The research‑use‑only test for post‑treatment breast cancer monitoring is now available through the company’s affiliate EG Biomed US.
YD Bio announced expanded US access to OkaiDx, a research-use-only blood test that uses cfDNA methylation profiling for post-treatment breast cancer monitoring. The test is now available through affiliate EG Biomed US Inc’s CLIA/CAP-certified laboratory.
The cfDNA methylation-based assay was developed through international scientific collaboration and generates molecular surveillance information for research settings. YD Bio will support commercialization efforts under authorization granted to the company, working with EG BioMed to make the test accessible to research laboratories, academic groups, and industry partners conducting surveillance and translational studies.
“Independent validation already reported performance metrics of 95.1% accuracy, 89.4% sensitivity and 96.5% specificity,” says Dr Ethan Shen, founder, chairman and chief executive officer of YD Bio Limited, in a release.
The test has been reported in peer-reviewed journals, including Clinical Epigenetics and Biomolecules, and presented at major oncology conferences. EG BioMed’s CLIA and CAP accreditation enables US testing and reporting of research-use-only assays in an accredited laboratory environment.
YD Bio’s role includes coordinating commercialization, researcher engagement, and sample logistics for study use, complementing EG BioMed’s laboratory capabilities. The partnership represents ongoing collaboration between the companies to expand US laboratory access for molecular assays.
The test is currently for research use only and has not been cleared or approved by the US Food and Drug Administration. It is not intended to diagnose, treat, cure, or prevent any disease. YD Bio expects OkaiDx to provide a research-grade tool that may enable investigators to study post-treatment monitoring approaches and generate additional evidence for future clinical development.
ID 4680261 © Alexander Chelmodeev | Dreamstime.com
