Aditxt Subsidiary Pearsanta Receives IRB Approval to Initiate Clinical Study of Blood-Based Diagnostic for Endometriosis with Patient Enrollment Planned to Begin in May 2025
Aditxt (NASDAQ: ADTX) announced that its subsidiary Pearsanta has received IRB approval to begin a clinical study for the Mitomic® Endometriosis Test (MET), a blood-based diagnostic tool for endometriosis detection. The study will evaluate MET's performance against laparoscopic diagnosis, enrolling up to 1,000 participants starting May 2025.
The study aims to assess MET's sensitivity and specificity across disease subtypes, explore correlations between test results and symptoms, and establish a biobank for future research. MET utilizes mitochondrial DNA biomarkers to detect disease signatures through a simple blood draw, potentially offering a non-invasive alternative to surgical diagnosis.
Endometriosis affects 1 in 10 women globally, with diagnosis typically taking 7-10 years due to current diagnostic limitations. The study results will support MET's launch as a Laboratory Developed Test at Pearsanta's CLIA/CAP-certified laboratory in Richmond, Virginia.
Aditxt (NASDAQ: ADTX) ha annunciato che la sua controllata Pearsanta ha ottenuto l'approvazione dell'IRB per avviare uno studio clinico sul Mitomic® Endometriosis Test (MET), un test diagnostico basato sul sangue per la rilevazione dell'endometriosi. Lo studio valuterà l'efficacia del MET rispetto alla diagnosi laparoscopica, arruolando fino a 1.000 partecipanti a partire da maggio 2025.
L'obiettivo dello studio è analizzare la sensibilità e specificità del MET nelle diverse forme della malattia, esaminare le correlazioni tra i risultati del test e i sintomi, e creare una biobanca per ricerche future. Il MET utilizza biomarcatori del DNA mitocondriale per identificare le caratteristiche della malattia tramite un semplice prelievo di sangue, offrendo potenzialmente un'alternativa non invasiva alla diagnosi chirurgica.
L'endometriosi colpisce 1 donna su 10 nel mondo, con una diagnosi che solitamente richiede 7-10 anni a causa delle limitazioni degli attuali metodi diagnostici. I risultati dello studio sosterranno il lancio del MET come test sviluppato in laboratorio presso il laboratorio certificato CLIA/CAP di Pearsanta a Richmond, Virginia.
Aditxt (NASDAQ: ADTX) anunció que su subsidiaria Pearsanta ha recibido la aprobación del IRB para iniciar un estudio clínico del Mitomic® Endometriosis Test (MET), una herramienta diagnóstica basada en sangre para la detección de la endometriosis. El estudio evaluará el desempeño del MET frente al diagnóstico laparoscópico, reclutando hasta 1,000 participantes a partir de mayo de 2025.
El estudio tiene como objetivo evaluar la sensibilidad y especificidad del MET en diferentes subtipos de la enfermedad, explorar las correlaciones entre los resultados del test y los síntomas, y establecer un biobanco para futuras investigaciones. El MET utiliza biomarcadores del ADN mitocondrial para detectar señales de la enfermedad mediante una simple extracción de sangre, ofreciendo potencialmente una alternativa no invasiva al diagnóstico quirúrgico.
La endometriosis afecta a 1 de cada 10 mujeres a nivel mundial, y el diagnóstico generalmente tarda entre 7 y 10 años debido a las limitaciones de los métodos actuales. Los resultados del estudio respaldarán el lanzamiento del MET como un test desarrollado en laboratorio en el laboratorio certificado CLIA/CAP de Pearsanta en Richmond, Virginia.
Aditxt (NASDAQ: ADTX)의 자회사 Pearsanta가 Mitomic® 자궁내막증 검사(MET) 임상시험을 시작하기 위해 IRB 승인을 받았다고 발표했습니다. 이 혈액 기반 진단 도구는 자궁내막증을 감지하며, 본 연구는 2025년 5월부터 최대 1,000명의 참가자를 모집해 복강경 진단과 MET의 성능을 비교 평가할 예정입니다.
연구 목표는 MET의 민감도와 특이도를 질병 유형별로 평가하고, 검사 결과와 증상 간의 상관관계를 탐색하며, 향후 연구를 위한 바이오뱅크를 구축하는 것입니다. MET는 미토콘드리아 DNA 바이오마커를 활용해 간단한 혈액 채취만으로 질병 특성을 감지하여 수술적 진단에 대한 비침습적 대안이 될 수 있습니다.
자궁내막증은 전 세계 여성 10명 중 1명에게 영향을 미치며, 현재 진단 방법의 한계로 인해 보통 7~10년이 걸립니다. 이번 연구 결과는 Pearsanta의 CLIA/CAP 인증 실험실(버지니아주 리치먼드)에서 실험실 개발 검사로서 MET 출시를 지원할 것입니다.
Aditxt (NASDAQ: ADTX) a annoncé que sa filiale Pearsanta a obtenu l'approbation de l'IRB pour lancer une étude clinique sur le Mitomic® Endometriosis Test (MET), un outil diagnostique sanguin pour la détection de l'endométriose. L'étude évaluera la performance du MET par rapport au diagnostic laparoscopique, en recrutant jusqu'à 1 000 participants à partir de mai 2025.
L'objectif de l'étude est d'évaluer la sensibilité et la spécificité du MET selon les sous-types de la maladie, d'explorer les corrélations entre les résultats du test et les symptômes, et de constituer une biobanque pour des recherches futures. Le MET utilise des biomarqueurs de l'ADN mitochondrial pour détecter les signatures de la maladie via une simple prise de sang, offrant potentiellement une alternative non invasive au diagnostic chirurgical.
