"M10 excludes biomarkers." I hear this constantly from biopharma teams.

And technically? It's true.

The M10 guidance explicitly states it doesn't cover biomarkers.

But here's what most teams miss:

The FDA's 2025 biomarker guidance says the exact opposite.

When biomarker data supports regulatory decision-making—like pivotal safety/effectiveness determinations, dosage instructions, or maybe even to support a story for accelerated approval—M10 validation IS required.

The catch?

Neither document mentions Context of Use.

And that's where teams get stuck.

Because biomarker accuracy and precision criteria aren't one-size-fits-all.

They depend on:
→ Your biomarker's dynamic range and signal to noise ratio
→ The effect size that matters clinically
→ Whether you're measuring an increase or decrease
→ The types of samples you are expecting to get in the trial
→ How the data will inform regulatory decisions

Translation:

You can't just "follow M10" for biomarkers.
You need to define your Context of Use first.

Then build validation criteria that actually support your regulatory strategy.

The teams that get this right?
They're the ones not scrambling in Phase 2 to explain why their biomarker data doesn't hold up under FDA scrutiny.

P.S. Is your team assuming M10 doesn't apply to your biomarkers—or have you mapped your Context of Use to validation requirements?

📌 Links in comments:
FDA M10 Guidance
FDA Biomarker Guidance