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FindGene Noninvasive Prenatal Screening Kit Gets Approval from Chinese Regulators

NEW YORK – FindGene Clinical Laboratories of China said last week that the country's National Medical Products Administration (NMPA) has approved its noninvasive prenatal screening test kit for in vitro diagnostic use.

The sequencing-based test screens for fetal trisomies 21, 18, and 13 using cell-free DNA from maternal blood. It relies on reversible terminator technology optimized by FindGene, which the company said provides "unprecedented accuracy."

FindGene said three clinical centers have validated the test in a prospective clinical trial involving more than 10,000 participants and found that it detected all trisomies present. According to the company, this was the first prospective trial of an NIPT in China, whereas past test approvals were based on retrospective trials.

"In recognizing the scientific merits of this work, NMPA is approving it as the first labeled NIPS service appropriate for screening virtually all pregnancies," the company wrote.

FindGene, headquartered in Shanghai, was founded in 2012 and has expertise in next-generation sequencing and mass spectrometry. It has been providing clinical laboratory services, including NIPT and inherited disease screening, and recently launched its first companion diagnostic test panel for oncology.