European CE mark for three Tuberculosis test products from CapitalBio Corporation
Beijing, China. 2 April 2009. CapitalBio Corporation, China’s leading developer of microarray diagnostic products and total analysis solutions announced the certification of three products for diagnostic tuberculosis testing with the European CE mark.
“The certification of the TB test microarrays with European CE marks represents a major step forward in our efforts to bring better diagnostics to the developing lands of the world and also to the countries of Europe” said Jing Cheng, CEO of CapitalBio. “CapitalBio has worked closely with the National Tuberculosis Reference Laboratory of the China Center for Disease Control and Prevention to provide assays of international relevance. We see enormous potential for the use of this technology to aid TB sufferers in China and across the world.”
Two products are microarray-based assay kits. One microarray for the identification of up to 17 mycobacteria species allows precise identification of the infection and informs the physician of choices for correct treatment. The second microarray for the detection of drug resistance in M. tuberculosis bacteria ensures that doctors provide the correct anti-tuberculosis drug treatment. Both microarray assays can test for tuberculosis directly from patient sputum samples and require only 6 hrs from sample collection to validated result. The microarray kits are supported with a full suite of instruments and dedicated software that provides a patient diagnosis automatically from the assay result.
The third assay is based on Real-time PCR and discriminates between tuberculosis mycobacteria and non-tuberculosis mycobacteria (NTM) in a highly sensitive assay in under 3 hr. This test can then guide the physician in the choice of particular detailed microarray assay for precise diagnosis.
ABOUT CAPITALBIO
CapitalBio Corporation is located in Beijing and is China’s leading developer and marketer of diagnostic biochips, microarray related instruments and microarray services. The company, founded in 2000, currently has nearly 400 employees and is closely linked to the National Engineering Research Centre for Beijing Biochip Technology. Visit www.capitalbio.com for more information.

