Predicine Announces New Study Published in The New England Journal of Medicine Demonstrating Clinical Utility of its MRD Liquid Biopsy Assay in Supporting Genentech's Phase 1 Clinical Trial of Divarasib
HAYWARD, Calif., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Predicine, Inc., a pioneer in the field of liquid biopsy, announced a new study published in The New England Journal of Medicine (NEJM), demonstrating the clinical utility of its minimal residual disease (MRD) Liquid Biopsy Assay in support of Genentech's Phase 1 Clinical Trial of Divarasib. This milestone reaffirms Predicine's position as a leader in the field of liquid biopsy diagnostics.
In this global Phase 1 clinical trial of Divarasib, Predicine’s tumor-naïve, blood-informed MRD solution, PredicineBEACON™, played a central role in assessing the safety and efficacy of the treatment. The trial results were nothing short of remarkable, with confirmed response rates observed in patients with non-small cell lung cancer (NSCLC) (56%), colorectal cancer (CRC) (36%), and other solid tumors (36%) at the highest dose.
What sets this biomarker study apart is the blood-informed circulating tumor DNA (ctDNA) profiling at the ultra-deep MRD level using Predicine's proprietary liquid biopsy next-generation sequencing (NGS) platform. PredicineBEACON™, a tumor naïve, personalized minimal residual disease (MRD) assay, enabled precise monitoring of genomic alterations and emerging resistance mechanisms.
The longitudinal assessment of circulating tumor DNA at the MRD level (100,000X sequencing depth) revealed declines in KRAS G12C variant allele frequency, strongly associated with positive treatment response. Additionally, this analysis identified genomic alterations that may contribute to resistance to Divarasib. Remarkably, a reduction in KRAS G12C variant allele frequency was observed as early as day 15 of cycle 1. Importantly, the study highlights the correlationbetween the molecular dynamics of KRAS G12C mutation and complete or partial responses to Divarasib across all three tumor types (NSCLC, CRC, and other solid tumors). These findings underscore the clinical utility of liquid biopsy profiling in the assessment of phase I clinical trial of Divarasib.
“As a physician, I'm constantly searching for tools that can provide deeper insights into our patients' conditions. Liquid biopsy has been a game-changer in our approach to cancer care. It offers a minimally invasive yet highly informative window into the molecular landscape of tumors. It's transforming how we understand and treat solid tumors. Liquid biopsy holds tremendous promise for patients,” said Dr. Jayesh Desai from Peter McCullum Cancer Center, who is the corresponding author of this study.
"We are delighted to witness the significant clinical impact of Predicine's blood-informed MRD liquid biopsy solutions in the context of Genentech's Phase 1 clinical trial of Divarasib,” said Dr. Shidong Jia, Founder & CEO of Predicine. “This milestone publication with Divarasib is a testament to the power of Predicine's unique liquid biopsy technology to advance precision oncology and clinical trials.”
The publication can be found online at: Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation - PubMed (nih.gov)
Predicine is a global molecular insights company committed to advancing precision medicine in oncology and infectious disease diagnostics. Predicine is developing proprietary technologies for cell-free DNA and cell-free RNA liquid biopsy to enable minimally invasive molecular diagnoses for early cancer detection, treatment selection, therapy response, minimal residual disease monitoring, and disease progression. The Predicine portfolio includes blood, urine, and tissue based NGS assays designed for globally harmonized use in research, clinical investigation, and companion diagnostic (CDx) development. Through its business operations in Silicon Valley, Houston, Chicago, Shanghai, Beijing, Suzhou, and Harbin, Predicine is partnering and collaborating with leading biopharma companies, institutions, and governments to support personalized healthcare on a global scale. Further information is available on the company websites, http://www.predicine.com. Stay in touch on LinkedIn or @Predicine on Twitter.