FlashDX Advances Global Expansion with Innovative Microarray-qPCR Technology: A New Era for Affordable, Multiplex POCT in Molecular Diagnostics

Although some common diseases with clear diagnoses and established treatment protocols can be effectively managed at primary care hospitals, many people still flock to tertiary hospitals without hesitation.What they value most is actually the diagnostic capability of tertiary hospitals.For certain disease indicators, accurate diagnosis and subsequent correct treatment rely exclusively on experienced physicians at tertiary hospitals in the absence of rapid and precise diagnostic tools. In contrast, secondary hospitals and primary care institutions often lack advanced diagnostic equipment, preventing them from obtaining rapid and accurate results. Furthermore, their physicians’ limited clinical experience contributes to a suboptimal patient experience.If primary care hospitals can also perform rapid and precise testing, coupled with clear medication guidance,Enabling patients to receive quality medical care close to home may help partially alleviate the dilemma of "difficulty in accessing healthcare."

andPoint-of-Care Testing (POCT) brings “precision diagnostics” to your doorstep.POCT refers to a point-of-care, on-site testing method that utilizes portable, compact analytical instruments, features simple operation, is performed at the patient’s bedside, and delivers rapid test results. POCT originated in Europe and the United States and has been introduced to China for nearly two decades, yet it has failed to achieve widespread adoption. Due to China’s vast population base and the characteristics of its healthcare system, some imported POCT products, after entering the Chinese market,High Priceits disadvantages have become increasingly apparent, failing to meet the demands of the Chinese market.

To align POCT with China’s healthcare system, Shanliang Technology has developed a multiplex POCT molecular testing platform suited for primary care settings.

It is no exaggeration to say that Shanliang Technology was founded by a group of “academic overachievers.”

The core team of Shanliang Technology are all graduates fromTsinghua University, University of Science and Technology of ChinaStudents from these universities, with majors spanning molecular biology, electronic engineering, mechanical engineering, and even software engineering, also possess formidable business acumen.Dr. Yue Min, CEO of Shanliang TechnologyTell VCBeat: “Every member of our management team has approximately twenty years of experience in the R&D and promotion of professional molecular diagnostics products.”

Take Dr. Yue Min as an example. She previously served as Executive Director at WuXi AppTec’s NextCODE Health, Head of Cloud Platform and B2B Business, and R&D Project Leader at Thermo Fisher Scientific in the United States. She also led large-scale R&D projects worth tens of millions of dollars, including other molecular POCT platforms and first-, second-, and third-generation sequencers.

With over two decades of experience in the U.S. biotechnology industry, Dr. Yue Min has gained extensive knowledge of the POCT sector in Europe and the United States. In these regions, POCT has become widely available in pharmacies, and the public has readily accepted testing conducted at pharmacies or physicians’ offices. In contrast, China’s POCT market still holds substantial growth potential across commercial, clinical, and patient acceptance dimensions. Recognizing this significant market opportunity in China, Dr. Yue Min and his team decided to launch a venture in the domestic POCT market.

In 2018, Shanliang Technology was established in Shenzhen. Two years later, the company independently developedUltra-Multiplex POCT Molecular Detection Platformwas launched.

The ultra-multiplex POCT molecular testing platform developed by Shanliang Technology enables simple, convenient, and safe molecular testing. The testing speed of the POCT molecular testing platform, compared to traditional testing methods,6–24 hoursAccelerate to15 Minutes - 1 HourThe testing process from sample to report has been completed, significantly improving diagnostic efficiency. Shanliang Technology’s platform is particularly user-friendly, allowing operators to get started easily without professional training, thereby reducing the difficulty of promotion and widespread adoption. In addition, the reagent cartridges for Shanliang Technology’s ultra-multiplex POCT molecular detection platform have truly achievedFully Enclosed, while maintaining equivalence to traditional laboratory qPCR testingHigh Specificity, High Sensitivity, thereby ensuring the safety and accuracy of test results.

However, compared with other POCT products, Shanliang Technology’s ultra-multiplex POCT molecular testing platform has another very significant advantage: its exceptionally high cost-effectiveness. While the cost per test for other POCT solutions is high, the ultra-multiplex POCT molecular testing platform can completeNearly 20 Projectstesting.

Through technological innovation, Shanliang Technology leverages low-costMicrofluidic BiochipandMonochrome Fluorescence + CMOS Deviceto realize POCT, addressing the high hardware and consumable costs of similar products. In addition, the microarray-real-time fluorescence amplification technology developed by Shanliang Technology enables the acquisition of detection results in a single assayNo fewer than 20 types of indicator data, which not only saves time costs but also reduces consumable usage, ensuring cost-effectiveness in terms of both hardware and labor.

