Diagnostics.ai Unveils Transparent AI Platform for PCR Diagnostics

The platform was developed in response to the EU’s increasingly stringent requirements around algorithmic transparency, diagnostic reproducibility, and traceability.

Diagnostics.ai has launched the industry’s first fully transparent machine learning platform for clinical real-time PCR diagnostics.

The new platform, CE-marked under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), enables transparency, auditability, and regulatory compliance in molecular diagnostics.

The move comes as a result of the CE-IVDR compliance deadline, which was on May 26.

The CE-IVDR Strategic Advantage Platform allows clinical laboratories to see precisely how AI-generated PCR result analyzes are produced, a first in machine learning-driven molecular testing. 

Backed by more than 15 years of expertise and millions of successfully processed samples with over 99.9% documented accuracy, the platform redefines trust and performance in diagnostic AI.

The platform was developed in response to the EU’s increasingly stringent requirements around algorithmic transparency, diagnostic reproducibility, and traceability.

“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, Chief Executive Officer 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,” Aron added.

The transparent AI architecture is built on a “model-aware” framework that helps laboratories understand each AI-generated suggestion in real time.

The platform offers several key benefits, including transparent result attribution that shows exactly how each diagnostic outcome is generated, eliminating guesswork.

Real-time model monitoring helps laboratories track AI performance and detect drift, ensuring ongoing compliance with IVDR Article 72. Each test includes algorithm-level accountability with easy-to-audit reports for full traceability.

Additionally, clinician-ready explanations make results clear and accessible, supporting effective clinical communication and decision-making.

“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,” said Dr Brian Glenville, MD, Chairman of Diagnostics.ai.

Now available across Europe, the CE-IVDR Strategic Advantage Platform includes the CE-IVDR and MHRA-registered PCR.AI API along with technical, regulatory, and implementation support. It is designed for clinical laboratories and diagnostic manufacturers looking to enhance compliance while maintaining high performance. 

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