Aditxt’s Subsidiary Pearsanta to Collaborate with Evofem Biosciences for Targeted U.S. Launch of Endometriosis Diagnostic in Mid-2025
Aditxt, Inc. (NASDAQ: ADTX) announced that its subsidiary, Pearsanta, has entered into a collaboration agreement with Evofem Biosciences for the U.S. launch of a blood-based diagnostic test for endometriosis in mid-2025. The Mitomic® Endometriosis Test (MET™) detects a specific deletion in mitochondrial DNA, a novel biomarker for endometriosis.
Endometriosis affects approximately 190 million women worldwide, with no current validated blood-based tests available. The collaboration aims to develop a go-to-market strategy and commercial plan for MET. Over 300 endometriosis cases have been evaluated using MET, with 600 planned for clinical validation.
This partnership aligns with Evofem's strategy to expand its women's health product offerings and Aditxt's goal of accelerating healthcare innovations. The collaboration may also lead to future tests, such as early detection of ovarian cancer.
Aditxt, Inc. (NASDAQ: ADTX) ha annunciato che la sua controllata, Pearsanta, ha stipulato un accordo di collaborazione con Evofem Biosciences per il lancio negli Stati Uniti di un test diagnostico basato su sangue per l'endometriosi previsto per metà del 2025. Il Mitomic® Endometriosis Test (MET™) rileva una specifica delezione nel DNA mitocondriale, un biomarcatore innovativo per l'endometriosi.
L'endometriosi colpisce circa 190 milioni di donne in tutto il mondo, senza test validati attualmente disponibili basati su sangue. La collaborazione mira a sviluppare una strategia di accesso al mercato e un piano commerciale per il MET. Sono stati valutati oltre 300 casi di endometriosi utilizzando il MET, con 600 casi previsti per la convalida clinica.
Questa partnership è in linea con la strategia di Evofem di espandere la sua offerta di prodotti per la salute delle donne e con l'obiettivo di Aditxt di accelerare le innovazioni nel settore sanitario. La collaborazione potrebbe anche portare a futuri test, come la rilevazione precoce del cancro ovarico.
Aditxt, Inc. (NASDAQ: ADTX) anunció que su subsidiaria, Pearsanta, ha llegado a un acuerdo de colaboración con Evofem Biosciences para el lanzamiento en EE. UU. de un test diagnóstico basado en sangre para la endometriosis a mediados de 2025. La Prueba de Endometriosis Mitomic® (MET™) detecta una eliminación específica en el ADN mitocondrial, un biomarcador novedoso para la endometriosis.
La endometriosis afecta aproximadamente a 190 millones de mujeres en todo el mundo, sin pruebas válidas basadas en sangre actualmente disponibles. La colaboración tiene como objetivo desarrollar una estrategia de comercialización y un plan comercial para el MET. Se han evaluado más de 300 casos de endometriosis utilizando el MET, con 600 planificados para validación clínica.
Esta asociación se alinea con la estrategia de Evofem de expandir su oferta de productos de salud para mujeres y el objetivo de Aditxt de acelerar las innovaciones en salud. La colaboración también podría llevar a futuros tests, como la detección temprana del cáncer de ovario.
Aditxt, Inc. (NASDAQ: ADTX)는 자회사 Pearsanta가 Evofem Biosciences와 협력 계약을 체결했다고 발표했습니다. 이 계약은 2025년 중반에 미국에서 혈액 기반의 자궁내막증 진단 테스트를 출시하기 위한 것입니다. Mitomic® 자궁내막증 테스트(MET™)는 자궁내막증을 위한 새로운 바이오마커인 미토콘드리아 DNA의 특정 결실을 감지합니다.
자궁내막증은 전 세계적으로 약 1억 9천만 명의 여성에게 영향을 미치며 현재 유효한 혈액 기반 테스트는 제공되지 않고 있습니다. 협력의 목표는 MET에 대한 시장 진입 전략과 상업 계획을 개발하는 것입니다. MET를 사용하여 300건 이상의 자궁내막증 사례가 평가되었으며, 600건이 임상 검증을 위해 계획되어 있습니다.
