PredicineCARE, a liquid biopsy assay developed by Predicine, Inc., has been highlighted in a New England Journal of Medicine (NEJM) publication for its role in Roche's pivotal INAVO120 Phase 3 clinical trial. The assay was instrumental in identifying and enrolling patients with PIK3CA-mutated, hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer (mBC) in China, contributing to the FDA's approval of Inavolisib (Itovebi) in the U.S. on October 10, 2024.
The U.S. FDA recently approved the Itovebi-based regimen as a first-line treatment for people with HR+, Her2-negative breast cancer with PIK3CA mutations. The PredicineCARE blood ctDNA assay played an instrumental role by enabling the accurate identification and enrollment of PIK3CA-positive mBC patients in China.
Clinical Impact of INAVO120 Trial
The INAVO120 trial evaluated the efficacy of the Itovebi-based regimen in patients with PIK3CA-mutated mBC. According to Dr. Huiping Li, Chair of Department of Breast Oncology at Peking University Cancer Hospital & Institute, the Itovebi-based regimen demonstrated a doubling of 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," said Dr. Li.
PredicineCARE Assay Details
PredicineCARE is a next-generation sequencing (NGS) assay that facilitates accurate blood ctDNA-based testing to detect genomic alterations among trial participants. The assay achieved a 98.7% testing success rate with a rapid turnaround time (TAT) of just five business days in the INAVO120 study. This performance underscores Predicine's commitment to robust, efficient, and cost-effective early biomarker testing, helping identify patients who may benefit from targeted therapy such as Itovebi.
Predicine's Mission
"The publication of the INAVO120 study in the New England Journal of Medicine demonstrates the clinical utility of harmonized PredicineCARE liquid biopsy assay in global clinical trials and personalized cancer care," said Dr. Shidong Jia, Founder & CEO of Predicine. Predicine aims to provide accurate, accessible, and affordable (AAA) liquid biopsy solutions to support global clinical trials, companion diagnostics (CDx) development, and commercialization. PredicineCARE has received both FDA breakthrough device designation and New York State approval.
