YDX Group: Helping Diagnostics Innovators Move Faster With Confidence

Jan 20

Written By Yun-Fu HU

Passion. Experience. Diligence.

These words have guided our careers for decades ─ and they are the reason we founded The YDX Group.

We started YDX because we believe that transformative diagnostics and medical technologies deserve more than good science. They deserve a regulatory strategy that is just as rigorous, just as thoughtful, and just as committed to improving lives.

Today, teams are pushing the boundaries of precision medicine: molecular diagnostics, liquid biopsy, cancer screening, companion diagnostics, digital pathology, and AI-enabled technologies are evolving at extraordinary speed. At the same time, regulatory expectations are evolving too ─ sometimes quickly, sometimes unevenly, and often with high stakes.

We’ve lived that evolution firsthand. And we founded YDX to help innovators navigate it with clarity, confidence, and credibility.

Our Genesis: Three FDA Leaders, One Shared Purpose

The YDX Group was founded by Dr. Yun-Fu Hu, Dr. Donna Roscoe, and Dr. Xueying (Sharon) Liang. We met while working at the Division of Molecular Genetics and Pathology (DMGP) at FDA ─ the group entrusted to regulate IVDs and LDTs across a wide spectrum of technologies, including:

Genetic testing
Molecular cancer diagnostics (e.g., liquid biopsy, cancer screening, monitoring, minimal residual disease)
Companion / complementary diagnostics
Digital pathology
Artificial intelligence devices

For more than a decade, we worked together through major shifts in the regulatory landscape. We served in senior leadership roles and participated in the real work behind regulatory decisions: evaluating evidence, shaping policy, and asking the questions that determine whether a technology is ready for patients.

The Moment We Knew YDX Needed to Exist

Over the years, we saw the same pattern again and again.

We saw promising technologies slowed down not by lack of innovation, but by lack of regulatory clarity early enough to make the right development choices. We saw teams invest heavily in studies that didn’t answer the questions regulators would ask. We saw brilliant scientists struggle to translate complex evidence into a clear and defensible story. And we saw timelines slip because communication with regulators wasn’t structured for success.

Those moments stayed with us.

They helped shape our belief that successful regulatory strategy is built on sound science, transparent communication, and trusted relationships ─ and that every team deserves direct access to experienced experts who can help them make the right high-stakes decisions at the right time.

That’s why we founded YDX.

What YDX Stands For

The name YDX reflects the first names of our three founders: Yun-Fu, Donna, and Xueying (Sharon).

But the name also represents our mission:

To empower innovation, mitigate risks, optimize resources, and deliver tailored solutions that address unmet medical needs ─ so that breakthrough technologies can reach the people who need them.

Or, in the words of one of our favorite lines:

YDX ─ Your Development eXpedited.

What We Do: Regulatory Strategy That Moves Development Forward

At YDX, we provide high-quality regulatory consulting from former FDA leaders, helping innovators accelerate the development and approval of diagnostics, medical devices, and precision medicine solutions.

Headquartered in Bethesda, Maryland, we specialize in **global in vitro diagnostics device regulations** ─ supporting everything from design controls to test validations, and from FDA to EU and China. We guide clients through the complexities of R&D, manufacturing, clinical trials, and regulatory compliance with strategic insight and practical execution.

Who We Help

We work with organizations across the diagnostic and precision medicine ecosystem, including:

Diagnostics and medtech startups building their first regulatory strategy
Pharmaceutical and biotech teams developing companion diagnostics and biomarker programs
Digital health and AI innovators navigating evolving policy expectations
Established companies expanding globally across FDA, EU IVDR, and China pathways
Investors and boards seeking independent regulatory risk assessment for high-stakes decisions

Whether you’re early-stage or approaching submission, our role is the same: help you build a plan that stands up to scrutiny and supports success.

