Aditxt Inc. subsidiary Pearsanta Inc. has begun enrolling patients in its prospective clinical study evaluating the Mitomic Endometriosis Test (MET), a blood-based diagnostic for early endometriosis detection.

The study, “Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting with Symptoms of Endometriosis,” is designed to evaluate MET’s clinical performance compared to laparoscopic diagnosis, which is currently considered the gold standard for confirming endometriosis. The prospective study will enroll up to 1,000 participants who are referred for diagnostic laparoscopy. Each participant will complete a symptom questionnaire and provide a pre-operative blood sample.

The first participating clinical site, Dedicated to Women OB/GYN in Dover, Del., has begun enrollment. “This very exciting research could allow women to obtain an accurate diagnosis of endometriosis approximately two to three years sooner on average and begin more targeted therapy for their disease process than is currently available. We at Dedicated to Women are honored to team with Pearsanta to bring this groundbreaking technology to the women of Delaware,” said Dr. Robert Hartmann, principal site investigator.

Study objectives include:

• Evaluating the Mitomic Endometriosis Test’s sensitivity and specificity in detecting endometriosis compared to laparoscopic diagnosis
• Assessing test performance across various disease subtypes to understand its utility in different clinical presentations
• Exploring correlations between MET results, symptom profiles, and demographic variables to support personalized diagnostic insights
• Establishing a biobank of clinical samples to enable future research, biomarker discovery and product development initiatives

“Advancing our subsidiary Pearsanta into human trials marks an important milestone,” Aditxt Co-Founder/CEO Amro Albanna stated. “Delays in diagnosing conditions such as endometriosis represent some of the most critical gaps in women’s health, affecting millions with few reliable diagnostic options. This milestone underscores our mission-driven approach to developing businesses that address major global health challenges.”

Endometriosis affects an estimated one in 10 women globally, yet diagnosis can take seven to 10 years on average due to the invasive nature of laparoscopy and lack of accurate, non-invasive tests. This diagnostic delay can lead to chronic pain, infertility and irreversible organ damage. Pearsanta’s MET leverages its proprietary Mitomic Technology, which utilizes mtDNA biomarkers to detect molecular signatures associated with disease, enabling earlier detection through a simple blood draw.

Results from this clinical trial are intended to support the launch of MET as a Laboratory Developed Test (LDT) within Pearsanta’s CLIA/CAP-certified laboratory in Richmond, Va.

“This represents another major milestone in our path to validate a diagnostic tool that addresses a critical gap in women’s health,” Pearsanta President Chris Mitton commented. “ This study will generate real-world data on the clinical performance of MET in a pre-surgical population, helping us evaluate its accuracy across symptom profiles and disease subtypes. By targeting mitochondrial DNA (mtDNA) deletions, MET is designed as a non-invasive alternative to current surgical diagnostic approaches, bringing us closer to delivering earlier, more accessible detection for patients affected by endometriosis.”

Aditxt, Inc. is a social innovation platform accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives its mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a model that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress. The company currently operates four programs focused on autoimmunity, cancer and early diseases detection, infectious diseases, and women’s health.

Pearsanta focuses on early cancer detection through advanced diagnostic technologies. Its proprietary Mitomic Technology Platform leverages the unique properties of mitochondrial DNA to detect cancer and other diseases with high accuracy via non-invasive, blood-based liquid, biopsy tests. Pearsanta’s asset portfolio also includes other innovative diagnostic technologies aimed at transforming early disease detection and monitoring, enabling more informed treatment decisions, and improving patient outcomes.