Life Technologies said this week that its 7500 Fast Dx real-time PCR instrument and 3500 Dx Series Genetic Analyzer have been approved for in vitro diagnostics use in Japan.
Both platforms were filed as diagnostic application instruments to the Tokyo Metropolitan Government in March, Life Tech said. Their approval as "bona fide diagnostics" signifies Life Tech's recent approval by the Tokyo Government to operate as a medical company or market authorization holder within Japan, the company said.
The 7500 Fast Dx enables labs to complete real-time PCR amplification and quantify nucleic acids in less than 40 minutes, according to Life Tech. The instrument's software suite includes customizable security settings; and versatile security, auditing, and e-signature applications that allow users to record all instrument operations, the company said.
With the 7500 Fast Dx, Japanese clinical laboratories and institutions that develop in vitro molecular diagnostic assays in oncology, genetic disease, and infectious disease will now be able to use the instrument to develop tests for clinical applications.
The 3500 Dx Series is a capillary electrophoresis system for nucleic acid analysis that is intended for use in the analysis of human DNA or RNA for detecting genetic changes that may lead to disease presence or susceptibility. The system can run as many as 1,100 sequencing samples or 1,200 genotyping samples per day.
Roche said this week that it has filed for US Food and Drug Administration clearance of Cobas CT/NG, the company's molecular test for Chlamydia trachomatis and Neisseria gonorrhoeae for use on the Cobas 4800 platform.
Cobas CT/NG is a standardized and fully automated qualitative in vitro test for detecting CT/NG in patient specimens. The test amplifies target DNA using PCR and nucleic acid hybridization to detect the bacteria in a single analysis.
The test received the CE Mark in 2009 and is currently available in multiple countries besides the US. The Cobas 4800 was recently introduced in the US along with Roche's FDA-approved test for human papillomavirus.
"With this test, Roche will expand the menu on the recently approved Cobas 4800 platform currently in use in the US for HPV testing," Paul Brown, head of Roche Molecular Diagnostics, said in a statement.
Roche is presenting clinical trial data on Cobas CT/NG this week at the European Congress of Clinical Microbiology and Infectious Diseases in Milan, Italy.