How We Help: Six Ways We Support Innovation

We structure support based on what our clients need most ─ whether that’s early strategy, FDA interaction, submission planning, or evidence gap resolution.

Our core service areas include:

1) Regulatory Pathway Assessment & Strategic Planning

We help teams identify the most efficient, evidence-based pathway tailored to their product, risk profile, and development stage—and create a clear, defensible plan aligned with FDA expectations.

2) FDA Engagement, Submission Planning & Review Support

From Q-Sub strategy to briefing packages, mock Q&A, and interactive review response cycles, we help teams communicate effectively with FDA and anticipate reviewer expectations.

3) Companion Diagnostics Strategy & Co-Development Guidance

We help teams align diagnostic and therapeutic development ─ from biomarker strategy through analytical/clinical validation planning and global regulatory alignment.

4) AI/ML & Digital Health Regulatory Support

We help innovators interpret evolving policy, structure evidence, and prepare for expectations around transparency, performance, and lifecycle management.

5) Evidence Evaluation & Scientific Advisory

We bring experience reviewing hundreds of diagnostics and devices to help teams strengthen their evidence packages ─ analytical, clinical, statistical, and risk-benefit.

6) Regulatory Risk Assessment for Investors & Boards

We provide independent, FDA-informed risk and pathway assessments to support investment, acquisition, and portfolio decisions.

How We Work: Direct, Transparent, and Hands-On

At YDX, you work directly with seasoned regulatory leaders ─ not a layered consulting structure.

We structure our support to fit each client’s needs ─ from early concept discussions to submission planning and FDA interaction. Our engagements are:

Collaborative and hands-on
Focused on clear, actionable recommendations
Tailored for diagnostics, devices, and digital health innovation
Confidential and trusted, especially for high-stakes regulatory decisions

Our Mission (and Our Promise)

We founded YDX because we believe innovation should not be slowed by avoidable regulatory uncertainty.

Our mission is to provide the clarity and trusted judgment that helps teams make the right decisions early, build evidence intelligently, communicate effectively with regulators, and ultimately bring meaningful technologies to patients faster.

Or, in one line:

Where Regulatory Authority Meets Innovation.

Let’s Build a Successful Pathway Forward

Whether you are preparing a Q-Sub meeting, evaluating regulatory pathways, planning a submission, or seeking high-level strategic insight, we’re here to help.

If you’d like to explore how YDX can support your program, reach out at:

📩 contact@theydxgroup.com
📞 (301) 660-7360

YDX ─ Your Development eXpedited.

Yun-Fu HU

YDX Group: Helping Diagnostics Innovators Move Faster With Confidence

Passion. Experience. Diligence.

These words have guided our careers for decades ─ and they are the reason we founded The YDX Group.

We started YDX because we believe that transformative diagnostics and medical technologies deserve more than good science. They deserve a regulatory strategy that is just as rigorous, just as thoughtful, and just as committed to improving lives.

We’ve lived that evolution firsthand. And we founded YDX to help innovators navigate it with clarity, confidence, and credibility.

Our Genesis: Three FDA Leaders, One Shared Purpose

The YDX Group was founded by Dr. Yun-Fu Hu, Dr. Donna Roscoe, and Dr. Xueying (Sharon) Liang. We met while working at the Division of Molecular Genetics and Pathology (DMGP) at FDA ─ the group entrusted to regulate IVDs and LDTs across a wide spectrum of technologies, including:

Genetic testing

Molecular cancer diagnostics (e.g., liquid biopsy, cancer screening, monitoring, minimal residual disease)

Companion / complementary diagnostics

Digital pathology

Artificial intelligence devices

The Moment We Knew YDX Needed to Exist

Over the years, we saw the same pattern again and again.

Those moments stayed with us.

They helped shape our belief that successful regulatory strategy is built on sound science, transparent communication, and trusted relationships ─ and that every team deserves direct access to experienced experts who can help them make the right high-stakes decisions at the right time.

