Two Domestic IVD Companies Obtained Innovation Approval

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Two Domestic IVD Companies Obtained Innovation Approval

NMPA granted two Innovation Approvals in February.

  • Suzhou Beikang: Pre-implantation chromosome aneuploidy detection kit (semiconductor sequencing)
  • Xiamen Feishuo: Human EGFR / KRAS / BRAF / HER2 / ALK / ROS1 gene mutation detection kit (semiconductor sequencing)

In the Approval Notice for the aneuploidy kit, NMPA mentions the product “establishes a method for detecting pre-implantation chromosomal abnormalities by using embryo blastocyst stage cells, and adopts single-cell expansion technology to improve the alignment, uniformity and coverage of sequencing results; The analysis model of ploidy detection data reduces the analysis bias between samples caused by amplification and shortens the detection cycle to one day.”

For the EGFR / KRAS / BRAF / HER2 / ALK / ROS1 kit, NMPA says the product “is based on a common PCR platform that combines specifically modified primers and RingCap loop-mediated amplification technology to detect mutant genes contained in DNA / RNA samples. Using specific modified primers for PCR amplification of the target sequence, meanwhile, using RingCap loop-mediated amplification technology to modify the end of the amplified product, linking the specific sequence ends, combined with a special PCR reaction program and the use of RingCap enzyme, Library construction of target sequences in sample DNA / RNA for high-throughput sequencing is achieved on common PCR platforms to achieve accurate detection of multi-gene and multi-target mutations.”

For the review of 2019 Innovative Approval, Priority Review & Emergency Approval, please click HERE.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.