BGI Europe A/S, a wholly owned subsidiary of BGI Genomics, announced its NIFTY® non-invasive prenatal testing kit and software (CE-IVDD List B) were granted an extension under its existing CE-IVDD certification to include the DNBSEQ-G99 model to meet the European Union regulations for medical devices.
Credit: BGI Genomics
BGI Europe A/S, a wholly owned subsidiary of BGI Genomics, announced its NIFTY® non-invasive prenatal testing kit and software (CE-IVDD List B) were granted an extension under its existing CE-IVDD certification to include the DNBSEQ-G99 model to meet the European Union regulations for medical devices.
In January 2024, BGI Genomics unveiled the NIFTY® ultra-fast non-invasive prenatal genetic testing product, utilizing the innovative DNBSEQ-G99 platform. Designed for both small and medium throughput, this platform ensures top-notch testing performance and quality. It enables clinical laboratories to provide quicker and more accurate prenatal genetic testing results. This advancement is crucial for timely genetic counseling and further prenatal diagnosis, enhancing prenatal care options.
Key Features of the DNBSEQ-G99 Platform:
Speed: The DNBSEQ-G99 platform dramatically reduces sequencing time to just 3 hours, with the entire process from sample collection to report generation taking only 14 hours. This efficiency significantly reduces the anxious wait for expecting families.
Flexibility: It allows for the processing of varying sample sizes in a single run, accommodating a minimum of 12 samples. This flexibility helps in minimizing reagent waste and cutting costs.
Versatility: The platform supports various sequencing modes and is suitable for a wide range of tests, including pre-embryo transplantation chromosome testing and monogenic disease carrier screening.
Simplicity: Featuring a cassette flow cell and an innovative pre-injected reagent design, the DNBSEQ-G99 simplifies the sequencing process, making it user-friendly for operators.
BGI Genomics has been a pioneer in non-invasive prenatal genetic testing since 2010. NIFTY® has received medical device qualifications in various countries, including the United Kingdom, Australia, Saudi Arabia, Turkey, India, and Thailand. BGI Genomics continues to upgrade its prenatal and neonatal tests, contributing to better public health systems and outcomes.
Guided by the vision of “Omics for all,” BGI Genomics is dedicated to enhancing genetic testing technologies, thereby advancing global precision medicine and improving lives.
About BGI Genomics
BGI Genomics, headquartered in Shenzhen, China, is the world’s leading integrated solutions provider of precision medicine. To learn more about the NIFTY® Test – the world’s leading non-invasive prenatal test (NIPT), please see this webpage. In July 2017, as a subsidiary of BGI Group, BGI Genomics (300676.SZ) was officially listed on the Shenzhen Stock Exchange.