Aditxt's Pearsanta Receives Institutional IRB Approval From WCG Clinical To Initiate Prospective Clinical Study Evaluating Mitomic Endometriosis Test; Plans To Begin Patient Enrollment In May 2025

Prospective study to evaluate diagnostic performance and generate real-world data for the Mitomic® Endometriosis Test, a potential non-invasive approach 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 received Institutional Review Board (IRB) approval from WCG Clinical to initiate a 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 the gold standard for confirming endometriosis. Patient enrollment is expected to begin in May 2025. 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.

"IRB approval is a major milestone in our path to validate a diagnostic tool that we believe 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 deletions, MET is designed as a non-invasive alternative to current surgical diagnostic approaches, potentially 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 assess the feasibility of personalized diagnostic insights
• Establishing a biobank of clinical samples to enable future research, biomarker discovery and product development initiatives

"Endometriosis is an example of how early disease detection represents one of the most significant gaps in healthcare, with millions affected," said Amro Albanna, CEO of Aditxt. "This approval reflects Aditxt's commitment to addressing some of the most pressing health challenges through our subsidiaries and their programs."

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 mitochondrial DNA (mtDNA) biomarkers to detect molecular signatures associated with disease, potentially 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.