That’s why we founded YDX.

What YDX Stands For

The name YDX reflects the first names of our three founders: Yun-Fu, Donna, and Xueying (Sharon).

But the name also represents our mission:

To empower innovation, mitigate risks, optimize resources, and deliver tailored solutions that address unmet medical needs ─ so that breakthrough technologies can reach the people who need them.

Or, in the words of one of our favorite lines:

YDX ─ Your Development eXpedited.

What We Do: Regulatory Strategy That Moves Development Forward

At YDX, we provide high-quality regulatory consulting from former FDA leaders, helping innovators accelerate the development and approval of diagnostics, medical devices, and precision medicine solutions.

Who We Help

We work with organizations across the diagnostic and precision medicine ecosystem, including:

Diagnostics and medtech startups building their first regulatory strategy

Pharmaceutical and biotech teams developing companion diagnostics and biomarker programs

Digital health and AI innovators navigating evolving policy expectations

Established companies expanding globally across FDA, EU IVDR, and China pathways

Investors and boards seeking independent regulatory risk assessment for high-stakes decisions

Whether you’re early-stage or approaching submission, our role is the same: help you build a plan that stands up to scrutiny and supports success.

How We Help: Six Ways We Support Innovation

We structure support based on what our clients need most ─ whether that’s early strategy, FDA interaction, submission planning, or evidence gap resolution.

Our core service areas include:

1) Regulatory Pathway Assessment & Strategic Planning

We help teams identify the most efficient, evidence-based pathway tailored to their product, risk profile, and development stage—and create a clear, defensible plan aligned with FDA expectations.

2) FDA Engagement, Submission Planning & Review Support

From Q-Sub strategy to briefing packages, mock Q&A, and interactive review response cycles, we help teams communicate effectively with FDA and anticipate reviewer expectations.

3) Companion Diagnostics Strategy & Co-Development Guidance

We help teams align diagnostic and therapeutic development ─ from biomarker strategy through analytical/clinical validation planning and global regulatory alignment.

4) AI/ML & Digital Health Regulatory Support

We help innovators interpret evolving policy, structure evidence, and prepare for expectations around transparency, performance, and lifecycle management.

5) Evidence Evaluation & Scientific Advisory

We bring experience reviewing hundreds of diagnostics and devices to help teams strengthen their evidence packages ─ analytical, clinical, statistical, and risk-benefit.

6) Regulatory Risk Assessment for Investors & Boards

We provide independent, FDA-informed risk and pathway assessments to support investment, acquisition, and portfolio decisions.

How We Work: Direct, Transparent, and Hands-On

At YDX, you work directly with seasoned regulatory leaders ─ not a layered consulting structure.

We structure our support to fit each client’s needs ─ from early concept discussions to submission planning and FDA interaction. Our engagements are:

Collaborative and hands-on

Focused on clear, actionable recommendations

Tailored for diagnostics, devices, and digital health innovation

Confidential and trusted, especially for high-stakes regulatory decisions

Our Mission (and Our Promise)

We founded YDX because we believe innovation should not be slowed by avoidable regulatory uncertainty.

Our mission is to provide the clarity and trusted judgment that helps teams make the right decisions early, build evidence intelligently, communicate effectively with regulators, and ultimately bring meaningful technologies to patients faster.

Or, in one line:

Where Regulatory Authority Meets Innovation.

Let’s Build a Successful Pathway Forward

Whether you are preparing a Q-Sub meeting, evaluating regulatory pathways, planning a submission, or seeking high-level strategic insight, we’re here to help.

If you’d like to explore how YDX can support your program, reach out at:

📩 contact@theydxgroup.com 📞 (301) 660-7360

YDX ─ Your Development eXpedited.

FDA Draft Guidance on MRD Endpoints in Multiple Myeloma: What It Means for Drug Developers and IVD Innovators

📩 contact@theydxgroup.com
📞 (301) 660-7360