Sonio Diagnostics has been CE marked since May 26, 2021!
Sonio Diagnostics has achieved its first CE class I marking by testing the performance of its algorithm using a database of 251 cases of precisely phenotyped postmortem examinations from a specialized center in France. This database covered 96 of the 294 (32.65%) syndromes equivalent to 79% of their overall prevalence in the Sonio thesaurus.
Strategies for clinical validation and results associated
During this first validation Sonio was tested using two different strategies:
(i) processing the whole signs (full phenotype) of each case at once as input. It achieved a good diagnosis in at least one of the first 7 diagnoses (top-7) for 96.7% of the cases (202/209). Meanwhile, the accuracy was at 91.9% for the top-5 and 87.1% top-3 outputs.
The second (ii) strategy consisted in assessing a “1-by-1” model, providing the anomalies sequentially prompted by the system, trying to mimic the use in a real life clinical setting. The correct diagnosis was within the top-7, top-5 and top-3 of Sonio’s output in 72.4%, 69.3% and 63.1%.
Case of inaccurate diagnosis
In case of diagnosis discordance, an adjudication committee of experts was called to resolve. The committee discarded 42 cases considered they were not amenable to ultrasound based diagnosis. Sonio failed to make the diagnosis only on 7/209 cases.
Sonio has developed an effective and robust real-time diagnostic decision support system for healthcare practitioners involved in prenatal diagnosis that is likely to improve the quality of their work as well as provide continuous medical training. We believe that the confidence gained by the physician could also improve the patient-physician interaction.
To learn more about Sonio’s clinical validation, you can click here.