Genetic Signatures' Quarterly Performance and Regulatory Approvals

Genetic Signatures Limited (ASX: $GSS) reported unaudited sales of $1.7 million for the third quarter of FY2024. The company's sales were impacted by seasonally reduced sales of the EasyScreen TM Respiratory Pathogen Detection Kit due to modifications under review by the Australian Therapeutic Goods Administration (TGA). Genetic Signatures ended the quarter with a cash balance of $20.3 million, including proceeds from a completed capital raise of approximately $15.9 million in January 2024.

CEO's Perspective on Recent Developments

We were very pleased to be advised that the Australian TGA has approved the changes to the design of our EasyScreenTM Respiratory Pathogen Detection Kit. We are now able to ship this redesigned kit immediately to our customers as they prepare for the Australian influenza season. We have also been working on a comprehensive response to the latest submission to the US FDA in relation to the 510(k) application for our EasyScreen'TM Gastrointestinal Parasite Detection Kit and we continue our preparations for launching this in the US in the second half of this calendar year.

Outlook and Future Plans

Genetic Signatures recorded sales of $1.7 million for the third quarter of FY2024, with approximately 16% of sales from international markets. The company anticipates FDA clearance for its EasyScreenTM Gastrointestinal Parasite Detection Kit, which represents a significant commercial opportunity in the US. Genetic Signatures is well-advanced in its preparations for the anticipated commercial launch once cleared by the FDA. The company also has a solid R&D program with over 5 new product groupings at various stages of development and is expecting to recommence non-critical expenditure on these programs shortly after 510(k) clearance. With a cash balance of $20.3 million, Genetic Signatures is strategically positioned to pursue its corporate strategy and capitalize on its innovative molecular diagnostics technology.