Genetic Signatures completes recruitment in pivotal clinical trial

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Molecular diagnostics company Genetic Signatures (ASX:GSS) has completed recruitment for the clinical trial of its 3base EasyScreen Enteric Protozoan Diagnostic Kit in the US.

The company said gastrointestinal parasites are a significant healthcare burden in the US with more than 350 million cases of acute gastrointestinal infections reported annually. Globally, protozoan infections are among the leading contributors to the diarrhoeal disease load and the leading cause of mortality of children under five years old.

Rapid and accurate identification of pathogenic parasites is critical to providing appropriate patient management.

Genetic Signatures said its technology enables the rapid and accurate detection of up to eight species of clinically relevant gastrointestinal parasites with results quickly available. 

The company said that once the trial is completed it anticipates an FDA 510(k) application will be submitted in late 2022.