Genetic Signatures secures FDA clearance for gastrointestinal parasite detection kit

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Molecular diagnostics company Genetic Signatures (ASX:GSS) has announced that the US FDA has cleared its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow for marketing and sale in the US.

The kit has the broadest coverage of the FDA-cleared molecular tests and can identify eight of the most common and clinically relevant gastrointestinal parasites in a single test. This represents approximately 90 per cent of all gastrointestinal parasitic infections in the US. The kit is highly automated and is able to provide a result for all eight targets in approximately five hours.

The current practice for gastrointestinal parasite testing is a predominantly microscopic examination, which is time-consuming, labour-intensive, slow to provide a result, of variable sensitivity and frequently has poor patient compliance across multi-sample protocols. It is estimated there are approximately 65 million annual cases of parasitic gastrointestinal infections in the US, which result in approximately 5.5 million tests each year.

Genetic Signatures said it is well-prepared for the commercial launch of its kit. It has installed instruments and completed training at nine customer‑experience sites, which span a range of customer groups, including hospitals, health departments and corporate pathology providers, under a customer-experience program. It expects the first commercial sale of the kit in the US within 60 to 90 days of this FDA clearance once the appropriately packaged and labelled product is available and its pathology provider customers have completed their internal technology evaluation and approval process.

“We are very excited to have secured our first FDA clearance for a unique and highly differentiated molecular test based on our proprietary 3base technology,” said Neil Gunn, Interim CEO.

“This has been a key focus for the Company as the US is the largest single market for molecular diagnostics representing approximately 40% of the global market. We believe the unique configuration of our test combined with the significant operational efficiencies and potential impact on patient management will make this an attractive product for laboratories and pathology providers in the US.”