QIAGEN’s Next Generation Hepatitis C Real-time PCR Test Receives SFDA Approval
QIAGEN's Next Generation Hepatitis C Real-time PCR Test Receives SFDA Approval
Shanghai, China, March 18, 2011 - QIAGEN today announced that the Company's second generation hepatitis C (HCV) real-time (RT) polymerase chain reaction (PCR) test, the careHCV RT-PCR Kit V2, has obtained approval from the State Food and Drug Administration, P.R. China (SFDA) for HCV detection and viral load analysis. This new HCV test, based on QIAGEN's state-of-the-art sample and molecular assay technologies, was developed and is being manufactured by the Company's Shenzhen subsidiary. It is part of the Company's care product line aimed at developing and producing products that address the specific healthcare and testing needs of emerging countries.
The careHCV RT-PCR Kit V2 offers many advantages over existing testing and monitoring technologies:
- It includes an internal control for result validation.
- It can detect all key HCV subtypes.
- It is the first locally-manufactured PCR test in the domestic market that can be used in conjunction with automated sample technology solutions, such as QIAGEN's QIAcube.
"This test is the first of a range of care-branded products which combine our global and local know-how in order to bring international standards to emerging markets," said Jeff Buck Director of Molecular Diagnostics in Greater China. "With this approval, we can now offer our customers a completely standardized and automated workflow from sample to result: purification of the sample on the QIAcube and then analysis with this new HCV test using our Rotor-Gene Q real-time PCR cycler." Standardization and automation in laboratory settings helps increase the reproducibility and reliability of results, leading to improved disease management.
According to the World Health Organization (WHO), over 200 million people around the world are infected with hepatitis C - with developing countries sharing the majority of the disease burden. More than 80% of HCV infections become chronic, as symptoms are often mild in the early stages of infection, leading to liver disease and eventually liver failure. A sensitive PCR-based test can detect the amount of HCV viral RNA more accurately than traditional methods, guiding therapeutic response and improving patient outlook.
QIAGEN's new careHCV RT-PCR Kit V2 adds a critical new assay to QIAGEN's assay portfolio, and in particular to its subcategory of blood viral testing, which includes assays for HIV, HBV and others.
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. QIAGEN employs more than 3,600 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
Disclaimer: CARE is a registered trademark of COOPERATIVE FOR ASSISTANCE AND RELIEF EVERYWHERE, INC. ("CARE"). CARE and the members and affiliates of CARE International are not affiliated with QIAGEN and do not sponsor, endorse, support, participate in or control the development, manufacture, use or sale of any QIAGEN product. care products may not be available in all countries or regions.
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 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 and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, 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 its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).