Roche Unveils the cobas® 6800 and cobas® 8800 Systems at International Congresses

Roche is proud to unveil the fully integrated, highly automated cobas® 6800 and cobas® 8800 Systems, the next generation of molecular diagnostic platforms that will revolutionize the way laboratories operate.

The cobas® 6800 System, which is being previewed right now for the first time at EuroMedLab in Milan – May 19th, and the higher throughput cobas® 8800 System, debuting at the International Society for Blood Transfusion June 2 in Amsterdam, offer unparalleled flexibility, automation, throughput and speed. These Systems can process 300 and 1,000 tests respectively, in 8 hours with the first 96 results being available in just over 3 hours.

Compared to the competition, the cobas® 6800 and 8800 Systems truly are in a class of their own. Both Systems allow for fully flexible sample testing workflow through random access – and the ability to test multiple assays in each run. In addition, the cobas® 6800 and 8800 Systems have been designed for reliability, with full process controls to meet the future needs of molecular laboratories. 

During the first 6 months of the cobas 6800 System CE launch, several assays will be available for virology labs – HIV, HCV, HBV and CMV – and for blood screening labs – MPX (HIV/HCV/HBV), WNV, HEV and DPX (B₁₉V Quant/HAV Qual). Post launch, the system will support additional assays including HPV, CT/NG and a utility channel for user-defined aps.

Roche Molecular Systems – cobas^® 6800/8800 Systems

Roche automated solutions provide a continuum of innovation towards fully automated systems with increased flexibility. Built on a heritage in molecular diagnostics and enhanced with extensive customer collaboration and input, cobas® systems are enabling laboratories to experience a more efficient operational workflow than they have ever experienced before. 

The cobas^® 6800/8800 Systems are new platforms based on Nobel-prize winning PCR technology for virology, blood screening, HPV and CT/NG testing.  The system comes in two sizes – large and very-large throughput capacity – and was developed to deliver increased automation and throughput, with minimal user intervention and improved quality control.

The large volume cobas® 6800 System can process up to 300 molecular diagnostic tests in 8 hours; while the very-large volume cobas® 8800 System can process up to 1,000 molecular tests in 8 hours.  Both systems are easy to use, providing results in 3 hours while allowing up to 4- and 8-hour walk-away time.   For compatibility and convenience, the system provides uni- and bidirectional LIS interfacing using an HL7 protocol.  

These reliable and highly flexible systems are equipped with anti-contamination measures, RFID tracking capability and designed to accommodate continuous sample loading, regardless of target test type (no batching required). They also provide the ability to run up to three different unique assays from one sample. 

TECHNOLOGY

The scientists of Roche Molecular Diagnostics (RMD) are committed to the advancement of the science of Polymerase Chain Reaction (PCR) to meet ever-changing global medical needs. With innovation as our motivation, RMD has pioneered the development of both standard PCR and real-time PCR techniques. We have regularly introduced new capabilities and improvements based on the company’s Nobel prize-winning PCR technologies.

Real-time PCR together with AmpEraseÒ Enzyme reduces the risk of cross-contamination between samples. With its dynamic range, a single real-time PCR assay can detect and accurately quantify as little as a few virus particles and up to millions, enabling important clinical advancements, such as highly accurate viral load testing critical to proper assessment of disease progression and response to therapy for HIV and hepatitis.

Roche Blood Screening & Virology Testing

Roche is a leader in the global blood and plasma nucleic acid-based test (NAT) screening market. NAT screening enables earlier detection of active viral infections than conventional antibody or antigen assays. Roche’s real-time PCR-based nucleic acid assays have been used since 1998 to screen blood and plasma products. Currently, more than 250 blood banks worldwide use Roche’s automated cobas s 201 system.

RMD’s automated platforms and broad portfolio are focused in the areas of virology, blood screening, HPV, genomics and oncology, microbiology and sexually transmitted infections. RMD’s clients include researchers, physicians, patients, hospitals, laboratories and blood banks around the world.

