PredicineCARE™ Liquid Biopsy Assay Featured in NEJM for PIK3CA-Mutated Breast Cancer Trial
Key Insights
PredicineCARE (search)™ liquid biopsy assay identified and enrolled patients with PIK3CA-mutated metastatic breast cancer (search) in a Phase III trial in China, as published in NEJM.
The PI3Kα inhibitor-based regimen doubled progression-free survival, showing consistent benefits across patient subgroups with the aid of PredicineCARE (search)™ biomarker testing.
PredicineCARE (search)™, a next-generation sequencing (NGS) assay, has received FDA breakthrough device designation and New York State approval, facilitating blood-based genomic alteration detection.
PredicineCARE (search)™, a next-generation sequencing (NGS) assay developed by Predicine (search), Inc., played a crucial role in identifying and enrolling patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer (search) (mBC) in a Phase III clinical trial conducted in China. The results of this trial have been published in The New England Journal of Medicine (NEJM).
The study demonstrated that a PI3Kα inhibitor-based regimen, guided by PredicineCARE (search)™ to identify patients with PIK3CA mutations, doubled progression-free survival compared to standard treatment. According to Dr. Huiping Li, Chair of the Department of Breast Oncology at Peking University Cancer Hospital & Institute, the new first-line standard of care offers significant hope for breast cancer (search) patients with PIK3CA mutations.
Clinical Utility of PredicineCARE™
PredicineCARE (search)™ is designed for blood-based testing to detect genomic alterations among trial participants. It has received both FDA breakthrough device designation and New York State approval. This assay exemplifies Predicine (search)'s commitment to providing robust, efficient, and cost-effective early biomarker testing, which helps identify patients who may benefit from targeted therapy, according to Dr. Shidong Jia, Founder & CEO of Predicine.
About the Study
The study focused on patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer (search) harboring PIK3CA mutations. These patients often face limited treatment options, and the identification of PIK3CA mutations is critical for selecting appropriate targeted therapies. The trial's success underscores the importance of liquid biopsy assays like PredicineCARE (search)™ in advancing precision medicine and improving patient outcomes.
Predicine (search) continues to develop 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. Predicine's portfolio includes blood, urine, and tissue-based NGS assays designed for globally harmonized use in clinical trials, companion diagnostic (CDx) development, and commercialization.