Officialannouncement! Disigns completes and starts to operate GMP plant, boosting the standardization process of mass spectrometry technology in clinical application

As one of the two most important technical platforms for precision diagnostics, mass spectrometry technology has been continuously discovered and valued for its high specificity, high accuracy and high-throughput. However, due to the lack of very mature, generic and registered reagents in current market, there is a broad prospect for standardized clinical application of such technology.

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How to promote the standardization process of mass spectrometry detection in China so that this international advanced technology can enter thousands of hospital laboratories to serve patients? On October 17, the GMP plant of Zhejiang Disigns Diagnostics Technology Co.,Ltd- an innovative joint venture based on clinical mass spectrometry technology, was officially completed and put into operation, which may give an answer.  

 

As a joint venture co-established in Hangzhou by DIAN Diagnostics and a wholly-owned subsidiary of SCIEX- a mass spectrometer manufacturer under Danaher Group, Disigns Diagnostics was established in November 2017, devoted to realizing the transformation and application of international advanced mass spectrometry detection technology in China, and engaged in developing, registering and selling in China the in vitro diagnostic reagents / kits for class I, II and III instruments and supporting 4500MD or other SCIEX instruments.

 

The completion of the plant marks that Disigns Diagnosticss Class I in vitro diagnostic kits registered in September this year will be officially put into production, which also means that the limitations of clinical mass spectrometry technology in China will be broken at one stroke, and that China's mass spectrometry industry will usher in profound changes in technologyR&D, technology introduction and transformation, and local commercial development and application.

 

At the completion ceremony, Peng Yang, president of Danaher China and North Asia and chairman of Disigns Diagnostics, and Chen Haibin, chairman of DIAN Diagnostics, jointly unveiled the red silk symbolizing the full launch of Disigns Diagnostics, All directors and employees of Disigns Diagnostics attended the ceremony to witness this important moment.

 

Peng Yang, president of Danaher China and North Asia and chairman of Disigns Diagnostics said in his speech that as the representative of Danaher, he was very pleased to see such a successful cooperation with DIAN Diagnostics. He still remembered that he had thought carefully from all aspects and had been full of anticipation last year when selecting sites for Disigns Diagnostics and its plant. Today is a historic day. In such day, the exciting joint venture went into operation, which would promote the mass spectrometry technology into a broad clinical market. He was optimistic about the future prospects, and also believed that with the support of Danaher and DIAN Diagnostics, Disigns Diagnostics will definitely thrive very well.

 

Chen Haibin, chairman of DIAN Diagnostics, remarked that upon one years preparation, the completion ceremony today marked the official operation of Disigns Diagnostics. After nearly a years gestation from the engagement between DIAN Diagnostics and Danaher in last November, a Chinese mixed-blood was born today. Danaher Group was a well-known company in the world, who supported the established of Disigns Diagnostics with its rich experience. DIAN Diagnostics, as a local third-party diagnostic laboratory in China, had been seeking for transformation and upgrading in recent years and had transformed from channel service to in-depth development to adapt to the future diagnostic era driven by innovation. Disigns Diagnostics was the child of DIAN Diagnostics and Danaher, the global giant in cooperation. Such mode provided a good demonstration for DIAN Diagnostics to develop future industrial clusters. He hoped that both parties would work hard together under the guidance of a common strategy and direction to grow Disigns healthily.

 

Since the official cooperation between DIAN Diagnostics and the wholly-owned subsidiary of SCIEX in China in November 2017, Disigns Diagnostics has completed a series of actions during less than one year, including company registration, introducing expert team, building clinical mass spectrometry technical platforms leading in China, establishing quality systems compliant with the production standards of in vitro diagnostic reagents, completing GMP plant, and registering Class I in vitro diagnostic kits, which lays a solid foundation for the plan to launch Class II and III in vitro diagnostic reagents successively in 2019.

 

In the future, relying upon SCIEX's world-class equipment and technology in the field of mass spectrometry detection, as well as the powerful service ability of DIANs domestic third-party medical detection platforms and its sales network, Disigns Diagnostics will be committed to the R&D, registration, manufacture and sales of Class I, II and III in vitro diagnostic products, promote the localized application of high-end mass spectrometry technology, cultivate professionals in clinical mass spectrometry, and actively promote the development of mass spectrometry industry in China, so as to truly change the lives of Chinese people with mass spectrometry technology and contribute to the final popularization of precision diagnostics and treatment in China!