• Ovarian Cancer Diagnostic Market Growth: Projected Increase from $1.5 Billion in 2023 to $2.7 Billion by 2032¹ Amidst Current Challenges of Insufficiently Sensitive Blood Tests for Early Detection

MOUNTAIN VIEW, Calif. / Aug 07, 2024 / Business Wire / Aditxt, Inc. ("Aditxt") (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, announced that its subsidiary, Pearsanta, Inc. (“Pearsanta”) has submitted a proposal for the Clinical Trial Translational Endpoints Research Award to the Congressionally Directed Medical Research Programs (CDMRP) of the Department of Defense. The proposal aims to validate a novel assay based on Pearsanta’s proprietary Mitomic® Technology for the early detection of ovarian cancer.

According to the World Ovarian Cancer Coalition, ovarian cancer remains a significant health concern, with over 324,603 new cases diagnosed worldwide in 2022. It is the 18th most common cancer globally and the 8th most common among women, according to the World Cancer Research Fund International. The lifetime risk for a woman being diagnosed with ovarian cancer is approximately 1 in 87, while the risk of dying from invasive ovarian cancer is about 1 in 130, based on information provided by the American Cancer Society. According to the Ovarian Cancer Research Alliance, the five-year relative survival rate for ovarian cancer stands at around 50.8%. Despite the prevalence of this cancer, Pearsanta does not believe that any blood tests are currently available with adequate sensitivity for early detection of ovarian cancer, underscoring a critical need for improved diagnostic methods​.

Pearsanta’s Mitomic Technology Platform seeks to harness 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 cell persistence, Pearsanta believes mtDNA is an excellent biomarker for early disease detection. This platform allows for the rapid and accurate identification of disease-associated biomarkers, significantly enhancing early diagnosis and treatment. Currently, the program focuses on developing tests for early cancer detection, targeting ovarian, prostate, and lung cancers, and addressing non-cancerous conditions like endometriosis.

Pearsanta’s proposal to CDMRP focuses on validating the Mitomic Ovarian Test (MOT), which utilizes mtDNA mutations as early indicators of ovarian cancer. The application of mtDNA technology to detect ovarian cancer in servicewomen could potentially also transition to US public health funding agencies such as BARDA, showcasing the significant potential for widespread public health utilization. The objective is to create a reliable blood test that can detect ovarian cancer at its earliest stages, which has the potential to improve treatment outcomes and survival rates significantly. In response to the CDMRP’s Clinical Trial Translational Endpoints Research Award, the Pearsanta team has designed a prospective cohort study collecting blood samples and clinical information from patients undergoing surgery to diagnose ovarian cancer. Follow-up surgical reports identify the tumor’s presence, type, and stage. The study will enroll 100 subjects with ovarian cancer and 200 negative controls. The control group will include both symptomatic patients with no detected cancer and asymptomatic patients, some of whom have a history of other gynecologic cancers, breast cancer, or endometriosis. The study is powered to detect significant diagnostic accuracy (AUC > 0.85) at each stage of epithelial ovarian cancer vs. controls and non-epithelial cancer vs. controls.

This proposal aims to validate one or more mtDNA deletions as a test for early ovarian cancer detection. It is hypothesized that the MOT will display acceptable diagnostic performance in detecting all four stages of ovarian cancer, with an AUC greater than 0.85.

Chris Mitton, President of Pearsanta, stated, “Submitting this proposal to the CDMRP is another step in our mission to revolutionize early cancer detection. Our proprietary Mitomic Technology aims to provide a reliable, non-invasive, and effective blood test that can lead to earlier detection, more effective treatments, and, ultimately, save lives. This innovation has the potential to dramatically improve outcomes for many women, significantly reducing the mortality rate associated with ovarian cancer. We are focused on validating the MOT for clinical use and supporting its launch as a Laboratory Developed Test (LDT), fundamentally transforming ovarian cancer diagnosis and treatment.”

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, added, “We believe the clinical impact of Pearsanta’s Mitomic Ovarian Test could be profound. If we are successful in facilitating earlier detection and more effective treatment interventions through a simple blood test, we believe that we can significantly improve survival rates for women with ovarian cancer, addressing a critical unmet need in women's health. Despite the high incidence and mortality rates, we are not aware that any blood tests are currently available with adequate sensitivity for early ovarian cancer detection. Our acceleration of Pearsanta’s innovations seeks to address a critical unmet need in women's health and can potentially save many lives.”

Aditxt currently operates two programs focused on immune health and precision health. Following the completion of the Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) and Evofem Biosciences, Inc. (OTCQB: EVFM) transactions, Aditxt will introduce two additional programs dedicated to public health and women's health. Each program is 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 these transactions 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.

About Aditxt, Inc.

Aditxt, Inc.^® is an innovation platform dedicated to discovering, developing, and deploying promising 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 has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing national and population health and impacting public health globally. Pearsanta™, Inc., delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, led by its CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA.

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About Pearsanta, Inc.

Pearsanta is a commercial-stage company dedicated to revolutionizing precision diagnostics through advanced technologies. Leveraging its proprietary Mitomic® Technology Platform, Pearsanta focuses on early disease detection, significantly improving patient outcomes. The company’s diagnostic portfolio includes tests for ovarian and prostate cancers and endometriosis. By identifying specific mitochondrial DNA (mtDNA) mutations, Pearsanta’s non-invasive, blood-based liquid biopsies provide rapid and accurate disease detection. Committed to enhancing lifelong well-being, Pearsanta addresses critical healthcare needs with innovative solutions that empower individuals to achieve optimal health.

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¹ https://www.gminsights.com/industry-analysis/ovarian-cancer-diagnostic-market/market-size