YD Bio and EG BioMed Expand U.S. Access to OkaiDx™, a cfDNA‑Methylation Blood Test for Post‑Treatment Breast Cancer Monitoring

Rhea-AI Summary

YD Bio (NasdaqGM: YDES) announced support for U.S. access to OkaiDx™, a cfDNA‑methylation blood test for post‑treatment breast cancer monitoring, now available through affiliate EG BioMed’s CLIA/CAP‑certified laboratory as a research‑use‑only (RUO) assay.

The company will coordinate commercialization, researcher engagement and sample logistics to enable testing for research laboratories, academic groups and industry partners. Independent validation reported 95.1% accuracy, 89.4% sensitivity and 96.5% specificity. OkaiDx™ is not FDA cleared and is not intended to diagnose, treat, cure or prevent disease.

Positive

• Independent validation: 95.1% accuracy
• Independent validation: 89.4% sensitivity
• Independent validation: 96.5% specificity
• EG BioMed CLIA/CAP accreditation enables U.S. RUO testing

Negative

• RUO status limits use to research, not clinical diagnosis
• Not FDA cleared, restricting clinical adoption and reimbursement

Insights

Molecular diagnostics commercialization analyst

YD Bio expands U.S. RUO access to a cfDNA‑methylation breast cancer monitoring assay via an accredited CLIA/CAP lab.

YD Bio and affiliate EG BioMed enable U.S. laboratory reporting of the OkaiDx™ research‑use‑only assay through EG BioMed’s CLIA/CAP‑certified facility, with YD Bio coordinating commercialization, researcher engagement and sample logistics. The announcement highlights independent performance figures of 95.1% accuracy, 89.4% sensitivity and 96.5% specificity and notes prior peer‑reviewed publications and conference presentations supporting research use.

Key dependencies and risks include the assay’s current RUO status and explicit statement that it is not FDA cleared or intended for diagnosis or treatment; regulatory clearance would be required before clinical use. Watch for published validation datasets, adoption by academic surveillance studies, and any moves toward clinical validation or regulatory submission over the next 6–24 months (6–24 months), which would materially change the opportunity.

Taipei, Taiwan, Nov. 05, 2025 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (NasdaqGM: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced its support for the global commercialization of OkaiDx^™, a research‑use‑only (RUO) blood test for post‑treatment breast cancer monitoring now available through the Company’s affiliate EG Biomed US Inc. (“EG BioMed”)’s CLIA/CAP‑certified laboratory in the United States. YD Bio’s role is to support commercialization efforts for OkaiDx^™ under the authorization granted to the Company, working alongside EG BioMed to make the assay accessible to research laboratories, academic groups and industry partners conducting surveillance and translational studies.

OkaiDx^™ was developed through international scientific collaboration and uses cfDNA methylation profiling to generate molecular surveillance information for research settings. The test has been reported in peer‑reviewed journals such as Clinical Epigenetics and Biomolecules, and presented at major oncology conferences. EG BioMed’s CLIA and CAP accreditation enables U.S. testing and reporting of RUO assays in an accredited laboratory environment, while YD Bio’s support complements EG BioMed’s laboratory capabilities by helping coordinate commercialization, researcher engagement and sample logistics for study use.

YD Bio’s involvement follows its ongoing partnership activities with EG BioMed to expand U.S. laboratory access for cutting‑edge molecular assays, said Dr. Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio Limited. “Independent validation already reported performance metrics of 95.1% accuracy, 89.4% sensitivity and 96.5% specificity,” he said.

YD Bio is helping to commercialize OkaiDx^™ for research applications. As of present day, the test is for research use only, and has not been cleared or approved by the U.S. Food and Drug Administration, and is not intended to diagnose, treat, cure or prevent any disease. The Company expects OkaiDx^™ to provide a research‑grade tool that may enable investigators to study post‑treatment monitoring approaches and to generate additional evidence that could inform future clinical development.

About YD Bio Limited

YD Bio Limited is a biotechnology company focused on advancing clinical trials, new drug development, cancer prevention diagnostics, and stem cell and exosome therapies with the potential to transform the treatment of diseases with high unmet medical need. The Company is committed to improving patient outcomes through scientific innovation and precision medicine. In addition to its R&D efforts, YD Bio Limited is a recognized supplier of clinical trial drugs and has expanded into the development and distribution of post-market auxiliary products. For more information, please visit the Company’s website: ir.ydesgroup.com

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements, including, but not limited to, YD Bio’s business plan and outlook. These forward-looking statements involve known and unknown risks and uncertainties and are based on YD Bio’s current expectations and projections about future events that YD Bio believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. YD Bio undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although YD Bio believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and YD Bio cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in YD Bio’s registration statement and other filings with the U.S. Securities and Exchange Commission.

For investor and media inquiries, please contact:
YD Bio Limited
Investor Relations 
Email: investor@ydesgroup.com

FAQ

What is OkaiDx™ and who offers it in the U.S. (YDES)?

OkaiDx™ is a cfDNA‑methylation RUO blood test for post‑treatment breast cancer monitoring, available in the U.S. via EG BioMed with commercialization support from YD Bio (YDES).

What performance metrics were reported for OkaiDx™ (YDES)?

Independent validation reported 95.1% accuracy, 89.4% sensitivity and 96.5% specificity.

Is OkaiDx™ FDA approved for clinical use (YDES)?

No; OkaiDx™ is research‑use‑only and has not been cleared or approved by the FDA.

How does EG BioMed’s lab accreditation affect OkaiDx™ availability (YDES)?

EG BioMed’s CLIA and CAP accreditation enables U.S. testing and reporting of RUO assays in an accredited laboratory environment.

Who can order OkaiDx™ in the U.S. with YD Bio’s support (YDES)?

The test is accessible to research laboratories, academic groups and industry partners conducting surveillance and translational studies.

What is YD Bio’s role in OkaiDx™ commercialization (YDES)?

YD Bio supports commercialization by coordinating researcher engagement, sample logistics and partner outreach for study use in the U.S.