YD Bio updates on OkaiDx™ platform expansion for cancer detection, reporting significant advances in pancreatic cancer diagnostics.
Quiver AI Summary
YD Bio Limited has announced significant progress in expanding its OkaiDx™ platform for cancer detection, specifically for pancreatic and colorectal cancers, with new advances in early pancreatic cancer detection. The Company has broadened the availability of its blood-based testing services to 44 states in the U.S. through a collaboration with EG BioMed’s certified laboratory, complemented by a nationwide telehealth network for patient support. Recent data from an ongoing study of the OkaiDx Detect Pancreatic Cancer Test indicate high sensitivity and specificity, particularly for early-stage pancreatic ductal adenocarcinoma. Although the test has not been cleared by the FDA and remains under validation, these findings highlight the potential of cfDNA methylation biomarkers for enhancing early cancer detection. YD Bio continues to focus on improving patient outcomes through innovative approaches in biotechnology.
Potential Positives
- YD Bio has expanded the OkaiDx™ blood-based testing platform to include pancreatic and colorectal cancer detections, enhancing its product offerings.
- The assay for early-stage pancreatic cancer detection demonstrated a high sensitivity of 93.8% and overall accuracy of 97.7%, indicating strong potential for effective early diagnosis.
- The company has broadened clinical service availability across 44 states in the U.S., improving access to cancer monitoring services for patients.
- New partnerships with medical groups will integrate OkaiDx testing into clinical workflows, promoting proactive detection and monitoring in primary care and women's health settings.
Potential Negatives
- The OkaiDx Detect Pancreatic Cancer test has not been cleared or approved by the U.S. Food and Drug Administration, indicating regulatory uncertainties regarding its use in clinical practices.
- Results from the ongoing study remain under validation, which may affect confidence in the product's reliability until completed and officially recognized.
- Forward-looking statements caution that actual results may differ materially from the company's expectations, which could concern investors about future performance.
FAQ
What is the OkaiDx™ platform?
The OkaiDx™ platform is a blood-based testing system for cancer detection, including breast, pancreatic, and colorectal cancers.
How accurate is the OkaiDx Detect Pancreatic Cancer Test?
The test demonstrated 93.8% sensitivity for early-stage pancreatic ductal adenocarcinoma and 97.7% overall accuracy in clinical studies.
In which states is the OkaiDx platform available?
The OkaiDx platform is currently available across 44 states in the U.S.
What partnerships has YD Bio established for cancer detection?
YD Bio has executed memorandums with medical groups to integrate OkaiDx testing into clinical workflows for enhanced detection.
Are the results from the OkaiDx tests approved by the FDA?
No, the OkaiDx tests have not been cleared or approved by the U.S. Food and Drug Administration; they are still under validation.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$YDES Hedge Fund Activity
We have seen 9 institutional investors add shares of $YDES stock to their portfolio, and 0 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- GEODE CAPITAL MANAGEMENT, LLC added 53,071 shares (+inf%) to their portfolio in Q3 2025, for an estimated $1,033,292
- CERITY PARTNERS LLC added 32,406 shares (+inf%) to their portfolio in Q3 2025, for an estimated $630,944
- HRT FINANCIAL LP added 31,819 shares (+inf%) to their portfolio in Q3 2025, for an estimated $619,515
- CYPRESS CAPITAL MANAGEMENT LLC (WY) added 29,990 shares (+inf%) to their portfolio in Q3 2025, for an estimated $583,905
- UBS GROUP AG added 10,316 shares (+inf%) to their portfolio in Q3 2025, for an estimated $200,852
- MORGAN STANLEY added 10,257 shares (+inf%) to their portfolio in Q3 2025, for an estimated $199,703
- BNP PARIBAS FINANCIAL MARKETS added 90 shares (+inf%) to their portfolio in Q3 2025, for an estimated $1,752
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Taipei, Taiwan, Dec. 02, 2025 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today provided an update to its November 5, 2025 announcement regarding U.S. access to the OkaiDx ™ platform for post‑treatment breast cancer monitoring, detailing the continued expansion of OkaiDx ™ blood‑based testing platform to pancreatic and colorectal cancer detections while presenting new clinical advances in early pancreatic cancer detection.
Building on the Company’s previously announced support for the research‑use‑only OkaiDx breast cancer monitoring assay available through EG BioMed’s CLIA/CAP‑certified laboratory, YD Bio and its affiliate have broadened clinical service availability of the OkaiDx platform in the United States. The Company now offers blood‑based testing services for pancreatic and colorectal cancer detection across 44 states through EG BioMed’s accredited laboratory in Washington. Access is supported by a nationwide telehealth physician network that provides virtual consultations, test authorization, and ongoing patient support, together with an at‑home blood collection partner that streamlines sample collection and logistics for patients and research collaborators.
To extend reach in family primary care and women’s health settings, YD Bio and EG BioMed have executed new memorandums of understanding with multiple medical groups. These partnerships integrate OkaiDx testing into everyday clinical workflows and expand access for individuals who may benefit from proactive detection and monitoring in the U.S.
The Company would also like to share important updated data from YD Bio’s affiliate EG BioMed US Inc.’s ongoing study of the OkaiDx Detect Pancreatic Cancer Test, conducted under Taipei Medical University-JIRB approval (IRB ID: N202105091). The assay demonstrated 93.8% sensitivity for early‑stage (stage I–II) pancreatic ductal adenocarcinoma (PDAC), 100% sensitivity in late‑stage PDAC, 97.3% specificity in healthy individuals, and 97.7% overall accuracy in a study of 100 PDAC patients and 500 healthy controls. These data underscore the potential of cfDNA methylation biomarkers, including ZFP30, to improve detection at earlier stages when treatment options may be more effective.
The OkaiDx Detect Pancreatic Cancer test has not been cleared or approved by the U.S. Food and Drug Administration, results are from an independently conducted EG BioMed study and remain under validation.
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
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