In a significant development for the home diagnostics industry, Salignostics has secured approval from Australia’s Therapeutic Goods Administration (TGA) for its saliva-based pregnancy test, Salistick. This milestone achievement paves the way for the company to introduce its innovative technology to consumers in Australia and New Zealand, potentially transforming the landscape of home pregnancy testing.
The TGA approval comes after a comprehensive year-long regulatory process, underscoring the safety, quality, and efficacy of Salistick. Known for its stringent standards, the TGA certification is expected to facilitate further regulatory approvals, including plans for U.S. FDA clearance in 2025.
Salistick has already demonstrated strong market traction since its launch in the UK and Israel in 2024. The product has reached an impressive milestone of over 500,000 units sold and ordered within its first year, with availability in major pharmacy chains such as Boots, Superdrug, and Super-Pharm.
Dr. Guy Krief, Co-founder and Deputy CEO of Salignostics, emphasized the significance of this approval, stating, ‘Achieving TGA approval is a testament to our dedication to innovation and quality. This milestone builds on the momentum of Salistick’s success in the UK and Israeli markets, bringing us closer to making accurate and user-friendly diagnostics accessible to more people worldwide.’
The home pregnancy test market in Australia and New Zealand is projected to reach $120 million by 2025, reflecting a 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’s groundbreaking 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.
Andrew Shostak, Managing Director of SGG Solutions, the Australian sponsor for Salistick, expressed enthusiasm about the product’s potential impact: ‘This achievement represents a major milestone for the Australian and New Zealand healthcare markets, offering women and families more accessible, accurate, and reliable testing options.’
Salignostics’ success extends beyond pregnancy testing. 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.
The TGA approval for Salistick represents a significant step forward in the field of home diagnostics. By offering a more user-friendly and non-invasive option for pregnancy testing, Salignostics is poised to make a substantial impact on women’s health and family planning. The company’s innovative approach to diagnostics could potentially lead to earlier detection of pregnancies and improved access to prenatal care.
As Salignostics continues to expand its global presence and develop new saliva-based diagnostic solutions, the healthcare industry may see a shift towards more accessible and convenient testing methods. This could have far-reaching implications for public health, potentially leading to improved health outcomes and increased patient engagement in preventive care.
With its innovative technology and growing market presence, Salignostics is well-positioned to play a significant role in shaping the future of home diagnostics. As the company pursues further regulatory approvals and expands its product portfolio, it may continue to break new ground in the field of non-invasive diagnostic solutions.
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