Roche Molecular Systems announces the launch of a new clinical laboratory system designed to increase laboratory testing efficiency and to accommodate current and long-term molecular diagnostic needs.
The cobas® 4800 System combines CE-marked in vitro diagnostic tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and human papillomavirus (HPV) testing with fully-automated sample preparation and real-time polymerase chain reaction (PCR) technology.
The tests are designed to detect the 14 HPV high-risk genotypes widely accepted to cause cervical cancer and bacterial DNA associated with chlamydia and gonorrhea infections. By identifying 14 HPV genotypes, the cobas® 4800 HPV test enables immediate identification of the two genotypes (HPV 16 and 18) that put women at highest risk for cervical cancer. Designed to greatly improve laboratory workflow and provide useful information that physicians can immediately act upon, the new cobas® 4800 System is now available in countries that accept CE-Mark.
"The introduction of our new cobas® 4800 System delivers on Roche’s commitment to provide advanced laboratory diagnostics equipment with clinically relevant tests that are designed to provide actionable results for clinicians," said Daniel O’Day, head of Roche Molecular Diagnostics. "This new system also sets the stage for the delivery of additional diagnostic tests in both microbiology and oncology."
The cobas® 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information with increased testing throughput. With a throughput of up to 288 HPV tests or 384 CT and NG tests in eight hours, the cobas® 4800 System is designed to meet the needs of a majority of clinical laboratories. The system combines state-of-the-art sample preparation with Roche’s proprietary real-time PCR technology for the amplification and detection of genetic material (deoxyribonucleic acid or DNA) associated with HPV, CT or NG infections. The intuitive, easy-to-use software integrates sample preparation, amplification and detection, and results management.
"Complete automation of DNA testing for HPV and CT/NG has a lot of advantages, such as standardization, reproducibility, lack of contamination, and less hands-on time," said an early evaluator of the system, Dr. Mateos Lindemann, Laboratory Director at the Hospital Ramon y Cajal in Madrid, Spain. "Roche’s automated cobas® 4800 System is very helpful and can be easily integrated in the work flow of laboratories that must perform a high number of routine tests."