FlashDx Completes Tens of Millions RMB Pre-A Financing to Advance Low-Cost POCT Molecular Diagnostics

VCBeat (WeChat ID: vcbeat) has learned that Shanliang Technology announced it had oversubscribed its Pre-A financing round by tens of millions of yuan.Led by Zhejiang Minsheng Investment, with Huaying Investment as a co-investor, and Blue Rainbow serving as the exclusive financial advisor. The funds raised will be primarily used to advance the company’s GMP facility construction, medical device registration, and other related activities, as well as to expand its R&D pipeline.

Previously, Shanliang Technology secured tens of millions of yuan in angel-round financing in 2018, jointly invested by Miracle Light Venture Capital Fund and the Zhongguancun Medical Engineering Translation Center.

Shanliang Technology is a provider of point-of-care molecular diagnostic solutions based on microfluidics technology. Leveraging its independently developed rapid molecular diagnostic platform, FDx-1000, the company enables fully enclosed, one-button, sample-to-result rapid multiplex nucleic acid testing. This technology is widely applicable in pathogen detection for infectious and infection-related diseases (such as upper respiratory, gastrointestinal, and reproductive tract infections), companion diagnostics, medication guidance, identity verification, environmental monitoring, food safety, and other fields.

Regarding this round of financing, the company stated that it is attributable to Shanliang Technology’s unique technological approach in POCT molecular diagnostics, which differentiates its offerings from domestic and international competitors, thereby endowing its products with multiple, quantitative, and cost-effective comprehensive advantages. Furthermore, the management team’s extensive technical expertise and managerial experience accumulated over many years in the industry have ensured the rapid advancement of R&D projects and the successful commercialization of products.

POCT molecular diagnostics has long been a highly competitive sector in China. A major challenge in this field has been ensuring the sensitivity and accuracy of multiplex testing while controlling detection costs. Shanliang Technology, through its integration ofQuantitative Fluorescent PCRwithGene ChipTechnology has overcome this challenge.

Multiplex Quantitative Fluorescent PCR AssayIt is a common molecular diagnostic method for pathogens, capable of simultaneously detecting multiple microorganisms within just a few hours. However, the entire testing process requires operation by trained professionals and the use of high-cost, large-scale equipment (particularly for assays utilizing multiplex fluorescent probes), and must be conducted in strictly controlled laboratory and sample handling environments.

Gene ChipSpecial glass slides coated with DNA microarrays are typically used, enabling the immobilization of thousands to tens of thousands of nucleic acid probes on an area of just a few square centimeters. A single assay can provide extensive information related to gene sequences, offering the advantages of speed, precision, and low cost. Currently, this technology is primarily applied in areas such as prenatal diagnosis, pharmacogenetic testing for drug metabolism, and susceptibility gene testing.

Dr. Yue Min, founder of Shanliang Technology, introduced to VCBeat that the company’s strategy is preciselyIntegrating quantitative fluorescent PCR and gene chip technology into a compact, portable device, users only need to add the sample to a disposable test kit and then insert the kit into the device. The device will automatically recognize the test kit, thereby completing the subsequent multiplex nucleic acid testing process, including sample processing, nucleic acid amplification, and chip hybridization.

“Since the different array positions on a gene chip can distinguish amplification products, there is no need to use multiple fluorescent probes; single-color fluorescence alone can achieve detection comparable to multiplex qPCR, enabling simultaneous quantitative detection of dozens to hundreds of targets,” introduced Dr. Yue Min. “In simple terms, we have achieved multiplex quantitative PCR by combining quantitative fluorescent PCR, gene chip technology, and single-color fluorescence. We integrated traditional technologies to drive innovation.”

The characteristics and advantages of this integration of traditional technologies are:Detection is performed during each amplification cycle, significantly reducing the time from sample to result to 30 minutes to 1 hour., while the increased sampling frequency also significantly enhances data reliability。

In addition, in terms of cost control, Shanliang Technology also has its own strategy of “extreme cost reduction”.

First, the cartridge components in Shanliang Technology’s testing system are all made of plastic, enabling mass production through conventional injection molding. The microvalves and micropumps within the cartridges require only standard stepper motors for operation, eliminating the need for customization. This also facilitates the industrial mass production of the testing equipment, thereby reducing manufacturing costs.

