Pipeline
Cancer Detection Products
Overview
YD Biopharma’s Cancer Detection Service and Products harness the power of cutting-edge DNA methylation analysisand advanced blood testing technologies. Through strategic partnerships, including an exclusive collaboration with EG BioMed, our solutions are designed to provide accurate, non-invasive, and early detection for life-threatening cancers. With a focus on precision and innovation, we aim to revolutionize cancer diagnostics and improve patient outcomes worldwide.
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
The pre-submission meeting with the FDA is targeted for Q4 2025.
EG BioMed is actively preparing its pancreatic cancer blood test for regulatory submission and evaluating expedited approval pathways, including:
Breakthrough Devices Program:
Accelerates the development and review of innovative medical devices for life-threatening or irreversibly debilitating conditions by offering prioritized guidance, faster review timelines, and collaborative FDA feedback.
Safer Technologies Program (SteP):
Provides an expedited pathway for devices that significantly improve safety for non-life-threatening conditions, ensuring efficient regulatory approval while maintaining rigorous safety and efficacy standards.
Next Steps
Following its evaluation, EG BioMed plans to formally request a pre-submission meeting with the FDA to discuss the regulatory pathway and clinical trial design.
EG Breast Blood Test Kit
Regulatory Progress
July 11, 2024: EG BioMed submitted a de novo application to the FDA for its breast cancer monitoring blood test as a Class II medical device.
September 24, 2024: The FDA issued a decision letter, outlining specific points that must be addressed within 180 days. EG BioMed has not yet responded to the letter.
January 8, 2025: EG BioMed submitted a Q-Submission to the FDA, requesting feedback on clinical trials and analytical studies related to the test.
February 29, 2025: The FDA scheduled a teleconference with EG BioMed to discuss the Q-Submission.
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 aims to obtain certification for this technology by March 2025.
