Diagnostics.ai has launched PCR.AI, a groundbreaking, fully-transparent machine learning platform for clinical real-time PCR diagnostics, coinciding with the May 26th CE-IVDR compliance deadline. This platform is presented as the industry’s first to demonstrate precisely how each diagnostic result is achieved, a significant step forward for transparency in molecular-testing machine learning. The technology is supported by over 15 years of experience and has processed millions of samples with a proven accuracy exceeding 99.9%.

The PCR.AI CE-IVDR Strategic Advantage Platform is Diagnostics.ai's response to the stringent new EU regulations under the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations mandate higher standards for diagnostic accuracy, reproducibility, and notably, algorithm transparency. Aron Cohen, Chief Executive Officer of Diagnostics.ai, emphasized this, stating, “While most diagnostic algorithms remain an impenetrable ‘black box,’ the PCR.AI API was engineered with transparency included from the ground up. 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.”

The platform's transparent AI architecture is built around a pioneering “model-aware” system, which enables laboratories to comprehend the suggestions made by the AI. Key innovations and highlighted benefits include: Transparent Result Attribution, which directly shows how and why a result was achieved, moving beyond post-hoc interpretations; Real-Time Model Monitoring, allowing labs to track model performance and detect drift in real time, fulfilling IVDR Article 72 requirements; Per-Test Algorithm Accountability, providing easy-to-understand per-test reports for comprehensive auditability; and Clinician-Ready Explanation Generation, which furnishes laboratory professionals and clinicians with clear, auditable explanations of diagnostic outcomes to support informed clinical communication.

Dr. Brian Glenville MD, Chairman of Diagnostics.ai, commented on the platform's impact: “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.”

The PCR.AI CE-IVDR Strategic Advantage Platform, which includes the CE-IVDR and MHRA registered PCR.AI AI API, along with technical, regulatory, and implementation support, is now available across Europe. It caters to both clinical laboratories and diagnostic manufacturers, empowering them to meet and surpass regulatory obligations while fostering deeper confidence in diagnostic results. PCR.AI is already successfully utilized in the U.S., U.K., and other countries, trusted by leading laboratories for its dependable and transparent diagnostic performance.

About Diagnostics.ai: Diagnostics.ai is an established leader in AI-powered PCR analysis, boasting over 15 years of experience serving clinical laboratories globally. The company has processed millions of samples with documented >99.9% accuracy and maintains full CE-IVDR and MHRA compliance. PCR.AI's transparent machine learning platform aims to transform laboratory efficiency while ensuring regulatory adherence.