FDA Clearance For Gastrointestinal Parasite Detection Kit

MELBOURNE, Australia, June 4, 2024 /PRNewswire/ -- Genetic Signatures Limited [ASX:GSS] ("GSS" or the "Company"), a global molecular diagnostics company announces that the US Food & Drug Administration ("FDA") has cleared the Company's EasyScreen™ Gastrointestinal Parasite Detection Kit and GS1 automated workflow[1] for marketing and sale in the US.

Genetic Signatures’ EasyScreen™ Gastrointestinal Parasite Detection Kit has the broadest coverage of the FDA cleared molecular tests and is able to identify 8 of the most common and clinically relevant gastrointestinal parasites in a single test, representing approximately 90%[2] of all gastrointestinal Parasitic infections in the US. Genetic Signatures’ EasyScreen™ Gastrointestinal Parasite Detection Kit is highly automated and is able to provide a result for all 8 targets in approximately 5 hours.

The current practice for gastrointestinal parasite testing is predominantly microscopic examination using O&P[3] testing, that 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 O&P tests each year.

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