain and infertility. Pelvic pain in affected women has been linked with serious deleterious effects on social functioning, emotional well-being, relationships with medical practitioners, and employment. Women with endometriosis experience lengthy delays of 5.3 to 12 years before obtaining a definitive diagnosis. Before diagnosis women with endometriosis reported up to 5 doctor and 2 emergency room visits to manage their undiagnosed pelvic pain. The current gold standard for diagnosis remains direct visualization of endometriosis through laparoscopy. Demand from patients and health care providers for earlier non-surgical diagnosis and non-invasive diagnostic tools has been increasing. Therefore, an urgent unmet need to identify novel clinical markers of endometriosis remains. Our team aims to disrupt the current diagnostic landscape for women with pelvic pain. We have shown that circulating microRNA (miRNA) in blood can be used to reproducibly diagnose endometriosis with sensitivity and specificity comparable to laparoscopy. The technology is patent protected and licensed to AIMA Laboratories, a new McMaster University spinoff company created to bring this test to market. Working together, AIMA Laboratories, McMaster University, and doctors from across Canada will demonstrate the clinical validity of the diagnostic test and develop data necessary to meet regulatory approvals in Canada and the United States to bring this test to market. We hypothesize that the diagnostic markers of endometriosis included in our test can successfully detect endometriosis with accuracy equivalent to surgery. We predict that results of this project will accelerate regulatory approvals, licensing of the test, and commercial launch throughout North America. A positive test will empower women by validating the painful symptoms felt by women with pelvic pain and will shorten time to diagnosis of endometriosis.