Home Day6 Biotech Secures Tens of Millions in Series A Funding to Develop World-Class, Low-Cost Integrated Microfluidic Molecular Diagnostic Platform

Day6 Biotech Secures Tens of Millions in Series A Funding to Develop World-Class, Low-Cost Integrated Microfluidic Molecular Diagnostic Platform

Sep 10, 2021 08:00 CST Updated 08:00

The COVID-19 pandemic has propelled the molecular diagnostics industry into the spotlight, capturing the attention of both institutional and individual investors. Enthusiasm for molecular point-of-care testing (POCT) among investors has also surged. In the first half of 2021, 39 mergers and acquisitions were announced or completed globally in the in vitro diagnostics (IVD) sector, with nearly one-quarter of the capital flowing into the molecular POCT segment. The strategic deepening by IVD giants further validates the view that the molecular POCT track holds substantial growth potential and market space. Given China’s current stage of industry development and policy support orientations, we anticipate that more emerging Chinese diagnostic companies will enter the international arena and compete alongside established giants.

 

VCBeat has learned that Day6 Biotech, a startup developing next-generation “microfluidic all-in-one” technology, recently announced the completion of its Series A financing round, raising tens of millions of RMB. The round was led by Songze Capital, with participation from existing investor Qingjie Capital, which also served as the exclusive financial advisor. The funds raised will be used to support clinical trials and NMPA registration for Day6 Biotech’s molecular POCT products—featuring “walk-in testing, low-cost consumables, and one-step operation”—as well as to expand the company’s R&D pipeline.


Day6 Biotech boasts a highly formidable core team. Its members hail from world-leading research institutions such as the Chinese Academy of Sciences, the California Institute of Technology, and the Lawrence Berkeley National Laboratory in the United States. The team possesses nearly 40 years of R&D and commercialization experience in the fields of microfluidics and in vitro diagnostics (IVD). It has extensive expertise and a proven track record in various aspects of IVD product design involving microfluidic technology, including sample collection, reagent storage, mixing, transport, design of pumps and valves, optical technologies, heating technologies, and waste fluid management. The Day6 Biotech team has developed multiple groundbreaking, internationally renowned IVD products, such as the RapidHiT, the world’s first microfluidic rapid forensic DNA testing system; China’s first time-resolved fluorescence immunoassay analyzer; and glycated hemoglobin analyzers. These instruments collectively perform over 20 million tests annually.


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Day6 Biotech’s “All-in-One Molecular Diagnostic System”: High Nucleic Acid Extraction Efficiency and Purity, and High Detection Sensitivity


After several years of development, Day6 Biotech has successfully launched the IO Series All-in-One Molecular Diagnostic System, an intelligent molecular diagnostic platform capable of rapidly identifying multiple infectious agents. This integrated system employs high-efficiency solid-phase lateral flow nucleic acid extraction, multiplex real-time fluorescent PCR, fully integrated microfluidics, and lyophilization technologies. It features high nucleic acid extraction efficiency and purity, as well as superior detection sensitivity, with a limit of detection for SARS-CoV-2 nucleic acid testing below 100 copies/mL.

 

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A single test enables quantitative analysis of 72+ molecular targets


The disposable reagent cartridges compatible with the IO series of all-in-one molecular diagnostic systems contain 12 independent reaction chambers. Each chamber can detect 4–6 targets, enabling semi-quantitative and quantitative analysis of up to 72 pathogen molecular targets in a single test. The system not only provides accurate and intuitive results directly but also allows users to view raw amplification curves and Ct values, offering reliable evidence for differentiating mixed infections, colonizing bacteria, and opportunistic pathogens. These disposable reagent cartridges are widely applicable for detecting infectious diseases of the respiratory, gastrointestinal, and genital tracts, comprehensively covering known common pathogenic microorganisms and drug-resistant bacteria.

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The entire testing process takes only 30 minutes, truly enabling “instant” report availability.


The disposable reagent cartridge is preloaded with lyophilized reagents, enabling transportation and storage at room temperature with an extended shelf life. Its fully enclosed structure securely contains all dry and wet reagents as well as waste liquids, effectively preventing leakage and ensuring biosafety. During operation, manual handling by staff takes no more than one minute. After sample loading, the system automatically completes the entire experimental process, including nucleic acid extraction, amplification, and analysis. The entire procedure can be completed in as little as approximately 30 minutes, allowing for immediate access to test results. This truly realizes the molecular POCT concept of “sample in, result out, fully enclosed.” The system is widely applicable in scenarios such as disease control centers, outpatient and emergency departments, customs checkpoints, and mobile containment units.


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“Fully Integrated Microfluidic Cartridge” Will Truly Break Through the Cost Control Challenge


In terms of industrialization, Day6 Biotech explored various design solutions and developed ultra-precision injection molding technologies and encapsulation materials, ultimately achieving the optimal solution for cost control and improved yield rates.


First, the main body of the reagent cartridge, featuring micron-level precision, is manufactured through a single-step injection molding process. This streamlined production workflow reduces the cost to as low as one-fifth that of comparable imported products after mass production, thereby avoiding the low yield rates and elevated costs associated with previous-generation molecular microfluidic products, which required complex assembly from multiple separately molded components due to their intricate structures.


Second, the instrument is amenable to mass production. The fully enclosed cartridge resolves issues related to channel cleaning and fluidic drive, enabling operation with conventional motors and facilitating scalable manufacturing. Proprietary modular ultra-sensitive optical modules and high-speed thermal cycling components enhance sample turnaround time, thereby reducing operational costs.


Third, it reduces transportation costs. The cartridge is pre-loaded with lyophilized reagents, allowing for room-temperature transport and storage with an extended shelf life, thereby saving 90% in logistics costs compared to traditional nucleic acid testing reagents that require cold-chain transportation.


Currently, Day6 Biotech has completed the R&D of its all-in-one device and reagent cassettes for upper respiratory tract infections, officially entering the registration clinical trial phase. The company is now collaborating with multiple top-tier Grade 3A hospitals to conduct clinical studies. In its future product pipeline, Day6 Biotech plans to develop detection panels for microbial pathogens based on comprehensive disease symptom profiles, including lower respiratory tract infections, multidrug-resistant bacterial infections, and genital tract infections, as well as expand into related applications such as molecular pathological diagnosis of tumors.