LinZhi Tech Files IPO Prospectus: Pioneering Hardware-Free Quantitative Diagnostics via Proprietary Image Recognition Algorithms

There are countless companies and products in the market engaged in quantitative analysis for in vitro diagnostics (IVD). If asked what sets Shanghai Linzhi Technology’s IVD quantitative analysis apart, their approach is truly innovative. Traditional IVD quantitative analysis relies heavily on front-end detection hardware; whether for blood or urine analysis, samples must be collected by front-end hardware before the data can be analyzed to diagnose specific biochemical indicators.

“Hardware test results inevitably contain errors. As an industrially manufactured product, hardware inevitably has minor defects arising from the production and processing stages. This means that even when all external interferences are eliminated during user testing and the POCT assay itself is accurate and effective, errors stemming from the hardware itself remain difficult to avoid.” Huang Jiesheng, founder of Shanghai Linzhi Technology, commented on traditional in vitro diagnostics (IVD). “Having previously been engaged in software and hardware development related to POCT, I recognized the issues inherent in hardware-based in vitro testing. This led me to establish a POCT software service provider aimed at reducing testing costs for users while expanding testing scenarios and available test items.”

POCT is a form of point-of-care testing, also known as "bedside testing." As the name suggests, it is a novel diagnostic method that enables physicians to perform rapid tests at the patient’s bedside (i.e., at the sampling site) using portable analytical instruments. This approach is not constrained by time or location for diagnosis, allowing patients to receive diagnostic results within minutes or even seconds.

Given the numerous advantages of POCT, Huang Jiesheng believes that point-of-care testing can become the preferred in vitro diagnostic method for reducing reliance on hardware in the future. With a background in communication engineering and experience in the design and development of quantitative POCT products, establishing a specialized company in the medical diagnostics sector and effectively implementing POCT software in clinical settings appears to be a cross-disciplinary endeavor for him.

Huang Jiesheng explained, “Although the medical field has high technical barriers, Shanghai Linzhi Technology has expanded its applications based on existing technologies, thereby avoiding, to some extent, the challenges posed by these high barriers.” POCT technology has long been available in the market, and image recognition technology has also seen widespread application. Shanghai Linzhi Technology builds upon these established technologies to achieve integrated applications that empower and optimize existing solutions.

What exactly is this kind of application integration? How can in vitro testing be achieved through pure software? This is likely the most puzzling aspect. Huang Jiesheng explained to VCBeat, “We only need a test strip and a smartphone to perform in vitro testing. Users first collect urine, blood, or saliva samples using the test strip, and then transmit image information of the strip to our system by taking a photo with their phone. By recognizing changes in the test strip via image analysis, the system intelligently analyzes various physiological parameters of the patient based on established models. It then combines these results with a matched knowledge base to deliver testing data, along with preventive measures, treatment plans, and recommendations, to patients for their reference and decision-making.”

Shanghai Linzhi Technology incorporates external interferences, such as ambient light during imaging and the inherent sensitivity of POCT test strips, into its algorithm development to ensure result accuracy at the data level when implementing digital quantitative analysis for in vitro diagnostics. The software also guides users to operate under optimal environmental conditions, akin to the structured instructions provided for uploading ID cards, thereby striving to ensure the accuracy of front-end data acquisition.

In addition to acquiring front-end data through images, Shanghai Linzhi Technology will also explore other methods in the future, such as using video and tissue sections, to further ensure the authenticity of the acquired front-end data.

Currently, Shanghai Linzhi Technology’s POCT algorithms are capable of detecting over 200 physiological parameters, covering specific test categories such as hormones, tumor markers, cardiac markers, infection and inflammation markers, diabetic nephropathy markers, infectious diseases, drugs of abuse, and food safety. The detection methods involve quantitative analysis of solid-phase reagents—including dry chemistry, colloidal gold, and latex agglutination assays—as well as liquid-phase reagents utilizing colorimetry, pH indicator methods, and immunoturbidimetry.

Among them, Shanghai Linzhi Technology’s assays for human chorionic gonadotropin (hCG) and luteinizing hormone (LH) have been largely perfected, enabling their use in reproductive diagnostics to accurately determine gestational age and ovulation timing.

Huang Jiesheng emphasized, “Modern people are increasingly concerned about their health, yet many fail to pay sufficient attention when diseases present only minor symptoms, neglecting to undergo relevant testing. By the time these minor symptoms progress into serious illnesses, treatment becomes significantly more difficult. The underlying reason is that people lack both the habit and the equipment for regular testing. Our POCT software reduces the complexity of in vitro diagnostics, encouraging individuals to incorporate in vitro diagnostic testing into their daily lives, thereby transforming high-cost, low-frequency testing into low-cost, high-frequency testing.”

Shanghai Linzhi Technology began developing this POCT algorithm in September 2018. The company is currently preparing to apply for CFDA and FDA certifications, with future applications potentially targeting three major scenarios: early cancer detection, food hygiene and safety testing, and disease detection in pets.

Huang Jiesheng stated, “Shanghai Linzhi Technology can determine whether tumors are present in a user’s body by detecting their tumor markers. If a user’s test results show elevated tumor marker levels, it suggests that the patient may have cancer. Our test results do not provide a definitive cancer diagnosis; rather, they inform patients of their potential risk of developing cancer based on tumor marker levels, enabling them to undergo early screening, prevention, and treatment.”

Regarding the future, the company primarily targets C-end users, with the goal of becoming a provider of primary care early screening services. By offering lower testing costs and a superior user experience, it aims to shift testing from low-frequency to high-frequency usage, thereby nipping serious and critical diseases in the bud. For B-end clients, the company focuses on drug and substance abuse testing, providing technical services and support to national government agencies and departments. Huang Jiesheng stated that Shanghai Linzhi Technology will continue to explore its future development direction.

Currently, Shanghai Linzhi Technology has launched its angel round of financing, aiming to raise RMB 5 million for qualification certification, product expansion and R&D, intellectual property protection, and product testing.