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Highlight | TargetingOne 5-color Digital PCR Analyzer Receives Medical Device Approval

release date:2021-11-30

Recently, TargetingOne 5-color digital PCR biochip analyzer has officially received the medical device approval. The approval of this high-performance product, the world's first 5-color microdrop digital PCR analyzer based on flow detection gained clinical access, providing a faster, easier and more efficient analysis tool for clinical molecular diagnostics, which is an important breakthrough in the field of digital PCR and an important progress in the field of molecular diagnostics.

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As an emerging nucleic acid detection method with outstanding advantages such as absolute quantification and single-molecule sensitivity, digital PCR is becoming a key technology in the field of precision medicine, and top international life science and medical diagnostic companies are competing to invest in research and development.

The technical path of digital PCR mainly includes two key aspects: reaction system partitioning and fluorescence detection. The reaction system partitioning can be divided into two ways: microdrop and microwell, and the detection method can be divided into two ways: flow and imaging detection. Among them, the microdrop method has the advantages of low cost of consumables, good uniformity of microdrop size, and high sample throughput; the flow detection has the advantages of high sensitivity of fluorescence detection, high signal-to-noise ratio, strong multi-indicator detection ability, and the number of droplets is not easily limited. The digital PCR system based on the technical route of combining microdroplet and flow detection has better performance in several key performance indicators of digital PCR.

The rapid development of molecular diagnostics has created an increasingly urgent need for parallel testing of multiple indicators. The first laser quasi-confocal optical path is used by TargetingOne to efficiently excite droplet fluorescence, complete more fluorescence channels within the spectral bandwidth, and eliminate fluorescence crosstalk between channels using a patented algorithm, thus achieving simultaneous high-speed detection of 5-color fluorescence channels. This is the first time in the world to achieve clinical access to a 5-color digital PCR analyzer, leading the international industry in the precise detection of multiple indicators for clinical molecular diagnostics.


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Technical Specification for TD-2 Digital PCR Platform

Through independent innovation, TargetingOne is the head enterprise of digital PCR mastering the core technology based on flow microdroplet. TD-2 digital PCR platform, which performs better in several key aspects.

Fully enclosed microdrop PCR amplification and flow-through detection: multiple anti-pollution design, high sensitivity of fluorescence detection, good signal-to-noise ratio, strong multi-indicator detection capability, and the number of droplets is not easily restricted.

World's first quasi-confocal light path 5-color fluorescence synchronous detection: using the first laser quasi-confocal light path to efficiently excite droplet fluorescence, complete more fluorescence channel detection within the spectral bandwidth, patented algorithm to eliminate fluorescence crosstalk between channels, to achieve 5-color fluorescence channel synchronous high-speed detection.

New high-dimensional watershed classification algorithm: five-color fluorescence channels are automatically classified, simplifying the fluorescence classification process of multiple indicator systems, with accurate and reliable classification results and convenient and intuitive viewing of analysis results.


Typical Applications for TD-2 Digital PCR Platform

Based on the TD-2 microdrop digital PCR system, TargetingOne has developed several supporting kits in the fields of oncology, infectious diseases, tumor concomitant diagnosis, and birth defects, which have entered multi-center clinical trials one after another, providing a complete molecular diagnostic solution for clinical applications. For example, the reagents based on the core genetic tests, such as the 7-10 gene test for lung cancer, the 5-gene test for thyroid cancer, the 5 items for pneumonia, and the SMA (including SMN1 and SMN2) kits, can more accurately meet clinical testing needs.


Meanwhile, the TD-2 microdrop digital PCR system, as an open platform, can meet the development needs of users for self-developed in vitro diagnostic reagents. In response to the rapid development of molecular diagnostics, TargetingOne will continue to cultivate the digital PCR field, continue product innovation, improve scientific cooperation and technical services, and make contributions to in vitro diagnostics in China and around the world!

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