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NorDiag ASA CE IVD labels its high throughput instrument (Bullet)
17 December 2008: NorDiag ASA CE IVD labels its Bullet instrument. - CE IVD labeling increases the revenue potential for the product substantially, explains Mårten Wigstøl, CEO in NorDiag.
The CE IVD labeling comes after successfully completing clinical trials comparing the BUGS`n BEADS(TM) sample preparation reagentswith both the Roche COBAS® TaqMan® 48 Analyzer and COBAS® TaqMan® CTTest, v2.0 and the BD ProbeTec(TM) ET Chlamydia trachomatis Amplified DNA Assay for isolation of STI`s from urines, using Chlamydia trachomatis as a model for organism. In addition to the CE IVD labeling of its Bullet instrument, NorDiag also extends the CE IVD claims for the BUGS`n BEADS(TM) sample preparation reagents.
`This is an important milestone for us since the CE IVD labeling is paramount for successful commercialization of our automated sample preparation systems,` says Mårten Wigstøl, CEO in NorDiag, and adds; `the achieved milestone increases the revenue potential both with existing and new customers.`
NorDiag has fully automated the sample preparation for sexually transmitted infections from the primary urine tubes to the set up of both the BD (Becton Dickinson) ProbeTec ET system and the Roche COBAS® TaqMan® 48 system. NorDiags high throughput instrument Bullet has the capacity up to 100 000 isolations per year.
Contact: CEO Mårten Wigstøl Phone. +47 911 65775
About NorDiag:
NorDiag is a biotechnology company developing, manufacturing and marketing automated solutions, instruments and tests, for diagnostic of infectious diseases and cancer. The Company`s core competence is isolation of bacterial and human DNA from difficult clinical samples, and the Company has established a solid market share in the Scandinavian market for sexually transmitted infections. The company has similar applications for Tuberculosis and MRSA. An application for respiratory pathogens is under development. NorDiag is also developing a test that shall contribute to early diagnosis of colorectal cancer. NorDiag was founded in 2003 and has its headquarters in Oslo - Norway. The Company has offices and laboratories in Bergen - Norway, Stockholm - Sweden and West Chester (PA) - USA. The group has 39 employees. NorDiag is listed on Oslo Stock Exchange with the ticker NORD. For further information - www.nordiag.com.
Read the Notice in Norwegian here