PIK3CA

PredicineCARE™ enabled identification and enrollment of PIK3CA-mutated metastatic breast cancer patients in China, as published in The New England Journal of Medicine. The study demonstrated a doubling of progression-free survival with PI3Kα inhibitor-based regimens, supported by PredicineCARE™'s liquid biopsy assay.

Caris Life Sciences announces FDA approval of MI Cancer Seek, the first simultaneous Whole Exome and Whole Transcriptome Sequencing-based assay with CDx indications for molecular profiling of solid tumors, available for adults and pediatric patients.

PredicineCARE™ enabled identification and enrollment of PIK3CA-mutated metastatic breast cancer patients in China, leading to a doubling of progression-free survival with a PI3Kα inhibitor-based regimen, as published in The New England Journal of Medicine.

Predicine's PredicineCARE™ liquid biopsy assay, published in NEJM, identifies PIK3CA-positive patients in China, showing a doubling of progression-free survival in PIK3CA-mutated breast cancer patients.

FDA approves MI Cancer Seek as companion diagnostic for cancer patients aged 1-22, offering comprehensive molecular profiling via whole-exome and whole-transcriptome sequencing. The diagnostic includes indications for breast, colorectal, melanoma, non-small cell lung, endometrial, and solid tumors, aiding in targeted therapy decisions.

PredicineCARE™ enabled accurate identification of PIK3CA-mutated metastatic breast cancer patients in China, contributing to FDA approval of Inavolisib in the U.S.

FY 2025 appropriations negotiations are on hold due to the general election; NIH funding remains a focus for the medical research community. The FDA's Oncologic Drugs Advisory Committee discussed PD-L1 expression as a biomarker for anti-PD-1 therapies, potentially leading to changes in drug labeling. An FDA-AACR workshop on DPD deficiency testing before chemotherapy with fluoropyrimidines is scheduled for January 16, 2025. Representatives Wasserman Schultz and DeGette urged the FDA to finalize e-cigarette PMTA reviews. The FDA approved five oncology drugs and new indications between September 21 and October 25, 2024.