FDA Clearance for EasyScreenTM Gastrointestinal Parasite Detection Kit

Genetic Signatures Limited (ASX: $GSS) has received clearance from the US Food & Drug Administration (FDA) for its EasyScreenTM Gastrointestinal Parasite Detection Kit and GS1 automated workflow. The kit, with the broadest coverage of FDA cleared molecular tests, can identify 8 common and clinically relevant gastrointestinal parasites in a single test, representing approximately 90% of all gastrointestinal parasitic infections in the US. The highly automated kit is capable of providing results for all 8 targets in approximately 5 hours.

Executive Commentary on FDA Clearance

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. 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.

Summary of FDA Clearance and Outlook

Genetic Signatures Limited has achieved a significant milestone with the FDA clearance for its EasyScreenTM Gastrointestinal Parasite Detection Kit, positioning the company for a commercial launch in the US. The kit's ability to identify 8 common gastrointestinal parasites in a single test, along with its high level of automation and rapid results, presents a compelling solution for the US market. With an estimated 65 million annual cases of parasitic gastrointestinal infections in the US, the commercial potential for this kit is substantial. The company has already completed training at customer-experience sites and expects the first commercial sale of the kit in the US within 60-90 days of the clearance. Genetic Signatures is well-prepared to capitalize on the opportunities in the US market, leveraging its proprietary 3base technology to address the growing demand for infectious disease screening.