Diagnostics.ai launches first CE-IVDR transparent AI platform
Diagnostics.ai has launched what it claims is the industry’s first fully transparent machine learning platform for clinical real-time PCR diagnostics, achieving CE-IVDR certification as new European regulatory deadlines take effect. The PCR.AI platform represents a significant advancement in diagnostic AI transparency, demonstrating exactly how each result is achieved – a first for molecular testing machine learning applications.
Revolutionary transparency in diagnostic AI
The CE-IVDR Strategic Advantage Platform addresses the stringent requirements of the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), which demands heightened standards for diagnostic accuracy, reproducibility, and algorithm transparency. Unlike traditional diagnostic algorithms that remain opaque “black boxes,” PCR.AI was engineered with transparency built into its foundation.
“While most diagnostic algorithms remain an impenetrable ‘black box,’ the PCR.AI API was engineered with transparency included from the ground up,” said Aron Cohen, CEO of Diagnostics.ai. “Our platform delivers transparency and traceability that meet and support the highest standards set by CE-IVDR, making the AI decision-making process visible, understandable, and traceable.”
Clinical validation and proven accuracy
The technology is supported by over 15 years of clinical experience and millions of successfully processed samples, with documented accuracy exceeding 99.9%. Independent validation studies involving over 250,000 samples have confirmed the platform’s reliability across diverse laboratory settings and pathogen types.
Dr Brian Glenville MD, Chairman of Diagnostics.ai, emphasised the clinical significance: “Our platform bridges the gap between compliance necessity and clinical confidence. Laboratory directors can now explain to regulators, clinicians, and patients exactly how each diagnostic result was determined, creating a new level of trust in molecular diagnostics.”
Key technical innovations
PCR.AI’s architecture centres on a pioneering “model-aware” design that enables laboratories to understand AI-generated recommendations. The platform offers several critical capabilities:
- Transparent result attribution that directly shows how and why results were achieved, eliminating reliance on post-hoc interpretations
- Real-time model monitoring allowing laboratories to track performance and detect drift, meeting IVDR Article 72 requirements
- Per-test algorithm accountability with comprehensive auditability features
- Clinician-ready explanation generation providing clear, auditable explanations for clinical communication
Regulatory compliance and availability
The platform maintains full CE-IVDR and MHRA compliance, with comprehensive security features including CFR 21:11 audit compliance and HIPAA compatibility. The system supports ISO15189 compliance and has been successfully integrated into clinical laboratory workflows globally.
The PCR.AI CE-IVDR Strategic Advantage Platform is now available across Europe for both clinical laboratories and diagnostic manufacturers. The comprehensive offering includes the CE-IVDR and MHRA registered PCR.AI API, along with technical, regulatory, and implementation support services.
Proven clinical performance
The platform has demonstrated significant operational benefits in real-world settings. During the COVID-19 pandemic, King’s College Hospital successfully scaled their testing capacity from 15 samples per day to 1,100 COVID-19 samples daily – representing a 7,300% increase – whilst maintaining quality standards and ISO15189 compliance.
Dr Mark Zuckerman FRCPath MRCP, Head of Virology at NHS KCL, commented: “This is the best system we have seen that ensures the accuracy of our tests and improves our clinical diagnostic service.”
The universal compatibility of PCR.AI enables use with any assay on major thermocycler brands, eliminating the need for reprogramming when implementing new tests. This flexibility, combined with automated quality control protocols and comprehensive reporting capabilities, positions the platform as a transformative tool for modern molecular diagnostics.
- For more information, visit: www.diagnostics.ai
