Guildford Street Laboratories
Guildford Street Laboratories is a UCL spin-out developing blood-based diagnostic tests that combine multi-biomarker analysis with machine learning. Founded to address gaps in neurological and cardiac diagnostics, GSL’s platform underpins PD Predict for Parkinson’s disease and HCM Predict for hypertrophic cardiomyopathy, both designed to improve speed, accuracy, and early detection in conditions with high unmet clinical need.
We supported Guildford Street Laboratories in securing two back-to-back FDA Breakthrough Device Designations for PD Predict and HCM Predict
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What they needed
They needed regulatory expertise to pursue the FDA Breakthrough Device pathway for two AI-driven diagnostic products in parallel. This required a clear regulatory strategy, robust submissions capable of withstanding expedited FDA scrutiny, and support navigating evolving requirements around evidence, risk management, and cybersecurity, all while maintaining momentum across a growing diagnostic pipeline.
Who are they?
Antony Tomas Baldwin,
Co-founder, Guildford Street Laboratories:
“The Hardian team helped us put together credible regulatory submissions – that was the first challenge they assisted us with – and they continued to help us immeasurably after, too.”
“The Hardian team helped us put together credible regulatory submissions – that was the first challenge they assisted us with – and they continued to help us immeasurably after, too.”
Antony Tomas Baldwin,
Co-founder, Guildford Street Laboratories
How we helped
We worked closely with GSL as a strategic partner, shaping the Breakthrough Device strategy, refining submissions, and preparing the team for rapid FDA engagement. We strengthened documentation, supported cybersecurity and risk management planning, and ensured readiness for fast-turnaround FDA queries, enabling confident, timely responses without disrupting progress.
The result
Alongside the back-to-back FDA Breakthrough Device Designations for PD Predict and HCM Predict, the designations accelerated regulatory dialogue, validated the strength of GSL’s science and evidence strategy, and positioned the company to move efficiently toward full regulatory approval while supporting expansion into additional high-impact diagnostic indications.