NIFTY Test Receives Australia's Therapeutic Goods Administration Approval
2023-06-14
BGI Genomics, a world-leading provider of advanced genetic testing solutions, is proud to announce that its proprietary non-invasive prenatal testing (NIPT) product, the Detection Kit for Non-invasive Fetal Trisomy (T21, T18, T13) Test (NIFTY), utilizing the innovative Combinatorial Probe-Anchor Synthesis Sequencing Method and NIFTY software, has been granted the listing in the Australian Register of Therapeutic Goods (ARTG) from the regulatory authority Therapeutic Goods Administration (TGA).
The ARTG listing is an endorsement from the TGA, Australia's regulatory authority for therapeutic goods, affirming the Detection Kit's compliance with the highest quality, safety, effectiveness, and accuracy standards. The approval is a testament to the tireless efforts and dedication of our research and development team.
The Detection Kit for NIFTY Test revolutionizes prenatal testing by offering a non-invasive and highly accurate method to detect chromosomal abnormalities in fetuses. With the Combinatorial Probe-Anchor Synthesis Sequencing Method, the kit provides healthcare professionals and expecting parents with crucial insights into the presence of trisomy conditions, including Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), and Trisomy 13 (Patau syndrome).
In addition to the Combinatorial Probe-Anchor Synthesis Sequencing Method, the Detection Kit leverages the power of NIFTY software, a sophisticated analytical tool designed to enhance testing accuracy and efficiency. The TGA approval received by NIFTY software reinforces its credibility and indispensable role in delivering reliable results to medical professionals.
"We are proud to offer healthcare providers and expecting parents a safe, non-invasive, and accurate solution for prenatal screening. This milestone achievement reflects our commitment to delivering cutting-edge genetic testing solutions that benefit healthcare professionals and expecting parents across Australia,” said Mingyu Tian, General Manager of BGI Health (AU) Company Pty Ltd, an Australian subsidiary of BGI Genomics. “As a global leader in genomics and precision medicine, BGI Genomics has a proven track record of delivering cutting-edge solutions that have positively impacted healthcare systems worldwide. With our TGA-approved NIPT product, we are excited to contribute to advancing prenatal care in Australia by offering Australians access to world-class genetic testing services for a healthier future.”
For more information about the Detection Kit for Non-invasive Fetal Trisomy (T21, T18, T13) Test or to inquire about partnering opportunities, please contact BGI Genomics – Oceania at oceaniasales@bgi.com.
About BGI Genomics
BGI Genomics, headquartered in Shenzhen, China, is the world's leading integrated solutions provider of precision medicine. Our services cover more than 100 countries and regions, involving more than 2,300 medical institutions. In July 2017, as a subsidiary of BGI Group, BGI Genomics (300676.SZ) was officially listed on the Shenzhen Stock Exchange.