Salignostics Secures TGA Approval for Saliva-Based Home Pregnancy Test

Salignostics, a leader in innovative saliva-based diagnostic solutions, proudly announces that its revolutionary saliva-based pregnancy test, Salistick, has received approval from Australia’s Therapeutic Goods Administration (TGA). This achievement marks a pivotal step forward for Salignostics, allowing the company to bring its cutting-edge technology to consumers in Australia and New Zealand. Partnering with SGG Solutions, the Australian sponsor for the product, Salignostics is poised to redefine pregnancy testing with its non-invasive, accurate, and user-friendly solution. The TGA approval follows a rigorous year-long regulatory process, reinforcing the safety, quality, and performance of Salistick. Recognized as one of the most stringent regulatory bodies globally, the TGA certification represents a gateway to further regulatory approvals, including plans to pursue U.S. FDA clearance in 2025. Building on the success of its 2024 launches in the UK and Israel, Salistick has already demonstrated strong market demand. The product has achieved a milestone of more than 500,000 units sold and ordered within its first year, supported by availability in major pharmacy chains such as Boots, Superdrug, and Super-Pharm. Salistick’s groundbreaking technology utilizes saliva, which contains over 5,000 identified proteins, many of which overlap with those found in blood. By accurately detecting the pregnancy hormone (β-hCG) in saliva, Salistick transforms the testing experience, enabling easy, non-invasive pregnancy detection from the comfort of home. Salignostics’ success in saliva-based diagnostics extends beyond Salistick. The company has also developed saliva-based testing solutions for COVID-19 and plans to expand its portfolio to address additional health conditions, including streptococcus, sexually transmitted diseases, and cardiac risk indicators. With TGA approval now secured, Salignostics is taking a critical step toward transforming the future of home diagnostics, delivering on its promise of advancing healthcare worldwide.