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Qiagen. (3/28/12). "Press Release: Qiagen Obtains SFDA Registration for QIAsymphony SP System. QIAsymphony SP Is the Second Instrument om Qiagen’s QIAsymphoy RGQ Platform to Be Registered in China". Shanghai & Beijing.

Region Region China
Organisation Organisation Qiagen N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA)
  Group Qiagen (Group)
Products Product QIAsymphony® SP system
  Product 2 Rotor-Gene™ 6000

> QIAsymphony SP provides a high level of flexibility in sample processing and applications

> Automation of sample preparation and downstream analysis key to dissemination of molecular diagnostics

QIAGEN today announced that it has successfully registered the QIAsymphony SP instrument with the State Food and Drug Administration, P.R. China (SFDA) for full automation of sample preparation workflows. The high flexibility of QIAsymphony SP enables the handling of an extensive variety of starting materials, such as blood and tissue samples, with a wide range of input and output volumes and formats. Over 40 protocols to isolate, purify and prepare DNA, RNA and proteins have been optimized for use on the QIAsymphony SP. The registration is a significant milestone in the Company's efforts to drive dissemination of automated solutions in the industry and to expand its offerings in key emerging markets.

QIAsymphony SP is an integral part of QIAGEN's series of modular instruments which can be integrated to automate entire workflows in a broad range of applications. Automation of sample preparation generally results in more flexible, faster and more reliable downstream analysis of genetic materials than with manual preparation protocols. Such flexibility and speed is essential for customers running high-volumes of tests in a day, such as hospitals and labs in large cities dealing with routine testing.

The QIAsymphony SP instrument has incorporated many first-of-its-kind features in molecular processing including continuous loading of sample racks, reagents, and consumables, and the ability to perform several purification procedures on one batch of samples without reloading reagents (random access), and with a constant cost per preparation no matter what batch size is run. The system is designed to provide value to customers who run just a few samples up to those running up to a few hundred in a day.

In addition to the QIAsymphony SP, QIAGEN has also developed the QIAsymphony AS for assay setup and the QIAsymphony RGQ which incorporates the stand alone Rotor-Gene® Q real time PCR thermocycler. The Rotor-Gene® Q real time PCR thermocycler received SFDA approval in September of 2010. QIAGEN expects to receive approval for the QIAsymphony AS system by the end of 2012 which will allow the company to offer the complete range (QIAsymphony SP, QIAsymphony AS and QIAsymphony RGQ) to customers.


QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. As of December 31, 2011, QIAGEN employed nearly 3,900 people in over 35 locations worldwide. Further information about QIAGEN can be found at

Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics, changing relationships with customers, suppliers and strategic partners, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors), our ability to obtain regulatory approval of our products, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products, market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Record changed: 2019-06-09


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