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Diagnostics.AI launches industry’s first CE-IVDR certified transparent AI platform for molecular diagnostics as regulatory deadlines take fffect

Diagnostics.AI has launched the industry's first fully-transparent machine learning platform for clinical real-time PCR diagnostics, delivering algorithmic transparency and per-test auditability. The platform is CE-IVDR certified and backed by over 15 years of experience and millions of successfully processed samples.

Sourcediagnostics.ai ltd·TypeNews article·DateMay 29, 2025

Trust clinical COVID-19 signs over a negative RT-PCR test

A Rutgers study found that hospital patients with repeated negative RT-PCR tests but exhibiting COVID-19 signs and/or symptoms were half as likely to receive treatment as those who tested positive. The study suggests that clinicians should not solely rely on RT-PCR tests for COVID-19 diagnosis.

SourceRutgers University·JournalBMC Infectious Diseases·TypeObservational study·DateFeb 14, 2022

Development of high-speed nanoPCR technology for point-of-care diagnosis of COVID-19

Developed by a team of researchers, the nanoPCR technology uses hybrid nanomaterials to detect viral RNA in under 11 minutes while maintaining high accuracy. The technique has been tested with 150 patients, showing zero false negatives and positives, and demonstrates its potential for rapid, decentralized point-of-care diagnosis.

SourceInstitute for Basic Science·JournalNature Biomedical Engineering·DateDec 8, 2020

Low sensitivity of clinical signatures

New research found that many published clinical genomic signatures have high specificity but very low sensitivity, making them inadequate for most clinical applications. The study suggests that a rigorous approach to evaluating signature quality is necessary to improve the accuracy of sequence-based diagnostics.

SourceBMC (BioMed Central)·JournalAnnals of Clinical Microbiology and Antimicrobials·DateSep 24, 2008