L'endométriose touche 1 femme sur 10 dans le monde, avec un diagnostic qui prend généralement entre 7 et 10 ans en raison des limites des méthodes actuelles. Les résultats de l'étude soutiendront le lancement du MET en tant que test développé en laboratoire dans le laboratoire certifié CLIA/CAP de Pearsanta à Richmond, Virginie.
Aditxt (NASDAQ: ADTX) gab bekannt, dass seine Tochtergesellschaft Pearsanta die IRB-Zulassung erhalten hat, um eine klinische Studie für den Mitomic® Endometriosis Test (MET) zu starten, ein blutbasiertes Diagnoseinstrument zur Erkennung von Endometriose. Die Studie wird die Leistung des MET im Vergleich zur laparoskopischen Diagnose bewerten und bis zu 1.000 Teilnehmer ab Mai 2025 einschließen.
Ziel der Studie ist es, die Sensitivität und Spezifität des MET bei verschiedenen Krankheitsuntertypen zu untersuchen, Zusammenhänge zwischen Testergebnissen und Symptomen zu erforschen und eine Biobank für zukünftige Forschungen aufzubauen. MET nutzt mitochondriale DNA-Biomarker, um Krankheitssignaturen durch eine einfache Blutentnahme zu erkennen und bietet somit möglicherweise eine nicht-invasive Alternative zur chirurgischen Diagnose.
Endometriose betrifft 1 von 10 Frauen weltweit, wobei die Diagnose aufgrund der aktuellen diagnostischen Einschränkungen typischerweise 7-10 Jahre dauert. Die Studienergebnisse werden die Einführung des MET als Labor entwickelten Test im CLIA/CAP-zertifizierten Labor von Pearsanta in Richmond, Virginia, unterstützen.
- Received IRB approval to begin clinical trials for novel blood-based endometriosis diagnostic
- Large-scale study with 1,000 participants targeting significant market (1 in 10 women globally)
- Potential to reduce diagnosis time from current 7-10 years through non-invasive testing
- Development of proprietary Mitomic Technology for disease detection
- Clinical trial results not expected until after May 2025
- No current revenue generation from the diagnostic test
- Faces competition from existing diagnostic methods (laparoscopy)
- Success of the diagnostic test not guaranteed
Insights
Aditxt's subsidiary Pearsanta has secured a critical development milestone with IRB approval for its Mitomic® Endometriosis Test (MET) clinical study. This 1,000-patient prospective study represents a significant step in the diagnostic development pathway, though it's important to note this is an early clinical validation phase rather than a market-ready achievement.
The study design comparing MET against laparoscopy (the current gold standard) is methodologically sound, targeting the right endpoints: sensitivity, specificity across disease subtypes, and correlation with symptom profiles. Pursuing the Laboratory Developed Test (LDT) regulatory pathway through their CLIA/CAP-certified lab creates a potentially faster route to commercialization compared to traditional FDA clearance processes.
From a technical perspective, MET's focus on mitochondrial DNA deletions as biomarkers offers a novel approach to a persistent diagnostic challenge. The technology aims to address a fundamental bottleneck in women's healthcare where diagnosis currently takes 7-10 years, primarily due to the invasive nature of surgical confirmation. A non-invasive blood-based test with sufficient accuracy could dramatically compress this timeline.
With enrollment beginning May 2025, we should anticipate at least 12-18 months before meaningful clinical validation data becomes available. Investors should view this as a promising but early-stage asset within Aditxt's innovation portfolio that addresses a substantial unmet need affecting approximately 10% of women globally.
The IRB approval for Pearsanta's endometriosis diagnostic study addresses one of the most significant challenges in women's reproductive health. The current diagnostic paradigm—requiring invasive laparoscopic surgery—creates an unacceptable 7-10 year average delay between symptom onset and definitive diagnosis.
This diagnostic gap has profound clinical consequences: prolonged pain, irreversible organ damage, and untreated infertility. The indirect costs extend beyond direct medical expenses to lost productivity, diminished quality of life, and psychological impact.
MET's approach targeting mitochondrial DNA biomarkers represents a mechanistically sound diagnostic strategy. While several endometriosis biomarkers have been investigated historically, none have demonstrated sufficient accuracy to replace surgical diagnosis. The key metric to watch from this study will be MET's sensitivity across all disease stages, particularly for early-stage endometriosis when intervention could prevent disease progression.
The study's inclusion of symptom correlations and demographic variables suggests Pearsanta recognizes the heterogeneous presentation of endometriosis. This could potentially lead to personalized diagnostic insights that account for different disease subtypes and presentations. The establishment of a biobank for future research also demonstrates longer-term strategic thinking beyond this initial diagnostic application.
If validated, a non-invasive blood test could fundamentally transform the endometriosis care pathway, potentially enabling earlier intervention and more appropriate treatment selection for millions of patients.
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
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
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.
About Aditxt
Aditxt, Inc. ® is a social innovation platform dedicated to 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.
Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. ("Appili") (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. ("Evofem") (OTCQB: EVFM). Each program will be designed to function autonomously while collectively advancing Aditxt’s mission of discovering, developing and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately
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Aditxt, Inc.
Corporate Communications
Jeff Ramson, PCG Advisory, Inc.
T: 646-863-6893
Source: Aditxt, Inc.
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