Second, Shanliang Technology’s reagents are all lyophilized and can be stored at room temperature, eliminating the need for cold-chain transportation and reducing logistics costs.

Finally, the company has integrated molecular biology, chemistry, and engineering approaches into its overall system design, leveraging multidisciplinary technologies such as microfluidics, fluorescence detection, surface chemistry, and intelligent image processing to reduce costs across all stages.

Currently, Shanliang Technology has completed the R&D of the prototype and test kits for its instant molecular diagnostics platform, and the products have entered the registration phase. The company is also actively expanding the R&D of other related applications for its technology platform.

Regarding the investment in Shanliang Technology,Mr. Yuan Huagang, Managing Partner of Zhe Min Toustated, “We are honored to serve as the lead investor in Shanliang Technology’s current funding round. We are optimistic about the development potential of multiplex microfluidic PCR testing technology and recognize its market prospects in areas such as upper respiratory tract infections, tumor detection, and companion diagnostics. Shanliang Technology’s products are benchmarked against bioMérieux’s FilmArray, the global industry leader in the field of multiplex point-of-care molecular diagnostics. Based on entirely new technical principles, it has achieved significant breakthroughs in simplifying reaction processes, shortening reaction times, and increasing the upper limit of multiplexing capacity. We hope to leverage Zhejiang Minsheng Investment Group’s ecosystem capabilities in the life sciences sector to empower Shanliang Technology, accelerating its product commercialization and market expansion.”

Mr. Yi Lifu, Founding Partner of Huaying Investment“Huaying Investment places particular emphasis on innovative breakthroughs in technology within the healthcare sector. Our investment in Shenzhen Shanliang Technology Co., Ltd. is driven by two key factors: first, we are optimistic about the substantial growth potential of molecular diagnostics in the future; second, we have confidence in the team led by Dr. Yue Min, which possesses strong innovative technical capabilities and extensive industry experience in the in vitro diagnostics (IVD) field. In the medical device sector, IVD has consistently been a focal point for investment, as well as a priority area for product innovation and import substitution. Currently, the molecular diagnostics sector is experiencing rapid development, with clinical demand—particularly at the primary care level—growing swiftly. National policies promoting tiered diagnosis and treatment and the decentralization of medical resources will further accelerate the rapid development of point-of-care testing (POCT). There is a significant unmet demand for POCT products among primary care institutions and those at the district and county levels. We believe that Shanliang Technology’s products hold immense market potential.”

Zhejiang Private Enterprise United Investment Co., Ltd. (hereinafter referred to as “Zhe Min Tou”) is a large-scale joint-stock industrial-financial investment company that aggregates capital and financial resources from outstanding private enterprises in Zhejiang Province. Spearheaded by the Zhejiang Provincial Federation of Industry and Commerce and guided by the Zhejiang Provincial Financial Affairs Office, Zhe Min Tou was jointly established in April 2015 by eight leading private enterprises and institutions in Zhejiang, with an initial registered capital of RMB 5 billion.

Zhejiang Minsheng Investment Group focuses on advanced manufacturing/high-end equipment, healthcare, TMT, and mass consumer sectors, employing two investment models: “controlling-stake investment” and “strategic investment.” It has completed investments in 38 projects to date, with the combined market capitalization of its listed companies and assets under management exceeding RMB 30 billion. The company has established a broad presence in the big health sector. In 2017, it executed the first hostile tender offer in the history of China’s A-share market by acquiring Shuanglin Biological (000403). Other healthcare investment cases include Guobang Pharma, CMR, and Robocath.

Huaying Investment was established in April 2016 as a venture capital firm dedicated to the healthcare and technological innovation sectors. The management team at Huaying Investment boasts extensive experience in hard technology, the internet, and the health industry. Adhering consistently to the strategy of “thinking like entrepreneurs,” the firm provides founders with comprehensive, supportive services across industry resources, product development, and technology.

Huaying Investment currently manages two funds, with assets under management totaling nearly RMB 700 million. Its investment focus spans digital and tech-driven healthcare, sports and wellness, and IoT product technologies, with a particular emphasis on technological advancements and breakthrough innovations in the medical sector. As of the second quarter of 2020, it had completed investments in more than thirty early- to mid-stage startups.