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BGI Receives CE Mark for NIFTY Noninvasive Prenatal Test on BGISEQ-500 Platform

BGI has received the CE mark for its NIFTY cell-free DNA-based noninvasive prenatal test kit for fetal chromosomal aneuploidies on the BGISEQ-500 sequencing platform, the company said last week.

The test obtained EU medical device CE certification, issued by the British Standards Institution (BSI).

The NIFTY test estimates the risk of a fetus having trisomy 21, trisomy 18, and trisomy 13, sex chromosomal disorders, and certain deletion syndromes. It works by analyzing cell-free DNA from maternal blood at 10 weeks of gestation.

The China Food and Drug Administration had also previously accredited both the NIFTY test and the BGISEQ platform.

"By being able to offer the NIFTY test on our own BGISEQ-500 platform, rather than relying on third party sequencing platforms, we are capable to develop our cost effectiveness and confirm total quality control of the entire testing procedure," Ryan Liu, Europe sales director for BGI Genomics, said in a statement.

BGI said that as of the end of 2017, the NIFTY test has been performed on more than 2.5 million samples international.