이번 파트너십은 Evofem의 여성 건강 제품 확대 전략 및 Aditxt의 의료 혁신 가속화 목표와 일치합니다. 이 협력은 또한 조기 난소암 검출과 같은 향후 테스트로 이어질 수 있습니다.
Aditxt, Inc. (NASDAQ: ADTX) a annoncé que sa filiale, Pearsanta, a conclu un accord de collaboration avec Evofem Biosciences pour le lancement aux États-Unis d'un test diagnostique sanguin pour l'endométriose prévu pour mi-2025. Le Test d'Endométriose Mitomic® (MET™) détecte une délétion spécifique dans l'ADN mitochondrial, un biomarqueur novateur pour l'endométriose.
L'endométriose touche environ 190 millions de femmes dans le monde, sans tests sanguins validés actuellement disponibles. La collaboration vise à développer une stratégie de mise sur le marché et un plan commercial pour le MET. Plus de 300 cas d'endométriose ont été évalués à l'aide du MET, avec 600 prévus pour la validation clinique.
Ce partenariat s'aligne avec la stratégie d'Evofem d'élargir son offre de produits de santé pour les femmes et l'objectif d'Aditxt d'accélérer les innovations dans le secteur de la santé. La collaboration pourrait également déboucher sur de futurs tests, tels que la détection précoce du cancer de l'ovaire.
Aditxt, Inc. (NASDAQ: ADTX) hat bekannt gegeben, dass ihre Tochtergesellschaft Pearsanta eine Kooperationsvereinbarung mit Evofem Biosciences für die Markteinführung eines blutbasierten Diagnosetests für Endometriose in den USA im Jahr 2025 eingegangen ist. Der Mitomic® Endometriosis Test (MET™) erkennt eine spezifische Deletion in der mitochondrialen DNA, einen neuartigen Biomarker für Endometriose.
Endometriose betrifft schätzungsweise 190 Millionen Frauen weltweit, wobei derzeit keine validierten blutbasierten Tests verfügbar sind. Die Zusammenarbeit hat zum Ziel, eine Markteinführungsstrategie und einen Geschäftsplan für den MET zu entwickeln. Über 300 Endometriose-Fälle wurden mit dem MET bewertet, und 600 sind für die klinische Validierung geplant.
Diese Partnerschaft entspricht der Strategie von Evofem, das Produktangebot für Frauengesundheit zu erweitern, sowie dem Ziel von Aditxt, Innovationen im Gesundheitswesen zu beschleunigen. Die Zusammenarbeit könnte auch zu zukünftigen Tests führen, wie z.B. der frühzeitigen Erkennung von Eierstockkrebs.
- Collaboration with Evofem Biosciences for targeted U.S. launch of endometriosis diagnostic in mid-2025
- MET aims to be the first validated blood-based biomarker test for endometriosis
- Over 300 endometriosis cases evaluated using MET, with 600 planned for clinical validation
- Potential for expansion into other diagnostic tests, such as early detection of ovarian cancer
- Launch of the diagnostic test is not expected until mid-2025, indicating a long wait for potential revenue generation
- Clinical validation of the test is still ongoing, with results not yet finalized
Insights
Pearsanta's Mitomic® Endometriosis Test (MET™) represents a significant breakthrough in endometriosis diagnostics. The test's focus on a specific deletion in mitochondrial DNA as a biomarker is innovative and could potentially revolutionize early detection. With
This collaboration between Pearsanta and Evofem Biosciences is a significant step forward in addressing the critical need for non-invasive endometriosis diagnostics. With approximately 190 million women worldwide affected by endometriosis, the potential impact of an accurate blood-based test is enormous. Early diagnosis is important for managing symptoms and potentially slowing disease progression. The MET™ could significantly reduce the current delay in diagnosis, which often takes years. However, it's important to temper expectations; while promising, the test still needs to complete clinical validation. The partnership with Evofem, given their established presence in women's health, could provide valuable market insights and distribution channels. This collaboration also aligns with the broader trend of comprehensive women's health solutions, potentially leading to improved care across various reproductive health issues.
