Study Confirms Regulatory-Grade Performance and AI-Driven Clinical Utility to Advance Precision Oncology and Patient Stratification for Drug Development

BostonGene, a leader in AI-powered solutions for drug discovery and development, today announced the publication of a pivotal study, “Clinical and analytical validation of a combined RNA and DNA exome assay across a large tumor cohort,” in Communications Medicine, a high-impact journal in the Nature portfolio. The study underscores the BostonGene Tumor Portrait™ assay as a clinically robust, regulatory-grade platform that forms the foundation of BostonGene’s AI-powered platform, purpose-built for precision oncology and designed to accelerate therapeutic development and enhance clinical data collection.

The Tumor Portrait™ assay integrates DNA and RNA sequencing into a single end-to-end test, delivering a multimodal view of each tumor. Approved under CLIA, CAP and the New York State Department of Health, the platform enhances patient stratification, predictive biomarker discovery and clinical trial enrollment—all critical to reducing the risks associated with drug development and improving clinical trial success rates.

The study details the implementation of highly stable clinical RNA-seq protocol, deployed in ready-to-use clinical settings and tested across more than 2,200 tumors, demonstrating high reproducibility, strong clinical actionability (98% of cases) and advanced detection of alterations, fusions, immune signatures, tumor microenvironment profiles and AI-based predictive classifications.

“Delivering clinically validated multimodal data from a single tumor sample—and interpreting it through an immune-focused, AI-enabled lens—represents a transformative advancement for oncology drug development,” said Alexander Bagaev, PhD, Chief Product Officer at BostonGene. “By combining DNA and RNA sequencing in one assay, our platform enables deeper biological understanding of the tumor microenvironment and genetics, smarter patient selection and more confident, data-driven decisions throughout the drug development lifecycle. This validation sets a new benchmark for translational research and diagnostic innovation.”

About BostonGene Corporation

BostonGene helps drug developers de-risk and accelerate research and development using a clinically validated AI platform purpose-built for oncology and supported by a CLIA-certified and CAP-accredited clinical laboratory. By integrating advanced molecular and immune profiling with clinical data, we uncover actionable insights that inform trial design, optimize patient selection and improve clinical outcomes. Our diagnostic and treatment recommendation solutions are used in clinical settings to personalize care and guide therapy decisions for patients. For more information, visit www.BostonGene.com.

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“Delivering clinically validated multimodal data from a single tumor sample—and interpreting it through an immune-focused, AI-enabled lens—represents a transformative advancement for oncology drug development.”