Chroma Biosciences Launches FLAME Platform: A Next-Generation Ultrasensitive Protein Detection System with Single-Molecule Resolution

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 used and mature ultra-sensitive protein detection methods currently available. In this field, the Simoa platform from Quanterix Corporation 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.

Recently, Lychix (Suzhou) Biotechnology Co., Ltd. (hereinafter referred to as "Lychix") officially launched a new generation of single-molecule immunoassay platform FLAME. The platform uses a unique signal amplification technology that can stably capture trace signals difficult to detect by traditional methods. Compared with the Simoa and MSD platforms, its sensitivity has increased tenfold.

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 a solution system, combined with technologies such as full-spectrum flow cytometry analysis, achieving rapid and ultra-high sensitivity quantitative detection of different protein molecules in the same sample, representing a significant performance breakthrough.

Achieving Multiple Technological Breakthroughs

The core value of ultra-sensitive protein detection lies in "making the invisible visible," allowing key disease biomarkers in the blood, which are otherwise undetectable due to their low concentration, to be precisely quantified. "This is equivalent to finding a single red bean among trillions of green beans, which is impossible with the naked eye alone. However, ultra-sensitive protein detection enables 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 set an industry standard in multiplex detection. However, these two platforms also have significant limitations within their respective technological approaches.

The microwell array technology adopted by the Simoa platform works by concentrating a large number of signaling molecules on a physically small chip and detecting these concentrated signaling 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 explained, likening it to capturing signaling molecules and locking them into the small microwell 'rooms' on the chip, 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 signaling molecules can be captured.

While 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 processes, expanding throughput, and further enhancing sensitivity.

"We broke through the traditional design concept by using signal amplification technology, which allows the detection of signaling molecules to no longer be physically limited by micro-well arrays," Li Hui introduced. The detection method of the FLAME platform is based on a solution system, where the suspended magnetic beads in the solution have no upper limit in quantity, 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 will precisely capture the enzyme-catalyzed signaling molecules onto their surfaces. The research and development team used a previously developed full-spectrum flow cytometer, capable of reading all signals from a single magnetic bead. By increasing the number of magnetic 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, enabling free reaction and signal amplification in a solution system. As a result, it achieves technological superiority in terms of 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 with femtomolar sensitivity. When paired with an automated pre-processing system, it enables the fast 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 arrangements and higher equipment and consumable costs.

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

"FLAME Platform Expected to Advance Ultra-Early Screening and Efficacy Monitoring for Major Diseases Such as Alzheimer’s, Cardiovascular Conditions, and Cancer, While Also Providing Highly Sensitive, Multi-Indicator Parallel Analysis Tools for Biomarker Discovery and Drug Efficacy Evaluation. In Scientific Research, the FLAME platform will drive the development of upstream core components produced in China, such as optics, microfluidics, and reagents, enhancing China's self-reliance in high-end life science instruments," said Li Hui. The FLAME platform is positioned as the next-generation ultra-sensitive protein detection technology globally, with vast potential across multiple billion-dollar markets including research services, drug development, and clinical early screening. (Reporter: Shen Wei)