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Salignostics Secures TGA Approval for Saliva-Based Home Pregnancy Test

News provided by news direct2024-12-17

--News Direct--

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.

“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. We are excited to expand our footprint and continue breaking barriers in home testing solutions,” said Dr. Guy Krief, Co-founder and Deputy CEO of Salignostics.

The home pregnancy test market in Australia and New Zealand is estimated 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% projected through 2030.

“We are thrilled to support Salignostics in securing TGA approval for their innovative home diagnostics product. 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. As committed long-term partners, we look forward to deepening our partnership with Salignostics, supporting their global expansion, and helping them make a meaningful, lasting impact on healthcare worldwide. This cutting-edge product is poised to transform the pregnancy testing market, setting a new benchmark for both convenience and precision,” said Andrew Shostak, Managing Director of SGG Solutions.

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.

About Salignostics

Founded in 2016, Salignostics is led by a team of postdocs from the Hebrew University of Jerusalem. The team, with extensive experience in saliva research, includes world-renowned researcher Prof. Aharon Palmon, Vice President for Research and Development at the Hebrew University; Dr. Omer Deutsch, CEO of the company; Dr. Guy Krief, Deputy CEO; Dr. Raluka Cohen, Scientific Director; and Dr. Yoav Neuman, Senior Researcher.

After years of scientific exploration in the field of saliva, the founders began commercializing their accumulated intellectual property to develop user-friendly products for the accurate identification of various diseases and physiological conditions. In early 2022, Salignostics secured $8 million in capital in round A funding from private investors and is currently raising additional capital to support product sales in Israel and international markets.

About SGG Solutions

SGG Solutions is a leading international medical distribution company, specializing in the import, export, and implementation of advanced medical technologies.

Headquartered in Melbourne, Australia, SGG Solutions has extensive expertise and a strong presence in both local and international markets. With a broad network of connections at the government and corporate levels across the Southeast Asia region, the company is well-positioned to deliver innovative healthcare solutions worldwide.