Predicine's PredicineCARE™ liquid biopsy assay has been highlighted in The New England Journal of Medicine for its role in patient enrollment in a Phase III breast cancer trial. The assay enabled the identification and enrollment of patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) in China.
The study's findings indicate a significant improvement in patient outcomes through the use of targeted therapy based on biomarker testing. According to Dr. Huiping Li, Chair of the Department of Breast Oncology at Peking University Cancer Hospital & Institute, the PI3Kα inhibitor-based regimen doubled the progression-free survival with consistent benefit across all pre-specified patient subgroups. "With the essential support of biomarker testing, this new first-line standard of care brings significant hope to breast cancer patients with PIK3CA mutations," Dr. Li stated.
Assay Details and Clinical Utility
PredicineCARE™ is a next-generation sequencing (NGS) assay designed for blood-based testing to detect genomic alterations. It has received both FDA breakthrough device designation and New York State approval, underscoring its clinical utility in identifying patients who may benefit from targeted therapy.
Predicine's Commitment to Precision Medicine
Dr. Shidong Jia, Founder & CEO of Predicine, emphasized the company's commitment to advancing precision medicine in oncology. "The publication in The New England Journal of Medicine demonstrates the clinical utility of PredicineCARE™ liquid biopsy assay in global clinical trials and personalized cancer care, exemplifying our commitment to robust, efficient, and cost-effective early biomarker testing," said Dr. Jia.
Predicine is focused on developing 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 company's portfolio includes blood, urine, and tissue-based NGS assays designed for global use in clinical trials, companion diagnostic (CDx) development, and commercialization.
