Aditxt Subsidiary Pearsanta Seeks Clinical Trial Translational Endpoints Research Award for Early Detection of Ovarian Cancer

Rhea-AI Summary

Aditxt (NASDAQ: ADTX) announced that its subsidiary, Pearsanta, has submitted a proposal for the Clinical Trial Translational Endpoints Research Award to validate a novel assay for early detection of ovarian cancer. The proposal aims to validate the Mitomic Ovarian Test (MOT), which uses mitochondrial DNA mutations as early indicators of ovarian cancer. The study will enroll 100 subjects with ovarian cancer and 200 negative controls, aiming to detect significant diagnostic accuracy (AUC > 0.85) at each stage of epithelial ovarian cancer vs. controls.

The ovarian cancer diagnostic market is projected to grow from $1.5 billion in 2023 to $2.7 billion by 2032. Currently, no blood tests are available with adequate sensitivity for early ovarian cancer detection. If successful, Pearsanta's MOT could significantly improve survival rates for women with ovarian cancer through earlier detection and more effective treatment interventions.

Positive

• Pearsanta submitted a proposal for a Clinical Trial Translational Endpoints Research Award to validate its Mitomic Ovarian Test
• The ovarian cancer diagnostic market is projected to grow from $1.5 billion in 2023 to $2.7 billion by 2032
• The proposed study aims to detect significant diagnostic accuracy (AUC > 0.85) for ovarian cancer detection
• Pearsanta's Mitomic Technology Platform could potentially improve early cancer detection through non-invasive blood tests

Negative

• The closing of Aditxt's transactions with Appili Therapeutics and Evofem Biosciences is subject to several conditions, including shareholder approval and sufficient capital raising
• No assurance can be provided that all conditions for closing the transactions will be obtained or satisfied

Medical Research Analyst

Pearsanta's proposal for the Clinical Trial Translational Endpoints Research Award is a significant step towards addressing a critical gap in ovarian cancer diagnostics. The current lack of sensitive blood tests for early detection underscores the potential impact of their Mitomic Ovarian Test (MOT). With ovarian cancer being the 8th most common cancer among women globally, a successful early detection method could be transformative.

The study design, involving 100 subjects with ovarian cancer and 200 negative controls, appears robust. The target AUC of >0.85 for diagnostic accuracy is ambitious but achievable. If successful, this could lead to earlier interventions and potentially improve the current 50.8% five-year relative survival rate. However, it's important to note that while promising, the technology is still in the validation phase and regulatory approval will be a significant hurdle before clinical implementation.

Financial Analyst

The ovarian cancer diagnostic market's projected growth from $1.5 billion in 2023 to $2.7 billion by 2032 presents a substantial opportunity for Aditxt and its subsidiary Pearsanta. If the Mitomic Ovarian Test proves successful, it could capture a significant market share, potentially driving revenue growth for Aditxt.

However, investors should be cautious. The company is still in the research and development phase, with no guarantee of clinical or commercial success. The need for capital to fund the closing of Appili Therapeutics and Evofem Biosciences transactions adds financial risk. Aditxt's stock (NASDAQ: ADTX) may experience volatility as the market reacts to developments in this high-potential but uncertain venture.

Oncology Doctor

The potential of Pearsanta's Mitomic Technology to detect ovarian cancer early is exciting from a clinical perspective. Current diagnostic methods often detect ovarian cancer at later stages, contributing to poor outcomes. A blood test with high sensitivity could revolutionize our approach to ovarian cancer screening and management.

The focus on mitochondrial DNA (mtDNA) as a biomarker is innovative. mtDNA's high mutation rate and cell persistence make it a promising target for early detection. If successful, this could lead to earlier interventions and potentially improve the 1 in 130 risk of dying from invasive ovarian cancer. However, it's important to await clinical trial results and peer-reviewed validation before drawing definitive conclusions about the test's efficacy and clinical utility.

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.--(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.

For more information, www.aditxt.com.

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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.

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 on its strategic M&A initiatives; the Company’s ability 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 the Company’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.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20240807302870/en/

Media Relations Contact:

Mary O’ Brien

mobrien@aditxt.com

(516) 753-9933

Source: Aditxt, Inc.

FAQ

What is the purpose of Pearsanta's Mitomic Ovarian Test (MOT) for ADTX?

Pearsanta's Mitomic Ovarian Test (MOT) aims to provide early detection of ovarian cancer through a non-invasive blood test, potentially improving treatment outcomes and survival rates for women with ovarian cancer.

How many subjects will be enrolled in Pearsanta's ovarian cancer detection study for ADTX?

The study will enroll 100 subjects with ovarian cancer and 200 negative controls, including both symptomatic patients with no detected cancer and asymptomatic patients.

What is the projected growth of the ovarian cancer diagnostic market relevant to ADTX?

The ovarian cancer diagnostic market is projected to grow from $1.5 billion in 2023 to $2.7 billion by 2032, indicating significant potential for Aditxt's subsidiary Pearsanta and its Mitomic Ovarian Test.

What is the diagnostic accuracy target for Pearsanta's Mitomic Ovarian Test (MOT) for ADTX?

The study aims to detect significant diagnostic accuracy with an Area Under the Curve (AUC) greater than 0.85 at each stage of epithelial ovarian cancer versus controls.