DPCR analysis system enters the special approval process for innovative medical devices

Recently, this website has noticed that the “Chip Digital Polymerase Chain Reaction (DPCR) Analysis System” has entered the special approval process for innovative medical devices at the Center for Medical Device Evaluation (CMDE) of the State Food and Drug Administration. With its innovative features, DPCR can complement the high-throughput sequencing (NGS) platform and is expected to be one of the important platforms to support liquid biopsy.

数字PCR分析进入医疗器械审批 可与高通量测序优势互补

Digital PCR is one of the most exciting innovations in the field of PCR, and the birth of this technology has made absolute quantitative dreams a reality. Unlike traditional PCR, digital PCR is a new method for nucleic acid detection and quantification that directly detects the copy number of a target sequence. It does not rely on standard curves and reference samples and is therefore more sensitive, specific and accurate than traditional PCR.

Digital PCR technology has shown great advantages in the detection of extremely small nucleic acid samples, the detection of rare mutations in complex backgrounds, and the identification of small differences in expression levels.

数字PCR分析进入医疗器械审批 可与高通量测序优势互补

Principle of digital PCR

DPCR products receive special approval for innovative medical devices

Recently, this website has noticed that the “Chip Digital Polymerase Chain Reaction (DPCR) Analysis System” has entered the special approval process for innovative medical devices at the Center for Medical Device Evaluation (CMDE) of the State Food and Drug Administration. This means that this digital PCR product is the first to be included in the "green channel." In this way, we interviewed Dr. Wang Wei, CEO of Nanjing Keweisi Biotechnology Co., Ltd., and asked him to introduce the innovation of this technology.

数字PCR分析进入医疗器械审批 可与高通量测序优势互补

Dr. Wang Wei said: "First of all, the sensitivity is high. There are 20,000 micropores on each chip, which can form 20,000 independent PCR reaction systems with a detection sensitivity of 0.1%. Secondly, it is isolated from pollution. With the help of multi-color fluorescence system and The sealed chip, dPCR system can avoid the common DNA loss in contaminants and droplet systems. Finally, the instrument is easy to operate and equipped with intuitive and simple reading and analysis software."

“In November 2015, we signed a cooperation agreement with Therno Fisher to build a chip-based digital PCR system. One year later, based on Themo Fisher products, we applied for invention patents for core consumables for rapid localization and committed to building China. And the world's first digital PCR technology platform." Dr. Wang Wei recalled.

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