PredicineCARE Liquid Biopsy Assay Featured in NEJM as Pivotal Tool in Roche’s Phase III Itovebi Breast Cancer Trial 

PredicineCARE was utilized to identify and enroll patients with PIK3CA-mutated metastatic breast cancer in China, a key component contributing to the FDA’s approval of Inavolisib in the U.S. on October 10, 2024.

HAYWARD, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) — Predicine, Inc., a pioneer in the field of liquid biopsy, is pleased to announce the publication of a landmark study in The New England Journal of Medicine (NEJM). This study highlights the clinical utility of the PredicineCARE liquid biopsy assay in Roche’s pivotal INAVO120 Phase 3 clinical trial of Inavolisib (Itovebi), which targets patients with PIK3CA-mutated, hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer (mBC).  

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.   

“Itovebi-based regimen demonstrated a doubling of the progression-free survival with consistent benefit across all pre-specified patient subgroups,” said Dr Huiping Li, Chair of Department of Breast Oncology at Peking University Cancer Hospital & Institute, and one of the principal investigators of the INAVO120 study. “With the essential support of biomarker testing, this new first-line standard of care brings significant hope to breast cancer patients with PIK3CA mutations.”  

PredicineCARE, a next-generation sequencing (NGS) assay, facilitated accurate blood ctDNA-based testing to detect genomic alterations among trial participants. This publication emphasizes Predicine’s commitment to providing 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.  

“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. “With a remarkable 98.7% testing success rate and a rapid turnaround time (TAT) of just five business days in this study, PredicineCARE exemplified our commitment to robust, efficient and cost-effective early biomarker testing, helping identify patients who may benefit from targeted therapy such as Itovebi.” 

About Predicine  

Predicine is a global molecular insights company committed to advancing precision medicine in oncology and infectious disease diagnostics. Predicine is developing 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. The Predicine portfolio includes blood, urine, and tissue based NGS assays designed for globally harmonized use in clinical trial, companion diagnostic (CDx) development, and commercialization. Through its business operations in Silicon Valley, Houston, Chicago and Shanghai, Predicine is partnering and collaborating with leading biopharma companies, institutions, and governments to support personalized healthcare on a global scale. Further information is available on the company websites, http://www.predicine.com. Stay in touch on LinkedIn or @Predicine on Twitter. 

Contact Information: 
Predicine, Inc. 
media@predicine.com 

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