Imagine experiencing chronic pelvic pain, heavy menstrual bleeding, and infertility, only to wait years for a definitive diagnosis. For millions of women suffering from endometriosis, this scenario is a reality. However, a new diagnostic innovation promises to change this narrative. Kephera Diagnostics has introduced EndomTest, the first commercially available non-invasive diagnostic test for endometriosis in the United States. This groundbreaking tool utilizes a simple blood test to identify the presence of the condition, potentially transforming the diagnostic landscape for this often-misunderstood disease.
Understanding Endometriosis
Endometriosis is a chronic gynecological condition affecting approximately 10% of women of reproductive age, or about 6.5 million individuals in the United States. Characterized by the growth of endometrial-like tissue outside the uterus, the disease leads to symptoms such as pelvic pain, painful menstruation, and infertility. The impact on quality of life can be profound, yet the path to diagnosis is fraught with delays. Currently, the gold standard for diagnosing endometriosis is laparoscopy, an invasive surgical procedure that carries risks and requires significant recovery time. On average, it takes seven years from symptom onset for patients to receive a diagnosis.
What is EndomTest?
EndomTest represents a significant advancement in diagnostic technology for endometriosis. Developed as a laboratory-developed test (LDT), it requires only a blood sample, making it a non-invasive alternative to traditional methods. The test incorporates two serum biomarkers—cancer antigen 125 (CA125) and brain-derived neurotrophic factor (BDNF)—alongside six clinical variables derived from a patient’s medical history. These variables include factors such as surgical history, severity of menstrual pain, and age at diagnosis of ovarian cysts. By analyzing these markers through a sophisticated diagnostic algorithm, the test provides a binary outcome: positive or negative for endometriosis.
Validation and Performance
EndomTest underwent rigorous validation using samples from the Oxford Endometriosis CaRe Centre biobank in the United Kingdom. The development study included 204 patients, while an external validation study encompassed 79 patients. Diagnoses in both cohorts were confirmed through laparoscopy and histological evaluation. The test demonstrated a specificity of 100% and a sensitivity of 46.2%, highlighting its utility as a rule-in test. Importantly, it showed promise in detecting deep infiltrating endometriosis (DIE) and endometriomas, conditions that are challenging to diagnose through imaging alone.
Patient Impact
For individuals like Sarah, a 33-year-old woman who endured years of unexplained pain before receiving a diagnosis, EndomTest offers hope. “If this test had been available earlier, I could have avoided so much uncertainty and started treatment sooner,” she reflects. By providing a less invasive diagnostic option, the test has the potential to reduce delays, alleviate patient anxiety, and enable earlier intervention, ultimately improving outcomes.
Expert Perspectives
Dr. Michael Krychman, a leading gynecologist from the University of California Irvine Medical Center, underscores the significance of this innovation: “EndomTest represents a paradigm shift in how we approach endometriosis diagnosis. By offering a non-invasive option, we can reach more patients earlier, facilitating timely treatment and improving quality of life.”
Future Directions
While the introduction of EndomTest is a monumental step forward, there is still work to be done. Researchers and clinicians aim to refine the test to enhance sensitivity further and expand its accessibility. Additionally, integrating this tool into routine clinical practice will require education and awareness efforts among healthcare providers and patients alike.
Conclusion
Endometriosis has long been a challenging condition to diagnose and manage, but innovations like EndomTest signal a brighter future. By reducing diagnostic delays and offering a non-invasive alternative, this test has the potential to transform care for millions of women. As awareness and adoption grow, EndomTest could mark the beginning of a new era in endometriosis diagnosis and treatment.
References
- Kephera Diagnostics. First Blood Test for Endometriosis Launched by Kephera Diagnostics. Kephera. July 24, 2025. Accessed July 24, 2025. https://kephera.com/first-blood-test-for-endometriosis-launched-by-kephera-diagnostics/
- Herranz-Blanco B, Daoud E, Viganò P, García-Velasco JA, Colli E. Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables. Biomolecules. 2023;13(7):1052. doi:https://doi.org/10.3390/biom13071052IF: 4.8 Q1
- Daoud E, Archer DF, Fabio Parazzini, Bárbara Herranz-Blanco. Validation of an In Vitro Diagnostic Test for Endometriosis: Impact of Confounding Medical Conditions and Lesion Location. International Journal of Molecular Sciences. 2024;25(14):7667-7667. doi:https://doi.org/10.3390/ijms25147667
