Tianfu Life Science Park-based Celuna China Med-Tech Co., Ltd. obtained the Class II Medical Device Registration Certificate from China Food and Drug Administration (CFDA) for its self-developed new generation of miniaturized flow cytometer. The product is the first self-owned brand product of its kind that has got approval for marketing. Relevant supporting reagents also obtained marketing certificates from the CFDA in the same period.

Extensively applicable flow cytometer

A flow cytometer is an automatic cell analyzer. It is used to rapidly measure (at the speed of more than thousands of cells per second), store and display a series of important characteristic parameters (mainly obtained from specific fluorescence signals and scattered non-fluorescence signals) in biophysics and biochemistry for dissociated cells suspended in liquid. A flow cytometer consists of four parts: Flow chamber and fluidics system; laser source and optical system; photoelectric detection system; and the computer and analysis system.

Flow cytometers are generally used for clinical testing, cytobiology studies, studies on agriculture, forestry and livestock breeding, microbiology application and food and drug tests. They are used in the clinical tests for hundreds of diseases, including infectious, respiratory, digestive, urinary, endocrine, rheumatic immune and blood diseases. The great demand for testing these diseases in China and the wide range of scientific research application make flow cytometer an indispensable testing instrument for the market.

Common flow cytometers fail to suffice for the growing market

Most flow cytometers on the market today are foreign products and localized in level-A tertiary hospitals. A high-efficient and affordable flow cytometer testing service is still unavailable to vast patients for the following reasons:

1. Prohibitively high price: A flow cytometer generally costs over RMB 500,000, and its supporting reagents are also costly, making it beyond the affordability of primary hospitals;

2. Complicated and inconvenient operation methods: A common flow cytometer requires the adjustment of multiple equipment parameters and data analysis processes; and operators should get professional training before working on it. This has increased its usage difficulty for the China market, especially for primary hospitals.

Miniaturized and easy to popularize: Celuna flow cytometer
 

Celuna’s Sparrow flow cytometer, based on its years of technical R&D and product transformation abilities, has made breakthroughs in system integration schemes, device selection and intelligent data analysis. It has achieved miniaturized and low-cost intelligent operations.

Sparrow flow cytometer is equipped with a two-tone high-performance laser device with a self-designed light path free of adjustment. It is able to test 6 signal parameters at the same time, do accurate absolute counting and handle samples automatically. The work efficiency has thus been remarkably raised. The self-developed AISFCM Chinese analysis software with foolproof one-touch operation model frees users from setting up parameters and costs merely 5 minutes to learn, thus lowering requirements on operators’ professional abilities. Offering more convenient operation settings, more accurate testing results and lower testing costs, the product is able to meet the demand of primary hospitals in China.

Sparrow flow cytometer has now been applied in a number of medical institutions and testing centers and won wide praise from them. The marketing of Sparrow flow cytometer has brought a great change to the application of flow cytometers in China’s medical sector. Featuring miniaturization and simplicity, Sparrow expands the application range of important tests to primary units and provides a low-cost and highly precision solution to the popularization of flow cytometers in China.
 

Sparrow flow cytometer

Celuna China Med-Tech Co., Ltd.

Celuna China Med-Tech Co., Ltd. is a biotechnology company committed to reproductive health and miniaturized medical devices. Its major products include flow cytometers and supporting antibody reagents as well as non-invasive prenatal testing technologies.

Celuna China was headquartered in 2013 in Tianfu Life Science Park and has offices in Shanghai, Beijing and San Diego, U.S. It has an over 5,000m2 complete base for scientific research, technical translation, production and services. The company has established close partnerships with a number of renowned enterprises and specialists at home and abroad.

Its founder, president and general manager Zhang Haichuan obtained his doctoral degree in precision instrument and machinery from Tsinghua University in 1997. He has accumulated experience in high technology R&D and enterprise management for over a decade in the U.S. and has led the establishment of including non-invasive prenatal, flow cytometer and several other core technologies. He holds more than 50-plus patents and 20-plus papers.

Source: Celuna China Med-Tech Co., Ltd.