Sinogene Medical Launches Industry-First Integrated Platform for Single-Molecule Nucleic Acid and Immunoassay Enabled by Proprietary Biochips

On October 27, 2022, Shenzhen CAS-Envision Medical Technology Co., Ltd. ("CAS-Envision") released the first complete bioinformatics mining product system made in China at the 19th China International Exhibition for Laboratory Medicine, In Vitro Diagnostics, and Blood Transfusion Equipment and Reagents (CACLP) held in Nanchang.

The product is manufactured byFully Integrated Digital PCR System for Molecular Nucleic Acid Applications: Xin Qi Ji^®JX-P Series and Single-Molecule Immunoassay System for High-Sensitivity Protein Detection - Core Abandon^®JX-E SeriesComposed of, this system showcases the nearly decade-long original innovations and engineering R&D achievements of CAS-Envision and its partner, the Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences.

At this exhibition, Dr. Tianzhun Wu, CEO of CAS-Envision and researcher at Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, presented two newly released instruments: "Based on Core Abandonment.^®"Fully Automatic Digital PCR Instrument with JX-8P Chip" and "Based on芯弃疾^®"JX-1E Chip Single-Molecule Immunoassay Analyzer"

These two instruments deeply integrate their patented semiconductor technology with biomedicine detection technology.Adopting the same system architecture, high-sensitivity detection applications are developed for both molecular and immune markets, with some performance indicators reaching internationally advanced levels.At the same time, CAS-Envision is also the first company in the industry to simultaneously focus on single-molecule nucleic acid and protein ultra-sensitive detection. It will further develop chip-based and integrated solutions in the future to achieve low-cost, ultra-sensitive, and fully automatic detection of single molecules/single cells (nucleic acids/proteins/cells).

Dr. Tianzhun Wu has over 15 years of experience in the semiconductor and biomedical fields, consistently focusing on cross-disciplinary innovation between semiconductor technology and medical devices. He has led the development of core technologies for a series of BioMEMS and microfluidic chips, holds more than 100 domestic and international patents, and has managed or regularly overseen various research and industrial projects totaling 180 million yuan. He introduced how digital semiconductor technology can provide new perspectives and solutions for IVD testing products.

Dr. Tianzhun Wu Delivered an Excellent Presentation

Subsequently, Ren Haofan, Marketing Director of CAS-Envision, and Zhang Lei, R&D Director, respectively introduced the applications and layout of the fully automatic digital PCR instrument and the single-molecule immunoassay analyzer in scientific research/clinical settings, and showcased the latest project progress. In the future, the company will focus on the upstream market, providing core solutions for high-end equipment and chips to support multiple related research application fields such as liquid biopsy for tumors, pathogen detection, and prenatal diagnosis. Currently, these two products have already initiated collaborations in scientific research and clinical aspects with renowned hospitals and clinical research institutions in China, and have received validation from key customers in the IVD field. In the future, they will be able to provide OEM/ODM technical services externally.

This press conference not only attracted the attention of many practitioners and upstream and downstream customers, but also several hospitals and medical device distributors expressed clear intentions to cooperate with CAS-Envision on-site.

CAS-Envision, a high-tech medical device enterprise with a primary stake held by the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences, has profound expertise in the biochip + medical field. It is committed to developing an operating system that enables interconnectivity between semiconductors and biomedicine. The company focuses on creating Class III high-end medical devices based on cross-disciplinary innovative semiconductor chips with ultra-sensitive sensing capabilities, including digital PCR/single-molecule immunoassay systems. Additionally, the company has established a subsidiary, Shenzhen Bowang Chuxin Semiconductor Technology Co., Ltd., aiming to provide diverse and advanced medical semiconductor chip solutions for niche sectors of high-end medical devices, filling the upstream gap in China's medical chip industry.

CAS-Envision founder Wu Tianzhun told VCBeat that this time, the Xinqiji^®The core technology of the product series is the result of nearly a decade of technical accumulation and multidisciplinary integration by CAS-Envision and the Chinese Academy of Sciences team, truly possessing full independent intellectual property rights.

As of now, CAS-Envision's product-related technologies have nearly 30 patents applied for and granted. By the end of 2023, the company is expected to complete applications for more than 20 domestic invention patents in China and 5 PCT patents globally.