Roche Molecular Diagnostics provides automated tests to directly detect and quantify viral load of hepatitis B and C, HIV, along with tests for cytomegalovirus (CMV). The cobas® TaqScreen DPX Test uses multi-dye, real-time polymerase chain reaction (PCR) technology which allows for the simultaneous detection and identification of individual viral targets without the use of additional discriminatory tests. A further innovative aspect of this test is that it facilitates quantification of the parvovirus B19 virus while detecting extremely low levels of HAV.

DISEASES

Human Immunodeficiency Virus (HIV-1)

Highly active antiretroviral treatment (HAART) and viral load tests, such as the COBAS® AMPLICOR HIV-1 MONITOR Test, a test to determine the amount of circulating HIV, have contributed to a steady increase in life expectancy for HIV infected people by 13 years.[1]

Hepatitis B Virus (HBV)

According to WHO, an estimated two billion people worldwide have been infected with the hepatitis B virus and more than 240 million have chronic liver infections. About 600,000 people die every year due to the acute or chronic consequences of hepatitis B.

Hepatitis C Virus (HCV)

According to WHO, every year 3–4 million people globally are infected with the hepatitis C virus and about 170 million people are chronically infected and at risk of developing liver cirrhosis and/or liver cancer. More than 350,000 people die from hepatitis C-related liver diseases every year.

West Nile Virus (WNV)

West Nile virus (WNV) is a potentially serious illness, especially for those with compromised immune systems. In 2003, when blood transfusion-associated transmission (TAT) of WNV infection marked the emergence of a new threat to the US blood supply, blood-collection agencies implemented new, investigational WNV nucleic acid–amplification tests (NATs) such as the cobas® TaqScreen West Nile Virus Test, to screen all blood donations and identify potentially infectious donations for quarantine and retrieval.

Parvovirus B19 and hepatitis A Virus

Parvovirus B19 (human parvovirus B19) infects only humans. Fifth disease, a mild rash affecting children, is the most common illness caused by parvovirus B19. It can cause painful or swollen joints (polyarthropathy syndrome) and cause the body to temporarily stop making new red blood cells. This can lead to transient aplastic crisis, hydrops fetalis, congenital anemia, pure red cell aplasia or persistent anemia.

According to WHO, hepatitis A Virus (HAV) causes about 1.5 million cases of clinical hepatitis each year. HAV infection produces a self-limited disease that does not result in chronic infection or chronic liver disease.  However, 10%–15% of patients might experience a relapse of symptoms during the 6 months after acute illness.

Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG)

According to the European Centre for Disease Prevention and Control, CT is the most frequently reported bacterial sexually transmitted disease (STD) in many countries in Europe and the second most leading cause of STDs worldwide. Since nearly half of CT infections are asymptomatic, many cases go undetected and untreated. The consequences of an untreated chlamydial infection can be severe, leading to urethritis, conjunctivitis or infertility, and blindness, among other conditions.

NG is a sexually transmitted disease caused by the bacteria Neisseria gonorrhea. Global incidence estimates from the WHO of gonorrhea is 62 million infected people annually.  NG infections in men can lead to urethritis or epididymitis, and in women can lead to endocervical infection or pelvic inflammatory disease, among other conditions.

Human Papillomavirus (HPV) and Cervical Cancer

Persistent infection with HPV is the principal cause of cervical cancer. In 2008, WHO estimated there were 529,000 new cases and 274,000 deaths due to cervical cancer. More than 85 % of cervical cancer deaths are in developing countries, where it accounts for 13% of all female cancers.

Cytomegalovirus  (CMV)

CMV is the most common viral infection in solid organ transplant recipients, transmitted through direct infection or by reactivating latent virus in the patient. Between 50 – 80% of all people in the US become infected with CMV. Although healthy persons usually have few symptoms at the time of initial infection, after infection the virus remains in a latent state in the body for the rest of a person’s life.