Salignostics has announced that its saliva-based pregnancy test, Salistick, has received approval from Australia's Therapeutic Goods Administration (TGA), allowing the company to introduce its innovative technology to consumers in Australia and New Zealand. This regulatory milestone follows a comprehensive year-long process and builds upon Salistick's successful launches in the UK and Israel in 2024, where it has already sold or received orders for over 500,000 units within its first year of availability. The TGA certification is viewed as a stepping stone for further regulatory approvals, including plans for U.S. FDA clearance in 2025.
The approval is particularly significant given the projected growth of the home pregnancy test market in Australia and New Zealand, estimated to reach $120 million by 2025. This reflects a broader global trend, with the worldwide pregnancy test market valued at approximately $2.1 billion in 2023 and expected to grow at a compound annual rate of 7% through 2030. Salistick's technology represents a paradigm shift in pregnancy testing by utilizing 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, user-friendly alternative to traditional urine-based tests.
Dr. Guy Krief, Co-founder and Deputy CEO of Salignostics, emphasized the significance of this approval, stating that achieving TGA approval is a testament to the company's dedication to innovation and quality. Andrew Shostak, Managing Director of SGG Solutions, Salignostics' Australian partner, expressed enthusiasm about the product's potential impact, noting that this cutting-edge product is poised to transform the pregnancy testing market, setting a new benchmark for both convenience and precision. The implications of this approval extend beyond pregnancy testing, as Salignostics has demonstrated expertise in saliva-based diagnostics with solutions for COVID-19 testing and plans to expand its portfolio to address other health conditions, including streptococcus, sexually transmitted diseases, and cardiac risk indicators.
This diversification highlights the broader potential of saliva-based diagnostic technologies in revolutionizing home health testing across various medical fields. As Salignostics prepares to enter the Australian and New Zealand markets with Salistick, the company is positioned at the forefront of a significant shift in home diagnostics. The TGA approval not only validates the technology's reliability and safety but also opens doors for further global expansion and innovation in non-invasive testing methods. The introduction of Salistick to these new markets represents a critical step towards more accessible, user-friendly, and accurate home diagnostic solutions, potentially playing a pivotal role in shaping the future of personal healthcare management and early disease detection as demand for non-invasive and convenient health testing continues to grow.
