Prospective study to evaluate diagnostic performance and generate real-world data for the Mitomic® Endometriosis Test, a non-invasive alternative to surgical diagnosis for endometriosis

Aditxt, Inc. (Nasdaq: ADTX) ("Aditxt" or the "Company"), a social innovation platform accelerating promising health innovations, today announced that its subsidiary, Pearsanta, Inc. ("Pearsanta"), has begun enrollment in their prospective clinical study evaluating the Mitomic^® Endometriosis Test (MET™), a novel blood-based diagnostic designed to aid in the early detection of endometriosis.

The study, “Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting with Symptoms of Endometriosis,” is designed to evaluate the clinical performance of MET™ 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, located in Dover, DE, is now beginning enrollment. “This very exciting research could allow women to obtain an accurate diagnosis of endometriosis approximately 2-3 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 Investigator of the site.

“This represents another major milestone in our path to validate a diagnostic tool that addresses a critical gap in women’s health,” said Chris Mitton, President of Pearsanta. “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.”

Study objectives include:

• Evaluating the sensitivity and specificity of the Mitomic^® Endometriosis Test 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,” said Amro Albanna, Co-founder and Chief Executive Officer of Aditxt. “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 1 in 10 women globally, yet diagnosis can take 7 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.

The study is registered on ClinicalTrials.gov under identifier NCT06907550. 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, Virginia.

About Aditxt

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 unique 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.

About Pearsanta

Pearsanta is at the forefront of precision health, focusing 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 a range of other innovative diagnostic technologies, all aimed at transforming early disease detection and monitoring, enabling more informed treatment decisions and ultimately improving patient outcomes. For more information, please visit www.pearsanta.com.

Forward-looking statements

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