Domestic FLAME Platform Debuts: Breaking the Sensitivity Ceiling in Single-Molecule Immunoassays

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(Source: Global Times Information)

Source: Science and Technology Daily

Science and Technology Daily Reporter Shen Wei

Ultra-sensitive protein detection plays a crucial role in precision medicine, life science research, and early diagnosis. Single-molecule immunoassay technology is one of the most widely applied and mature technologies in the field of ultra-sensitive protein detection. In this area, the Simoa platform from Quanterix in the United States and the electrochemiluminescence platform (hereinafter referred to as the "MSD platform") from Meso Scale Discovery (MSD) have long dominated the market and are regarded as industry benchmarks.

On March 31, Lychix (Suzhou) Biotechnology Co., Ltd. (hereinafter referred to as Lychix) officially launched a new-generation single-molecule immunoassay platform, FLAME. The platform employs a unique signal amplification technology capable of stably capturing trace signals that are difficult to detect using traditional methods. Compared with the Simoa and MSD platforms, its sensitivity has improved by an order of magnitude.

Wu Aihua, Secretary General of the Analytical Instrument Branch of the China Instrument and Control Society, commented that this product innovatively adopts a signal amplification pathway in the solution system, combined with technologies such as full-spectrum flow cytometry analysis, enabling rapid and ultra-high sensitivity quantitative detection of different protein molecules in the same sample, representing a significant performance breakthrough.

Achieve Multiple Technological Breakthroughs

The core value of ultra-sensitive protein detection lies in "transforming the invisible into the visible," enabling the precise quantification of critical disease biomarkers in blood that are otherwise undetectable due to their low concentration. "This is equivalent to finding a single red bean among trillions of green beans, which is impossible with the naked eye. However, ultra-sensitive protein detection allows us to accurately locate this 'red bean,'" Li Hui, co-founder of Lychix, told reporters.

Previously, the Simoa platform has achieved femtomolar-level detection at the single-molecule level, while the MSD platform, with its electrochemiluminescence technology, has also set industry standards in multiplex detection. However, these two platforms have significant limitations under their respective technical approaches.

The microwell array technology adopted by the Simoa platform works by concentrating a large number of signal molecules on a physically small chip and detecting these concentrated signal molecules. "This method not only requires expensive microwell array chips but also complex equipment to manipulate the chips and reagents, along with powerful algorithms to complete the process. Moreover, limited by the number of microwells on the chip, this technology struggles to achieve high-throughput multiplex target molecule detection." Li Hui vividly described it as locking signal molecules into tiny microwell "rooms" on the chip and then checking if the rooms contain the target molecules. However, the number of "rooms" on a chip is fixed, imposing an upper limit on how many signal molecules can be captured.

Although the MSD platform has achieved better multiplex detection capabilities through a multi-point detection mode, it relies on an electrode array at the bottom of the microplate and dedicated electrochemiluminescence detection equipment, and similarly faces bottlenecks in simplifying operational procedures, expanding throughput, and further enhancing sensitivity.

"We broke through traditional design concepts by utilizing signal amplification technology, freeing molecular detection from the physical limitations of microwell arrays," introduced Li Hui. The detection method of the FLAME platform is based on a solution system where the suspended magnetic beads in the solution have no quantity limit, and each bead's surface itself acts as an individual reactor. After the detection sample quickly completes the immune reaction in the solution, the magnetic beads precisely capture the enzyme-catalyzed signal molecules onto their surface. The research team used a previously developed full-spectrum flow cytometer to read all signals from a single bead. By increasing the number of beads to further enhance statistical accuracy, the detection sensitivity can be significantly improved.

This technical approach not only avoids the dependence of the Simoa platform on microwell array chips but also overcomes the physical limitations of the MSD platform based on electrode arrays, achieving free reaction and signal amplification in a solution system. Thus, it surpasses in sensitivity, throughput flexibility, and operational simplicity.

Broad Application Market Prospects

With the help of magnetic beads of different encodings, the FLAME platform can also achieve high-throughput multiplex target molecule detection. It is capable of simultaneously detecting over 30 factors in a single run at femtomolar sensitivity. When paired with an automated pre-processing system, it enables the swift operation of "sample in, results out." Compared to the MSD platform, which also has multiplex detection capabilities, the FLAME platform addresses issues such as limitations in single-test throughput due to electrode array arrangement and higher equipment and consumables costs.

And due to the absence of complex steps such as the fabrication and sealing of microporous array chips, the FLAME platform is also more conducive to clinical translation. With the support of ultra-sensitive protein detection technology, simple blood sampling in clinical settings can enable non-invasive, real-time observation of microscopic pathological changes in core organs like the brain. This not only significantly advances the timing of early diagnosis for many serious diseases, securing a valuable time window for clinical intervention, but also provides insights into precise management and personalized treatment for populations affected by neurodegenerative diseases and chronic conditions through digital tracking of disease progression.

"The FLAME platform is expected to promote ultra-early screening and efficacy monitoring of major diseases such as Alzheimer's disease, cardiovascular diseases, and cancer. It will also provide highly sensitive, multi-index parallel analysis tools for biomarker discovery and drug efficacy evaluation. In scientific research, the FLAME platform can drive the development of upstream core components produced in China, such as optics, microfluidics, and reagents, enhancing China's independent and controllable capabilities in the field of high-end life science instruments," said Li Hui. The FLAME platform is positioned as the next-generation ultra-sensitive protein detection technology globally, with broad prospects in multiple billion-dollar markets such as research services, drug development, and clinical early screening.

Wu Aihua believes that the launch of Lychix's FLAME platform represents a significant technological breakthrough in the field of ultra-sensitive protein detection in China. "We are pleased to see local instrument companies being innovative and daring to lead. We look forward to Lychix further strengthening its collaboration with professional users, and as soon as possible, providing stable, user-friendly, and durable ultra-sensitive protein detection instruments for basic research, drug development, and precision medicine, achieving large-scale application in the Chinese and international markets," said Wu Aihua.