The collaboration between Pearsanta and Evofem Biosciences presents a compelling market opportunity. The global endometriosis market is projected to reach
Endometriosis Affects Approximately 190 Million Women Worldwide
Non-invasive MET™ Diagnostic Test for Endometriosis Leverages Novel Biomarker: A Specific Deletion in Mitochondrial DNA
Pearsanta’s MET is Seeking to Become the First and Only Validated and Commercialized Blood-based Biomarker Test for Endometriosis
Endometriosis is a chronic disease associated with severe, life-impacting pain. It affects approximately one in ten women of reproductive age around the world – approximately 190 million women and girls - according to the World Health Organization.1
Pearsanta’s Mitomic® Endometriosis Test (“MET™”) looks for a specific deletion in mitochondrial DNA (“mtDNA”), which is a novel, proprietary biomarker for endometriosis. There are currently no validated blood-based tests for endometriosis available in
Under the Agreement, Evofem and Pearsanta will collaboratively develop a comprehensive go-to-market strategy and MET commercial plan ahead of the planned
This collaboration supports Evofem’s strategy to expand its commercial offering of innovative products that address key challenges in women’s health. The company currently commercializes a single-dose oral treatment for bacterial vaginosis and trichomoniasis and a hormone-free contraceptive vaginal gel. Its long-term goal is to deliver comprehensive healthcare solutions spanning prevention, diagnosis and treatment of sexual and reproductive health concerns facing women at every stage of life.
“We believe that Evofem's proven expertise and strategic focus on women’s health make them the ideal partner for the
Endometriosis has a profound impact on women's health, with significant implications beyond painful symptoms. Studies indicate that approximately
Early diagnosis of endometriosis is important to allow medical or surgical intervention to alleviate its symptoms and potentially slow or halt the natural progression of the disease. At present, there are no validated blood-based diagnostic tests for endometriosis1. Pearsanta aims to address this unmet need with its MET.
Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, said, “This partnership showcases the Aditxt platform in action, accelerating growth and transforming high-impact innovations into reality. By seeking to advance Pearsanta toward the commercialization of its Mitomic Endometriosis Test in 2025, while simultaneously supporting Evofem’s goals to expand its portfolio and diversify revenue streams through its existing infrastructure, we demonstrate how our platform seeks to drive progress for both current and incoming subsidiaries. We at Aditxt are proud to empower innovation and strive to help companies deliver transformative healthcare solutions to the market.”
“Knowledge is power and using Pearsanta’s Mitomic Endometriosis Test physicians will be able to diagnose and improve the lives of women who suffer from this debilitating chronic disease,” said Saundra Pelletier, CEO of Evofem Biosciences. “We look forward to leveraging our strong relationships with OB/GYNs and allied healthcare providers to plan and execute the successful
Beyond the MET, this collaboration has the potential to further expand Evofem’s women’s health business with future tests developed by Pearsanta, such as the Mitomic Ovarian Test for early detection of ovarian cancer.
About the Mitomic Technology Platform
Pearsanta’s proprietary Mitomic® Technology Platform harnesses the unique properties of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based liquid biopsies. This platform is designed to identify specific mutations in mtDNA indicative of various diseases. Due to its high mutation rate and continued persistence in cells, mtDNA has the potential to be an excellent biomarker for early disease detection. The program currently focuses on developing tests for early cancer detection (ovarian, prostate, and lung cancers), as well as non-cancerous conditions like endometriosis.
About Pearsanta, Inc.
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.
Mitomic® is a registered trademark and MET™ is a trademark of Pearsanta, Inc.
About Evofem Biosciences, Inc.
Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.
In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose.
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Phexxi® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.
About Aditxt, Inc.
Aditxt, Inc.® is an innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their 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. 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. 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.
For more information, www.aditxt.com.
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Sources
1World Health Organization fact sheet: Endometriosis. 24 March 2023. https://www.who.int/news-room/fact-sheets/detail/endometriosis.
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; 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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Aditxt, Inc.
Mary O’Brien
Mobrien@aditxt.com
516-753-9933
Source: Aditxt, Inc.
FAQ
What is the Mitomic Endometriosis Test (MET) developed by Aditxt's subsidiary Pearsanta?
When is Aditxt (ADTX) planning to launch the endometriosis diagnostic test in the U.S.?
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