Pipeline
Cancer Detection
Overview
YD Biopharma’s Cancer Detection Services and investigational products leverage advanced DNA methylation analysis and blood-based testing technologies. Through strategic collaborations, including an exclusive partnership with EG BioMed, we are developing solutions intended to provide accurate, non-invasive approaches for the early detection of life-threatening cancers. Focusing on scientific precision and innovation, we are committed to advancing the field of cancer diagnostics and contributing to the improvement of patient care outcomes.
Disclaimer
The Cancer Detection Services and Products described herein are investigational and are currently under research and development. They have not been approved for clinical or commercial use by regulatory authorities in any jurisdiction.
Product
EG Pancreatic Blood Test Kit
EG Breast Blood Test Kit
Regulatory Strategy Development
Pre-Submission Preparation
Regulatory Submission & FDA Review
Approval & Market Launch
EG Pancreatic Blood Test Kit
Regulatory Strategy & FDA Engagement
A pre-submission meeting with the FDA is targeted for Q4 2025.
EG BioMed is actively preparing the pancreatic cancer blood test for future regulatory submission and is evaluating potential expedited pathways, including:
Breakthrough Devices Program:
An FDA program intended to expedite the development and review of innovative medical devices for life-threatening or irreversibly debilitating conditions, offering prioritized guidance and collaborative feedback.
Safer Technologies Program (SteP):
An FDA initiative providing an expedited process for devices that aim to significantly improve safety for non-life-threatening conditions, while maintaining stringent safety and effectiveness standards.
Next Steps
Following the evaluation, EG BioMed plans to formally request a pre-submission meeting with the FDA to discuss the regulatory pathway and clinical trial design considerations.
EG Breast Blood Test Kit
Regulatory Progress
July 11, 2024: EG BioMed submitted a De Novo classification request to the FDA for its breast cancer monitoring blood test, seeking designation as a Class II medical device.
September 24, 2024: The FDA issued a decision letter outlining specific items requiring further clarification within 180 days. EG BioMed is currently reviewing the feedback and preparing a response.
January 8, 2025: EG BioMed submitted a Q-Submission to the FDA, requesting feedback on proposed clinical trials and analytical validation studies.
February 29, 2025: The FDA scheduled a teleconference with EG BioMed to discuss the Q-Submission topics.
Laboratory Development & Certification
EG BioMed has contracted an independent laboratory in Washington State to develop its breast cancer blood test as a Laboratory Developed Test (LDT).
The laboratory obtained certification for the Laboratory Developed Test (LDT) platform.
