Salignostics has secured approval from Australia's Therapeutic Goods Administration for its saliva-based pregnancy test, Salistick, enabling the company to introduce its innovative technology to consumers in Australia and New Zealand. This regulatory milestone follows a comprehensive year-long process that validated the safety, quality, and efficacy of the product. The TGA certification is expected to facilitate further regulatory approvals, including plans for U.S. FDA clearance in 2025.
The home pregnancy test market in Australia and New Zealand is projected to reach $120 million by 2025, reflecting growing consumer demand for non-invasive, user-friendly diagnostic tools. Globally, the pregnancy test market is valued at approximately $2.1 billion in 2023, with a compound annual growth rate of 7% expected through 2030. Salistick has already demonstrated strong market traction since its launch in the UK and Israel in 2024, reaching over 500,000 units sold and ordered within its first year with availability in major pharmacy chains such as Boots, Superdrug, and Super-Pharm.
Salistick's technology utilizes saliva, which contains over 5,000 identified proteins, many of which are also found in blood. By accurately detecting the pregnancy hormone (β-hCG) in saliva, Salistick offers a non-invasive and convenient alternative to traditional urine-based pregnancy tests. Dr. Guy Krief, Co-founder and Deputy CEO of Salignostics, emphasized the significance of this approval, stating that achieving TGA approval builds on the momentum of Salistick's success in the UK and Israeli markets and brings the company closer to making accurate and user-friendly diagnostics accessible to more people worldwide.
Andrew Shostak, Managing Director of SGG Solutions, the Australian sponsor for Salistick, expressed enthusiasm about the product's potential impact, noting that this achievement represents a major milestone for the Australian and New Zealand healthcare markets by offering women and families more accessible, accurate, and reliable testing options. The TGA approval for Salistick represents a significant step forward in home diagnostics, potentially leading to earlier detection of pregnancies and improved access to prenatal care through more user-friendly testing methods.
Salignostics' success extends beyond pregnancy testing, with the company having 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. As the company continues to expand its global presence and develop new saliva-based diagnostic solutions, the healthcare industry may see a shift toward more accessible and convenient testing methods with far-reaching implications for public health, potentially leading to improved health outcomes and increased patient engagement in preventive care.