Core Abandonment^®-JX-8P Fully Automatic Digital PCR Instrument

Chip Abandonment Syndrome^®JX-1E Single-Molecule Immunoassay Analyzer

Compared with previous medical testing products and high-precision bioinformatics mining products, CAS-Envision^®The biggest advantage of the product series is its simplicity and versatility.

Currently, 80% of the demand for bioinformatics mining and medical testing is concentrated at the cellular, protein, and nucleic acid molecular levels. If relevant departments want to possess the above-mentioned testing capabilities, they need to purchase imported flow cytometers, electrochemiluminescence equipment, digital PCR/sequencers, as well as related test kits, and also need to train the operators. In this scenario, the department needs to spend tens of millions of yuan.

And the Chip Abandonment Disease released this time^®The product series can beProducts for universal and highly sensitive detection at the cellular, protein, and nucleic acid levels, capable of meeting testing scenarios with low-abundance, rare samples, and 3~5μL sample volumes, saving users nearly 80% of comprehensive costs.

Moreover, the sample volume involved in testing has changed from hundreds of μL in the past to just a few μL now. Consequently, at the microscopic scale, the movement characteristics between molecules have altered, reducing the time required for immunological tests from at least nearly 20 minutes to half of that, significantly enhancing the precision and efficiency of the detection.

At the operational level, CAS-Envision^®The series of products adopts a convenient one-button operation mode, realizing "sample in, results out" instant testing. For users, CoreAbandon^®The series of products save about 80% of the后期操作、维护及保养成本 compared to products using traditional models, not only reducing the difficulty of operation and enhancing ease of use, but also cutting comprehensive costs, with significant results in cost reduction, efficiency increase, and quality improvement.

Regarding future plans, Wu Tianzhun stated that, against the backdrop of national encouragement for medical device innovation and driven by favorable trends such as precision medicine and personalized medication, CAS-Envision...^®The market for the series of products will continue to expand. Xin Qi Ji^®Bioinformatics Mining System Product, with the advantages of being universal, innovative, accurate, fast, and low-cost, promotes the development of the trillion-dollar medical testing market.

He also pointed out, Core Abandonment Syndrome^®The market for the series of products is no longer a single "stock" or "incremental" market, but rather one that, on the basis of enhancing "stock," further explores "incremental" space. This will involve deeper market development and product innovation in various subfields of medical testing and even in similar subfields such as CGT. Moreover, leveraging the "medical-engineering collaboration" model clearly outlined in the national "14th Five-Year Plan," along with a series of favorable policies from the NMPA and the National Healthcare Security Administration this year, we believe that original innovations like芯弃疾, developed over a decade of dedication, will thrive.^®The future of the product series will be unlimited.

In the following commercialization process, CAS-Envision will be based on the current CoreAbandon.^®The JX-P/JX-E series of products, with their deep cultivation and insight into the market, further enhance the family-oriented commercial product line.^®The chipization and automation of JX-C aim to address the fragmented testing needs of households that centralized PCR laboratories struggle to cover, ultimately achieving a "high sensitivity + low cost + simplicity" layout for early screening and precise diagnosis of serious diseases.

In addition to the release of significant products, at this exhibition, the Molecular Diagnostics Joint Laboratory of Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences—Shenzhen CAS-Envision Medical Technology Co., Ltd., as well as the Corporate Joint Innovation Center of the Pilot Production Line for Molecular Diagnostics at the National Technology Innovation Center of the Guangdong-Hong Kong-Macao Greater Bay Area were officially inaugurated. The joint laboratory will focus on the co-development of key technologies such as microfluidics, methodologies, and detection systems for highly sensitive nucleic acid/protein testing over a three-year period.

Also unveiled was the Guangdong-Hong Kong-Macao Greater Bay Area National Innovation Center for Molecular Diagnostics Corporate Joint Innovation Center. This innovation center, based on a national-level industrial transformation platform during the 14th Five-Year Plan period, engages in external cooperation through various comprehensive models such as joint development, integrated medical chip solutions, OEM product development, and market collaboration. With advanced in vitro detection technology, it empowers fields like molecular diagnostics within the IVD sector, promoting the rapid development of high-end IVD medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area!