YD Bio Limited Expands OkaiDx™ Testing Portfolio to Pancreatic and Colorectal Cancer Detection Across the U.S. and Provides Clinical Research Update on Pancreatic Cancer Early Detection

Rhea-AI Summary

YD Bio (Nasdaq: YDES) expanded U.S. access to its OkaiDx™ blood-based testing platform to include pancreatic and colorectal cancer detection across 44 states via EG BioMed’s CLIA/CAP lab in Washington, supported by a nationwide telehealth physician network and at‑home blood collection.

The company reported clinical results from an EG BioMed study (IRB ID: N202105091): 93.8% sensitivity for early‑stage (I–II) PDAC, 100% sensitivity in late‑stage PDAC, 97.3% specificity in healthy controls, and 97.7% overall accuracy in a 100‑patient PDAC / 500‑control dataset. The pancreatic test is not FDA cleared and results remain under validation.

Positive

• Expansion of OkaiDx testing to pancreatic and colorectal cancer across 44 states
• High early‑stage sensitivity of OkaiDx Detect: 93.8% for stage I–II PDAC
• Overall accuracy reported at 97.7% in the cited study
• Nationwide telehealth network and at‑home collection to streamline patient access
• MOUs with medical groups to integrate testing into primary care and women’s health

Negative

• Not FDA cleared for the OkaiDx Detect Pancreatic Cancer test
• Study size for PDAC cases was 100 patients, limiting broader validation

News Market Reaction

+3.68%

6 alerts

+3.68% News Effect

+10.3% Peak Tracked

-4.1% Trough Tracked

+$33M Valuation Impact

$933M Market Cap

1.4x Rel. Volume

On the day this news was published, YDES gained 3.68%, reflecting a moderate positive market reaction. Argus tracked a peak move of +10.3% during that session. Argus tracked a trough of -4.1% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $33M to the company's valuation, bringing the market cap to $933M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Early-stage PDAC sensitivity: 93.8% Late-stage PDAC sensitivity: 100% Specificity in healthy: 97.3% +5 more

8 metrics

Early-stage PDAC sensitivity 93.8% OkaiDx Detect Pancreatic Cancer Test (stage I–II PDAC)

Late-stage PDAC sensitivity 100% OkaiDx Detect Pancreatic Cancer Test (late-stage PDAC)

Specificity in healthy 97.3% Healthy individual controls in PDAC study

Overall accuracy 97.7% OkaiDx Detect Pancreatic Cancer Test performance

PDAC patients 100 patients Pancreatic ductal adenocarcinoma cohort size

Healthy controls 500 controls Healthy control cohort size

U.S. state coverage 44 states OkaiDx testing availability for pancreatic and colorectal cancer

IRB ID N202105091 Taipei Medical University-JIRB–approved PDAC study

Market Reality Check

Price: $11.03 Vol: Volume 146,593 is 1.32x t...

normal vol

$11.03 Last Close

Volume Volume 146,593 is 1.32x the 20-day average of 110,915, indicating elevated interest ahead of this update. normal

Technical Shares at $12.57 are trading below the 200-day MA of $14.92, despite positive clinical data and U.S. access expansion.

Peers on Argus

Peers in Biotechnology showed mixed single‑digit moves (e.g., BHVN +6.12%, JANX ...

Peers in Biotechnology showed mixed single‑digit moves (e.g., BHVN +6.12%, JANX -1.73%), with no clear sector‑wide direction, suggesting YDES trading was more stock‑specific.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Trade expo showcase	Positive	-18.4%	Showcased OkaiDx and precision medicine portfolios at Healthcare EXPO Taiwan.
Dec 02	Clinical data update	Positive	+3.7%	Expanded OkaiDx testing in U.S. and reported high‑performance PDAC detection data.
Nov 24	Regulatory milestone	Positive	+4.5%	Announced U.S. ophthalmology entry and FDA 510(k) clearance for Exovisse lenses.
Nov 05	Access expansion	Positive	-3.1%	Expanded U.S. access to OkaiDx breast cancer monitoring via CLIA/CAP lab.
Oct 20	Nasdaq listing	Positive	-0.9%	Rang Nasdaq opening bell to celebrate YDES listing and outlined growth plans.

Pattern Detected

Positive operational and clinical news has produced mixed reactions, with both strong rallies and sharp selloffs following seemingly favorable updates.

Recent Company History

Over the last few months, YD Bio (YDES) has highlighted commercialization and clinical progress across cancer diagnostics and ophthalmology. The company listed on Nasdaq on Oct 20, 2025, then expanded U.S. access to its OkaiDx™ breast cancer monitoring assay on Nov 5. On Nov 24, it reported U.S. ophthalmology milestones, followed by showcasing its portfolio at Healthcare EXPO Taiwan in early December. Today’s expansion of OkaiDx testing to pancreatic and colorectal cancer with strong PDAC performance metrics builds directly on this diagnostics-focused trajectory.

