Microfluidic + POCT.
With the continuous advancement of biotechnology, there are two development trends in medical devices: first, to a more “high, precise, integrated” direction; second, to “simple, convenient, personal health management” Direction development. The size of the product is small, the operation is simple, and the results are timely. The product of POCT has been produced and developed rapidly. Data shows, global POCT 2017 market size is about $14 billion It is expected to reach a market size of US$24 billion by 2026; in 2017, China’s POCT market will be approximately US$600 million and will reach approximately US$1.5 billion by 2026.
Microfluidic technology products can play a significant role in POCT due to their accuracy, convenience, economy and efficiency. Specifically, first, the emergence of microfluidic technology and products has broadened the application scenarios of IVD, including many complex scenes such as grassroots hospitals, emergency sites, battlefields, etc. Second, the test information throughput has been improved, and one detection has been realized. Multiple indicators; Third, the integrated and automated analysis system also brings operational convenience; Fourth, the use of micro-analysis system, saving reagent consumption. Therefore, Microfluidic technology products are called “leaders” in the POCT era by most industry insiders.
Microfluidic chip (Source: Oriental IC)
Many companies are currently deploying here, such as micro-nano core, Micro-point bio, 华迈兴微, 100 Kangxin, Beijing Boao, etc., they all have good performance in microfluidic device manufacturing. Performance. However, China’s microfluidic chip technology is still in its early stages of industrialization, and it is still a huge blue ocean market.
The recent contact with “Pu-Kang” is also here. According to the founder and CEO Dr. Yu Bo, the core positioning is mainly based on centrifugal microfluidics. Technology platform to explore medical applications in the fields of coagulation (ie thrombosis and hemostasis), chemiluminescence immunity, including POCT testing instruments, microfluidic disk chips and supporting diagnostic reagents. Before, it has received two rounds of investment in the flooding investment.
The residual wave indicates that, from a technical point of view, centrifugal microfluidic technology (based on the centrifugal disc core to achieve fluid control) compared to microfluidic technologies such as chip, cassette, and droplet type, It is very convenient to achieve complete blood separation and parallel detection of multiple samples and multiple indicators.
This also means that it is more cost-effective and practical in practical applications, and has obvious advantages in industrialization, especially for the current market situation in China – including the promotion of grading diagnosis and treatment The demand for testing equipment in primary hospitals, the rise of private medical care, the increase in demand for emergency/ICU, and the rise of consumer medical (oral, medical, etc.) and pet medical markets etc.
The first to cut into coagulation, the aftermath of frankness, in fact, is a bit “beating”: the initial team wanted to use chemiluminescence as an entry point, but the team’s technical reserves did not match, but coincided with the coagulation market High-speed development – Since 2000, the compound growth rate has reached 30%, and it has been found that coagulation is a good commercial direction.
It is reported that coagulation IVD is a mandatory item for preoperative and postoperative patients, inpatients and patients with blood diseases (coagulation has PT, APTT, TT, FIB). Clinically necessary preventive measures for medical accidents and postoperative monitoring have important clinical value.
The aftermath also adds that with the increasing variety of oral anticoagulant drugs and the rise of the oral and aesthetic market, the market is smallThe demand for blood testers is becoming more and more obvious. In addition, in the field of coagulation, the past market has long been monopolized by foreign companies such as Wolfen, Sysmex, and Sita, Seccoide, Merry Plymouth >, Zhongchi Albert , Shenzhen Leishe only occupy a small part of the market share. Under the background of import substitution trend, the opportunities of domestic brands will be further released.
Therefore, in the commercial exploration, Puschik also has a microfluidic coagulation instrument, a portable small coagulation analyzer, a microfluidic chemiluminescence instrument, a microfluidic biochemical analyzer, and supporting reagents. product. Among them, its microfluidic coagulation MC500 instrument and reagent, microfluidic chemiluminescence MI600 instrument and reagent have been certified, biochemical products are being registered, portable small coagulation analyzer MC100 is ready to send registration test.
MC500 Automatic Coagulation Analyzer (Source: Puschang official website)
According to Yu Bo, MC500 has the advantage of whole blood and multi-indicator (other microfluidic products are mostly single-person), and can test 6 samples at the same time in 12 minutes. Reduce the cost of testing; MC100 can achieve whole blood sampling, single-person design, and test four items of coagulation / five or more indicators, can respond to the emergency room, operating room, part of the department’s POCT testing needs difficult to meet in the central laboratory . It is reported that in terms of hematology and coagulation, only Abbott’s i-STAT blood gas system and Roche CoaguChek® XS system are available.At the POCT level.
The residual wave indicates that the small size of the handheld device leads to an increase in the difficulty of the process. The yield of the coagulation detection chip is low. In addition, how to ensure the accuracy of each indicator is a small test and the technical barrier is high. As for the sales strategy, he introduced that its products are mainly for private hospitals and grassroots hospitals. Because of its cost-effective advantages, it can quickly open the market to realize commercial realization and support product development. However, he said that in the future, its products will be tilted toward serious channels such as emergency departments and ICUs.
Talking about the future planning of , Yu Bo said that he will also develop a thrombus elastic force detection device based on microfluidic technology and a microfluidic technology product for pet medical treatment.
It is reported that the “thrombosis map” has been widely accepted by academic circles and clinical clinics, and has a clear code for medical insurance charges. At this stage, it is in a rapid growth period. However, the detection has the disadvantages of complicated operation, low detection flux, large blood demand, high reagent cost, and cumbersome maintenance process, and development is constrained; the thrombus elastic force detection device based on microfluidic technology can break through existing detection equipment. Overcome technical weaknesses and promote application bottlenecks.
At the end, the team was introduced. Dr. Yu Bo, the founder of the National Nano and Engineering Center, was a professor at the International Centrifugal Microfluidics Testing Pioneer L. James Lee. The company is currently launching a new round of financing.