Salignostics Secures TGA Approval for Groundbreaking Saliva-Based Home Pregnancy Test
Salignostics, a leader in innovative saliva-based diagnostic solutions, proudly announces that its novel saliva-based home pregnancy test has achieved approval from Australia's Therapeutic Goods Administration (TGA) in partnership with our Australian sponsor SGG Solutions. This milestone, accomplished after a rigorous year-long regulatory process, marks a pivotal moment in the company’s journey to revolutionize the pregnancy test market.
With TGA approval, Salignostics is poised to enter the markets of Australia and New Zealand, offering consumers an accurate, easy-to-use, and non-invasive alternative for detecting pregnancy. This achievement aligns with the company’s mission to expand global distribution of its cutting-edge diagnostic products, solidifying its presence as a pioneer in the field.
Building on Global Success
This accomplishment follows the successful 2024 market penetration of Salistick, the world's first saliva-based pregnancy test, in leading pharmacy chains in the UK and Israel, including Boots, Superdrug, and Super-Pharm. In these two markets alone, Salistick has achieved over 500,000 units in sales and orders within its first year, demonstrating robust consumer demand and positioning Salignostics as a key player in the global diagnostics market. The approval by the TGA represents another critical step in Salignostics' global expansion strategy.
TGA: A Gateway to Global Expansion
The TGA is recognized as one of the world’s most stringent regulatory authorities, setting high standards for safety, quality, and performance. Securing TGA approval not only validates the efficacy of Salignostics’ saliva-based test but also serves as a gateway to pursuing additional regulatory approvals. The company is now gearing up to target the U.S. FDA market, with plans to advance this strategic initiative in 2025.
Unveiling the Market Potential
The global pregnancy test market is valued at approximately $2.1 billion in 2023 and is projected to grow at a compound annual rate of 7% through 2030. In Australia and New Zealand, the market for home pregnancy tests alone is estimated to reach $120 million by 2025, driven by rising healthcare awareness and demand for non-invasive solutions. Salignostics is uniquely positioned to capture this opportunity by introducing its saliva-based technology, which combines convenience, accuracy, and user-friendliness.
Transforming the Future of Home Diagnostics
"Achieving TGA approval is a testament to our dedication to innovation and quality," said Dr. Guy Krief, Co-founder and deputy CEO at Salignostics. "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."
Andrew Shostak, Managing Director of SGG Solutions, the Australian sponsor for Salignostics, commented, "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 partnerhship 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."
About Salignostics
Salignostics is at the forefront of saliva-based diagnostic innovation, offering groundbreaking solutions that enhance convenience, accuracy, and accessibility. Committed to advancing healthcare worldwide, the company is revolutionizing the way people approach diagnostics, one test at a time.
The global pregnancy testing market was valued at approximately $2.1 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of around 6.5% to 7% through 2030. This growth is driven by factors such as advancements in fertility and pregnancy testing technologies, rising demand for home testing solutions, and increasing awareness about early detection of pregnancy. Both Australia and New Zealand represent significant opportunities in this market, thanks to high demand for consumer-friendly, over-the-counter products.
Salignostics' successful approval of its novel saliva-based home pregnancy test by the Therapeutic Goods Administration (TGA) of Australia is a key step in expanding into these markets. With TGA approval in hand, Salignostics is well-positioned to tap into the growing market demand in both Australia and New Zealand, which have robust healthcare sectors and increasing consumer interest in accessible health diagnostics. Furthermore, this achievement sets the stage for the company to seek additional regulatory approvals, including from the U.S. FDA, with plans to pursue this milestone in 2025.
