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Roche Launches New Automated Clinical Laboratory System

To increase laboratory testing efficiency and to accommodate current and long-term molecular diagnostic needs

Roche Molecular Systems (Roche) has launched 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 company said that the tests are designed to detect the 14 HPV high-risk genotypes that cause cervical cancer and bacterial DNA associated with chlamydia and gonorrhea infections. By identifying 14 HPV genotypes, the cobas 4800 HPV test enables identification of the two genotypes (HPV 16 and 18).

Designed to improve laboratory workflow and provide useful information for physicians, the new cobas 4800 System, is now available in countries that accept CE-Mark.

The company claims that 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 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 software integrates sample preparation, amplification and detection, and results management.

Daniel O’Day, head of molecular diagnostics at Roche, said: “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. This new system also sets the stage for the delivery of additional diagnostic tests in both microbiology and oncology.”