Aditxt Subsidiary Pearsanta Submits a Grant Application Seeking to Advance Clinical Trials for Mitomic Prostate Test, Targeting Early Detection in High-Risk Patients
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 grant application to the Prostate Cancer Research Program (PCRP) under the Department of Defense (DoD) Implementation Science Award funding mechanism seeking $2 million in funding. This non-dilutive funding initiative aims to advance the early detection and management of prostate cancer, a disease that remains one of the most prevalent and challenging cancers affecting men globally.
The MPT, a blood test detecting a specific 3.4 kb mitochondrial DNA deletion, has shown robust diagnostic performance for clinically significant prostate cancer. The proposed study aims to first validate the MPT in its CLIA/CAP facility in Virginia. Once the validation is completed, the Science Award, if granted, would be expected to provide Pearsanta with sufficient funds to evaluate the test in a randomized clinical trial (RCT) to determine its effectiveness in better identifying men with PSA levels in the gray zone who would have clinically significant prostate cancer and potentially reducing unnecessary biopsies. Up to 1,000 men at risk for prostate cancer based on PSA levels 2-10 ng/mL will be randomized to “MPT-informed care” or standard of care and followed for one year to determine the number and results of any performed biopsies.
Prostate cancer is a significant health concern worldwide, according to the World Health Organization (WHO), with an estimated 1.5 million new cases diagnosed globally in 2024, making it the second most common cancer among men and the fourth most common cancer overall. In the United States alone, approximately 299,010 new cases and around 35,250 deaths are expected this year, according to the American Cancer Society. The lifetime risk for a man being diagnosed with prostate cancer is about 1 in 8, while the risk of dying from it is approximately 1 in 44.
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, mtDNA has the potential to be an excellent biomarker for early disease detection. Currently, the program focuses on developing tests for early cancer detection, ovarian, prostate, and lung cancers, and addressing non-cancerous conditions like endometriosis.