Dr. Yue Min stated, “Nowadays, the advantages of POCT are largely similar; the competition boils down to who offers greater convenience and better cost-effectiveness. This is also the direction in which Shanliang Technology has been striving to make breakthroughs.”

In less than five years since its establishment, Shanliang Technology has already securedFosun, Zhejiang Private Investment, Huayingand other well-known VCsInvestment Exceeding 100 Million Yuan. The primary reason VCs are bullish on Shanliang Technology is its possession of internationally leading, independently owned proprietary detection technology—Microarray-Real-Time Fluorescent Amplification Technology.

Microarray technology and real-time fluorescent amplification technology are both well-established and have been widely applied in various genetic testing projects. However, integrating these two technologies represents a novel approach.

First, in conventional TaqMan fluorescent quantitative PCR, accurate detection of samples requires the coordinated interaction between the fluorophore and quencher at both ends of the probe. However, when nucleic acid samples matching the probe sequence are present in the solution, the probe is cleaved by the DNA polymerase during PCR amplification. This cleavage separates the fluorophore from the quencher, reducing or eliminating quenching effects, thereby allowing the fluorophore to emit a fluorescent signal for target molecule detection. In cases where multiple targets need to be detected, different probes and primer pairs in multiplex qPCR require distinct fluorophores with different emission wavelengths. When the number of targets increases, the optical system of the instrument and the spectral properties of the reagents become severely limited, necessitating physically separate reactions, which leads to increased costs.

Shanliang Technology combines microarray technology with real-time fluorescent amplification through innovative approaches, utilizing biochips and monochromatic fluorescence to overcome this limitation, thereby achieving cost-effective quantitative detection of multiple specific sequences.

In the words of Dr. Yue Min, “Microarray-real-time fluorescent amplification technology represents a fusion and subsequent upgrade.” This patented technology not only retains the traditional microarray technology’sSensitivity and Specificity, while requiring only single-fluorescence detectionMultiplex Quantitative Nucleic Acid Testing. Truly realize an instant, ultra-multiplex molecular diagnostic solution that is simple to operate and cost-effective.

As of now, Shanliang Technology’s POCT product series has obtained EU CE-IVD registration and domesticClass III Medical Device Registration Certificate, and multiple respiratory pathogen detection kits are undergoing clinical trials.

Supported by patented microarray-real-time fluorescent amplification technology, Shanliang Technology’s products have also expanded beyond China, with sales in Europe, South America, and other regions. Meanwhile,SYNLAB, the European Leader in Laboratory MedicineAt the 8th ANL Conference, Shanliang Technology also proactively introduced its ultra-multiplex POC molecular testing platform to experts in the field of laboratory medicine. During the conference,SYNLAB is highly satisfied with the accuracy of Shanliang Technology’s products, as well as their simple and intuitive user interface, rapid testing capabilities, and easily interpretable amplification curves.They conducted a pilot study on SARS-CoV-2, influenza A, influenza B, and RSV using an ultra-multiplex detection platform. The study demonstrated that the platform could simultaneously and accurately measure multiple targets, with no false positives, false negatives, or cross-reactivity with other viruses observed, thereby validating the accuracy and professionalism of Shenzhen Shanliang Technology Co., Ltd.'s products.

However, the industry acclaim has not caused Shanliang Technology to rest on its laurels; remaining true to its original mission, the company is committed to providing the market with higher-quality POCT products. It has formulated its next steps from both product and market perspectives.

Shanliang Technology remains true to its identity as a technology-driven company, striving to build a comprehensive, multi-dimensional diagnostic platform based on microarray-real-time fluorescent amplification technology. In terms of market strategy, in addition to continuing to promote the regulatory approval of its existing products in overseas markets, Shanliang Technology is actively engaging in deep strategic collaborations with industry partners both domestically and internationally. Together, they aim to co-develop more applications and products on the existing technological platform to benefit the general public.

Shanliang Technology is highly eager for collaboration with all parties, both in terms of product development and market expansion, to integrate more advanced technologies and achieve a comprehensive upgrade of the industry. As Dr. Yue Min stated:“Only by pooling the strengths of the entire industry, eliminating the dross and selecting the essential, and driving innovation to fill existing gaps can we advance the overall ecosystem development of POCT.”