PredicineCARE™ Liquid Biopsy Assay Featured in NEJM for Breast Cancer Trial Enrollment
核心洞察
PredicineCARE™ liquid biopsy assay enabled the identification and enrollment of PIK3CA-positive patients in a Phase III breast cancer (搜索) trial in China.
The PI3Kα inhibitor (搜索)-based regimen demonstrated a doubling of progression-free survival, offering significant hope for breast cancer (搜索) patients with PIK3CA mutations.
PredicineCARE™ is a next-generation sequencing (NGS) assay that facilitates blood-based testing to detect genomic alterations and has received FDA breakthrough device designation and New York State approval.
Predicine (搜索)'s PredicineCARE™ liquid biopsy assay has been highlighted in The New England Journal of Medicine (NEJM) for its role in identifying and enrolling PIK3CA-positive patients in a Phase III breast cancer (搜索) trial conducted in China. The assay facilitated the selection of patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) for the trial.
Clinical Impact of PI3Kα Inhibition
The study demonstrated that the PI3Kα inhibitor (搜索)-based regimen led to a doubling of progression-free survival (PFS) in the selected patient population. Dr. Huiping Li, Chair of the Department of Breast Oncology at Peking University Cancer Hospital & Institute, emphasized the significance of biomarker testing in identifying patients who benefit from this new first-line standard of care.
PredicineCARE™ Assay Details
PredicineCARE™ is a next-generation sequencing (NGS) assay designed for blood-based detection of genomic alterations. It has received FDA breakthrough device designation and New York State approval, underscoring its potential clinical utility in personalized cancer care.
Company Perspective
Dr. Shidong Jia, Founder & CEO of Predicine (搜索), stated that the publication in NEJM demonstrates the assay's value in global clinical trials and personalized cancer care. He highlighted the company's commitment to providing robust, efficient, and cost-effective early biomarker testing to identify patients who may benefit from targeted therapy.
About Predicine
Predicine (搜索) is a global molecular insights company focused on advancing precision medicine in oncology and infectious disease diagnostics. The company develops 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 monitoring, minimal residual disease monitoring, and disease progression. Predicine offers blood, urine, and tissue-based NGS assays for clinical trials, companion diagnostic (CDx) development, and commercialization.