Predicine's PredicineCARE™ liquid biopsy assay played a crucial role in identifying and enrolling patients with PIK3CA-mutated metastatic breast cancer in China for a Phase III trial. The findings were published in The New England Journal of Medicine (NEJM), underscoring the assay's clinical utility.
The trial focused on patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (mBC). According to Dr. Huiping Li, Chair of Department of Breast Oncology at Peking University Cancer Hospital & Institute, the PI3Kα inhibitor-based regimen doubled progression-free survival with consistent benefit across all pre-specified patient subgroups. She added that biomarker testing provides significant hope to breast cancer patients with PIK3CA mutations, establishing a new first-line standard of care.
PredicineCARE™ Assay Details
PredicineCARE™ is a next-generation sequencing (NGS) assay that uses blood-based testing to detect genomic alterations among trial participants. The assay has received both FDA breakthrough device designation and New York State approval.
Company Perspective
Dr. Shidong Jia, Founder & CEO of Predicine, stated that the NEJM publication demonstrates the clinical utility of PredicineCARE™ liquid biopsy assay in global clinical trials and personalized cancer care. He emphasized the company's commitment to robust, efficient, and cost-effective early biomarker testing to identify patients who may benefit from targeted therapy.
About Predicine
Predicine is a global molecular insights company focused on advancing precision medicine in oncology and infectious disease diagnostics. The company develops 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. 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. The company partners with biopharma companies, institutions, and governments to support personalized healthcare on a global scale.
