Ludwig Enterprises announced the publication of an abstract at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting detailing a breakthrough non-invasive screening test for breast cancer. The research combines messenger RNA (mRNA) analysis from buccal cheek cells with machine learning algorithms to detect breast cancer signals, potentially offering a less invasive alternative to current screening methods.
The study, titled "Non-invasively-collected buccal cell mRNA reveals novel breast cancer signal," addresses the need for improved screening approaches for breast cancer, which remains the most frequently diagnosed cancer globally. While DNA genetic testing is widely used, mRNA analysis can provide complementary diagnostic insights, particularly concerning inflammatory pathways linked to cancer development.
Novel Methodology and Study Design
The research team collected buccal cheek swab samples non-invasively from breast cancer patients and controls across 40 U.S. clinical centers. A custom microarray chip was developed to analyze 48 mRNA-based cytokine biomarkers, specifically selected for their association with inflammatory pathways and cancer development.
Next-generation sequencing was performed using Thermo Fisher Genestudio S-5 following cDNA target amplification. The researchers then used these data to train a linear support vector machine to classify subjects with respect to their cancer status, with particular focus on identifying a small subset of biomarkers that could yield significant results for a lower-dimensional, efficient classification approach.
Promising Performance Results
The analysis identified multiple six-biomarker combinations yielding excellent results with F-scores ≥0.85. Two top-performing biomarker systems demonstrated particularly strong performance metrics:
System 1 incorporated biomarkers CASP9, IL1B, IL6, RGS2, SLC40A1, and STK11, achieving precision of 0.892, recall of 0.913, F1-score of 0.9, and AUC of 0.897.
System 2 utilized biomarkers HAMP, IL10, RGS2, SLC22A4, STK11, and TGFB1, demonstrating precision of 0.888, recall of 0.902, F1-score of 0.892, and AUC of 0.849.
Clinical Implications and Future Potential
"Ludwig Enterprises is pleased to now share these encouraging findings with the broader scientific community and the public, following the lifting of the ASCO embargo," said Marvin S. Hausman, MD, Chief Science Officer at Ludwig Enterprises. "This research represents a potential step forward in developing less invasive screening options that could aid in the earlier detection of breast cancer."
The study underscores that intercellular mRNA communication is a key characteristic of chronic inflammation associated with cancer development. The high precision and recall values suggest potential clinical utility for early detection, offering a non-invasive alternative that could complement existing screening protocols.
Company Background
Ludwig Enterprises, Inc., which is in the process of changing its name to Revealia Diagnostics, Inc., operates as a biotech and healthcare holding company focused on mRNA genomics and machine learning AI technology. The company's mission centers on identifying, monitoring, and creating solutions to mitigate chronic inflammation, which they identify as the causative agent of illnesses such as cancer and heart disease responsible for more than 50% of deaths worldwide.