Market Pulse Summary

This announcement details broader U.S. availability of OkaiDx blood-based testing for pancreatic and...

Analysis

This announcement details broader U.S. availability of OkaiDx blood-based testing for pancreatic and colorectal cancer across 44 states and presents encouraging PDAC data, including 93.8% early-stage sensitivity and 97.7% overall accuracy in a 100-patient and 500-control study. It builds on prior OkaiDx and ophthalmology milestones while noting that the pancreatic test is not FDA cleared and remains under validation. Investors may watch for further clinical validation, regulatory developments, and commercialization updates to assess long-term impact.

Key Terms

dna methylation, clia/cap-certified laboratory, telehealth, pancreatic ductal adenocarcinoma, +3 more

7 terms

dna methylation medical

"a biotechnology company advancing DNA methylation-based cancer detection technology"

A chemical tag added to DNA that acts like a sticky note on a recipe, changing whether a gene is read without altering the underlying genetic code. For investors, DNA methylation matters because these tags can serve as measurable biomarkers for disease diagnosis, risk prediction, and treatment response, and they can be targets for drugs or diagnostic tests—factors that influence clinical value, regulatory approval, and market potential.

clia/cap-certified laboratory regulatory

"OkaiDx breast cancer monitoring assay available through EG BioMed’s CLIA/CAP‑certified laboratory"

A CLIA/CAP-certified laboratory is a medical testing facility that meets federal rules (CLIA) and professional quality standards set by a national laboratory accreditation program (CAP), meaning its processes, equipment and staff competence have been independently inspected and approved. Investors care because results from such labs are more reliable and accepted by regulators, doctors and payers, which reduces scientific, regulatory and commercial risk for diagnostics, drug trials and healthcare products — like choosing a restaurant that passed both health inspections and chef reviews.

telehealth technical

"Access is supported by a nationwide telehealth physician network that provides virtual consultations"

Telehealth is the delivery of healthcare services and consultations remotely using video calls, phone, text messaging, or connected devices to monitor and transmit medical information. It matters to investors because it can reshape how patients access care, lower costs, and create new revenue streams or risks for healthcare providers, insurers and technology companies—similar to how online banking changed financial services—while also exposing businesses to reimbursement and regulatory shifts.

pancreatic ductal adenocarcinoma medical

"sensitivity for early‑stage (stage I–II) pancreatic ductal adenocarcinoma (PDAC)"

A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.

cfdna methylation biomarkers medical

"These data underscore the potential of cfDNA methylation biomarkers, including ZFP30"

Circulating cell-free DNA (cfDNA) methylation biomarkers are tiny fragments of DNA floating in the bloodstream that carry chemical tags called methylation marks, which act like sticky notes indicating which genes are turned on or off and which tissue they came from. Investors care because these patterns can reveal early signs of disease, track treatment response or detect recurrence from a simple blood draw, making them a high‑value foundation for diagnostic tests, monitoring services and related healthcare markets.

u.s. food and drug administration regulatory

"The OkaiDx Detect Pancreatic Cancer test has not been cleared or approved by the U.S. Food and Drug Administration"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

irb regulatory

"conducted under Taipei Medical University-JIRB approval (IRB ID: N202105091)"

An Institutional Review Board (IRB) is an independent committee that reviews and approves medical and behavioral research involving people to ensure safety, informed consent, and ethical treatment—think of it as a safety inspector for studies. For investors, IRB decisions matter because their approval or requests for changes can speed up, delay, or halt clinical trials and other studies, directly affecting timelines, costs, and the value of companies developing treatments.

AI-generated analysis. Not financial advice.

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
Email: investor@ydesgroup.com

WFS Investor Relations Inc.
Email: services@wealthfsllc.com
Phone: +1 628 283 9214

FAQ

What did YD Bio (YDES) announce on December 2, 2025 about OkaiDx testing?

YD Bio expanded OkaiDx U.S. services to include pancreatic and colorectal cancer detection across 44 states and shared pancreatic study results.

What accuracy and sensitivity did the OkaiDx pancreatic study report for YDES?

The EG BioMed study reported 97.7% overall accuracy, 93.8% sensitivity for early‑stage PDAC and 100% sensitivity in late‑stage PDAC.

Is the OkaiDx Detect Pancreatic Cancer test FDA cleared for use in the U.S. (YDES)?

No; the announcement states the pancreatic test has not been cleared or approved by the U.S. FDA and remains under validation.

How is YD Bio (YDES) making OkaiDx testing accessible to U.S. patients?

Access is via EG BioMed’s CLIA/CAP lab in Washington covering 44 states, a nationwide telehealth physician network, and an at‑home blood collection partner.

What clinical evidence supports YD Bio’s pancreatic detection claims (YDES)?

EG BioMed’s IRB‑approved study (IRB ID: N202105091) tested 100 PDAC patients and 500 healthy controls, reporting the cited sensitivity and specificity figures.