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
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.
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, OTC: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 $17 million for Appili and $17 million for Evofem, which includes approximately $15.2 million required to satisfy Evofem's senior secured noteholder; should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. On Dec. 23, 2024, Evofem announced the cancellation of its special stockholders meeting and the withdrawal of the merger proposal with Aditxt from consideration by the stockholders. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company's intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company's ongoing and planned product and business development; the Company's ability to finance and execute its strategic M&A initiatives; the Company's ability to obtain the necessary funding and partner to commence clinical trials; the Company's intellectual property position; the Company's ability to develop commercial functions; expectations regarding product launch and revenue; the Company's results of operations, cash needs, spending, financial condition, liquidity, prospects, growth, and strategies; the Company's ability to raise additional capital; expected usage of the Company's ELOC and ATM facilities; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled "Risk Factors" in Aditxt's most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company's other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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