CE Mark for New Real-Time PCR Test for C.trachomatis and N. gonorrhoeae

A new highly sensitive test for the simultaneous detection of the sexually transmitted pathogens Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) has received CE Mark certification, allowing it to be marketed in the European Union. The test is designed for use on the Abbott m2000™, an automated instrument using magnetic particle and real-time PCR technology.

Amplified nucleic acid tests for detection of chlamydia and gonorrhea are accurate and, unlike conventional methods, can be performed non-invasively on urine samples.

The Abbott CT/NG test was developed for use on the Abbott m2000, which uses real-time PCR technology, sometimes referred to as "molecular photocopying." Real-time PCR enables the production of large quantities of DNA from very small samples in a short period of time, making it possible to detect extremely low levels of the bacteria's genetic material. The m 2000 automates all critical steps of the process, from sample preparation to data analysis, allowing laboratories to process molecular tests efficiently and accurately.

The Abbott RealTime CT/NG test will be offered in Europe by Abbott as part of its alliance with Celera Diagnostics. To provide additional testing flexibility for laboratories, the companies will also offer the Abbott RealTime CT assay, a real-time PCR test for the sole detection of Chlamydia trachomatis. Offered along with the tests will be the Abbott multi-Collect Specimen Collection Kit™, a unique laboratory tool for the collection and room-temperature transportation of urine specimens and endocervical, male urethral and vaginal swab specimens.

The new CE certification further expands the menu of tests available on the Abbott m2000 system, which also includes real-time PCR tests for HIV-1 and hepatitis C virus. Additional tests are in development for the system, including methods for detecting hepatitis B virus. Abbott plans to submit the CT/NG test for U.S. regulatory approval in 2006.