UCL spin-out achieves FDA Breakthrough Designation with Hardian
UCL spin-out Guildford Street Laboratories (GSL) has achieved a landmark milestone with their blood-based test, PD Predict, receiving FDA Breakthrough Device Designation.
Guided by Hardian Health’s regulatory expertise, this milestone reflects the strength of GSL’s approach, blending advanced biomarker analysis with machine learning to achieve exceptional diagnostic accuracy.
PD Predict addresses the limitations of conventional Parkinson’s diagnosis, which is often slow and prone to misdiagnosis due to symptom overlap with other neurological disorders. Traditional diagnostic methods can extend over six months to three years, with misdiagnosis rates alarmingly high. By offering a faster and more reliable means to identify the disease early, PD Predict aims to significantly improve patient outcomes and streamline the diagnostic process.
The founding vision
Professor Kevin Mills, Professor of Biochemistry at University College London and Honorary Clinical Scientist at Great Ormond Street Hospital, co-founded GSL to tackle the critical lack of effective diagnostic tools for neurodegenerative diseases. His own academic and clinical experience revealed the challenges patients and clinicians face with slow and often inaccurate Parkinson’s diagnoses.
Recognising that relying on single biomarkers often led to inconclusive results – especially in regard to neurodegenerative diseases – the GSL team pursued a multi-biomarker strategy, applying advanced machine learning to translate their groundbreaking findings into clinical practice.
The development of PD Predict
PD Predict offers a blood-based test that measures eight biomarkers, using machine learning to refine the data and achieve exceptional accuracy. The development journey was ambitious, given that Parkinson’s disease isn’t well understood. To ensure the test’s robustness and specificity, GSL collaborated with international clinicians, training AI algorithms with extensive, high-quality datasets and meeting stringent regulatory standards.
By integrating both neurological and inflammatory biomarkers, PD Predict provides a holistic view of Parkinson’s, capturing the disease's complexity more effectively than conventional methods. By prioritising speed and precision, PD Predict has the potential to improve early detection and patient outcomes in a critical area of healthcare.
Choosing the FDA Breakthrough Pathway
The FDA Breakthrough Device Designation is an expedited pathway designed to fast-track the development and review of devices that address serious conditions. To qualify, a device must demonstrate potential for substantial improvement over existing options. This pathway streamlines development and review, demonstrating the FDA’s dedication to addressing critical unmet needs and delivering better outcomes for patients.
When it came to navigating the complex regulatory landscape, GSL knew they needed a strategic approach to bring PD Predict to market efficiently. Opting for the FDA Breakthrough Device Designation was a deliberate decision, offering advantages that traditional regulatory routes could not provide, such as expedited feedback, sprint sessions, and an overall streamlined approval process.
Through collaborative workshops and ongoing strategy meetings, every step of the submission process was meticulously planned and executed. This enhanced the quality of the regulatory submissions and enabled GSL to respond swiftly to FDA queries, ultimately accelerating PD Predict's path to market.
"What it has allowed us to do now is start mapping and focussing on full pre-market approval or regulatory submissions, and has helped us accelerate the process." – Tomas Baldwin, Co-founder of GSL
Hardian Health’s Role
The Hardian Health team was able to provide more than just guidance throughout the process, we engaged in a strategic partnership that helped GSL adapt to evolving regulatory standards and ensure they were able to achieve FDA Breakthrough Designation with ease.
Cybersecurity and risk management were key priorities for GSL. We are working together closely to identify potential vulnerabilities, implement robust safeguards, and ensure patient data remains secure. By addressing compliance requirements we will reinforce the integrity of the submission and also build a foundation of trust and resilience for PD Predict’s deployment in clinical settings.
By collaborating closely with GSL to refine documentation and implement essential cybersecurity measures we ensured readiness for urgent situations. This proved invaluable when an FDA query required a rapid, high-quality response within 24 hours. As a result of this preparation, we acted swiftly, avoiding any delays in the approval timeline.
This collaborative effort paid off: PD Predict secured Breakthrough Designation faster than typical submissions due to the dedication of both teams to meet the highest standards in healthcare diagnostics.
"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." – Tomas Baldwin, Co-founder of GSL
Future plans
Securing the FDA Breakthrough Designation has significantly enhanced GSL's credibility in the competitive diagnostics market, positioning them as leaders in proteomic diagnostics. With this achievement, GSL is poised to expand PD Predict's reach, leveraging FDA pathways to expedite future innovations and bring them to patients more swiftly.
Looking ahead, GSL plans to extend their diagnostic platform to address other high-impact conditions, including developing a test for hypertrophic cardiomyopathy to identify individuals at risk of sudden cardiac events, and antibody testing for gene therapies to tackle challenges in gene replacement treatments.
This strategic expansion leverages its core technology to pursue further validations and clinical investigations, reflecting GSL’s commitment to using science-driven innovation to meet unmet clinical needs and improve diagnostics for complex diseases.
With a solid foundation in place, GSL is focused on its vision in transforming patient care through innovation and precision diagnostics.
"It also gives us the opportunity to decide whether we want our other products to pursue FDA breakthrough designation. It's a wonderful opportunity for PD Predict, and it allows us to sense-check and stress-test the process for the other products we're developing." – Tomas Baldwin, Co-founder of GSL
As dedicated partners in healthcare innovation, we take pride in supporting transformative technologies like PD Predict. With a strong foundation now in place, we look forward to seeing its impact on accelerating Parkinson’s diagnosis and improving care for patients facing this challenging condition.
Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property
