NEW YORK (GenomeWeb News) – Molecular diagnostics and genetic analysis products developer CapitalBio has received certification from China's State Food and Drug Administration for two microarray-based tests and for one amplification-based test for tuberculosis.
The two microarray assays can identify tuberculosis from spit samples, and they were developed for use with the company's LuxScan scanning and analysis tools, according to firm, which is based in Beijing.
The amplification test is used to quickly distinguish M. tuberculosis from non-tuberculosis mycobacteria (NTM).
The three TB tests recently received CE Mark certifications in the European Union.
"CapitalBio recently received SFDA certificates for two other IVD products, an antinuclear antibody test array kit and deafness gene mutation detection array kit, which also applied pioneering microarray technologies," CapitalBio CEO Jing Cheng said in a statement.
Cheng said that the company expects to receive further SFDA approval for nine additional products before the end of May, including microbead-based assays for detection of diabetes and thyroid diseases.