Endometriosis affects 5–10% of reproductive-age women and is a leading cause of infertility and chronic pelvic pain. Diagnosis is often delayed due to heterogeneous symptoms and limitations of imaging, with laparoscopic visualization remaining invasive and operator-dependent. We present the development of a novel multi-omic non-invasive AI-based blood test composed of 7 biomarkers (3 miRNAs, 3 proteins, and one hormone). Testing involved quantification of each biomarker by qPCR or immunoassay. CLIA laboratory validation was based on a random forest training set comprised 218 participants (137 endometriosis-positive, 81 negative controls) and validated on an independent cohort of 277 participants (157 positive, 120 controls). All participants were enrolled under IRB informed consent and provided 10mL of blood for serum isolation and analysis. The test achieved 0.95 AUC, 0.83 sensitivity, and 0.975 specificity across ethnically diverse participants, demonstrating robust generalizability. Compared with imaging, the blood test identified histologically confirmed true-positive cases (61.5%) missed by transvaginal ultrasound and/or MRI, highlighting its complementary diagnostic value in clinical settings. The results demonstrate that a noninvasive molecular blood test can detect endometriosis with high accuracy in confirming the presence of endometriosis when suspicion exists. This multi-omic assay represents a scalable diagnostic tool with the potential to shorten diagnostic delays for earlier detection, to aid timely intervention.

Farideh currently serves as the Chief Medical Officer of Heranova Life Sciences, Inc. and leads the development of clinical assays intended to address unmet needs in the areas of women’s health. Prior to joining Heranova, Farideh served in a number of executive roles focused on clinical translation and clinical validation of non-invasive blood based diagnostic assays in oncology and prenatal genetics. She’s clinically trained in human molecular genetics and cytogenetic, and has served as Professor in the Departments of Obstetrics and Gynecology, and Immunology at Baylor College of Medicine, where her visionary and influential work in fetal cells began as a key investigator on the NIH sponsored Fetal Cell (NIFTY) Study. Farideh is well known in the fields of circulating rare fetal and tumor cells/cell-free DNA as a source for non-invasive molecular diagnostic testing, with over 10,000 citations from 300 peer reviewed publications and book chapters.