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SOPHiA GENETICS and Precision for Medicine Unveil Validated Novel Clinical Trial Assay at World Clinical Biomarkers & CDx 2024

NextEdge Admin

06 Sep 2024

2 min 40 sec

data-driven medicine,biopharma,clinical trials

SOPHiA GENETICS , a cloud-native leader in data-driven medicine, announced an update on its partnership with biopharma company Boundless Bio. Since 2022, the companies have been collaborating to develop and deploy Boundless Bio's extrachromosomal DNA (ecDNA) detection algorithm as a clinical trial device on the SOPHiA DDM™ Platform. This solution aims to identify patients with ecDNA-amplified tumors for Boundless Bio’s POTENTIATE Phase 1/2 clinical trial. Precision for Medicine, a precision medicine-focused CRO, provided critical laboratory services, successfully validating the proprietary workflow to process patient samples for the trial.

Oncogene amplification, particularly on ecDNA, contributes to malignant cellular growth in over 14% of cancer patients. Unlike chromosomal oncogene amplification, ecDNA is cancer-specific, making it a novel target for therapeutic intervention. Boundless Bio’s lead therapy, BBI-355, is the first treatment targeting ecDNA amplification.

SOPHiA GENETICS and Boundless Bio have pioneered the ecDNA Solution (ECS) algorithm to detect ecDNA using routine next-generation sequencing (NGS) data. This FDA-compliant Investigational Use Only Clinical Trial Assay (IUO CTA) is supporting patient selection in Boundless Bio’s ongoing clinical trials.

Peter Krein, Ph.D., Senior VP of Precision Medicine at Boundless Bio, emphasized the importance of SOPHiA GENETICS’ role in enabling the trial. Philippe Menu, M.D., Ph.D., Chief Medical Officer at SOPHiA GENETICS, expressed excitement about the collaboration’s potential to improve outcomes for patients with ecDNA-driven cancers.

Precision for Medicine adapted its diagnostic workflow to integrate seamlessly with the SOPHiA DDM™ Platform, enhancing the trial’s patient selection process and accelerating the development of new ecDNA-targeted therapies. Further insights into this collaboration shared at the World Clinical Biomarkers & CDx event in Boston on September 5, 2024.