Roche, a leader in research-focused healthcare, announced the commercial availability of the cobas HIV-1, HCV and HCV Genotyping (GT) assays in countries accepting the CE mark. These new molecular diagnostic assays increase the available menu on the cobas 4800 System, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions.

The new virology assays offer the latest generation of performance with dual target technology for HIV-1 and dual probe technology for HCV. All of the new virology assays can run simultaneously on the cobas 4800 System, with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value IVD assays, making it the ideal solution for a highly efficient laboratory.

“With the addition of these assays to the cobas 4800 menu, more laboratories have access to advanced virology assays that provide reliable results for confident patient management,” said Roland Diggelmann, COO, Roche Diagnostics.

“As the global market leader, we are also pleased to introduce cobas HCV genotype test which accurately identifies HCV genotypes and helps optimise treatment of hepatitis C patients.”

The assays launched today will be followed in the coming months by the cobas HBV Test, which will complete the portfolio of viral load monitoring and genotyping assays for the cobas 4800 System.

The cobas 4800 System offers improved automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system now has a comprehensive test menu including the cobas HIV-1 Test, cobas HCV Test, cobas HCV Genotyping Test, cobas MRSA/SA Test, cobas HSV 1 and 2 Test, cobas C.diff Test, cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test, and the cobas KRAS Mutation Test.

The three new virology assays can run simultaneously on the cobas 4800 System with two different sample processing volumes for HIV-1 and HCV (200 µL and 400 µL) and only 400 µL for HCV GT streamlining workflow while increasing flexibility for patient sample management.

Cobas HIV-1 is built upon the dual-target assay design from Roche. The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 RNA in a patient's blood.

Cobas HCV employs Roche’s unique dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome and is designed to accurately detect and quantify hepatitis C virus (HCV) ribonucleic acid (RNA) with state-of-the-art sensitivity in order to confirm active HCV infection or assess a patient’s response to antiviral therapy.

Cobas HCV Genotyping is a highly accurate and sensitive real-time PCR-based test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic HCV infection. Identification of the infecting genotype is required before a patient is prescribed antiviral therapy as response to treatment correlates to the HCV genotype.

According to the World Health Organisation (WHO), there were 35 million people living with HIV around the world in 2012. That same year 2.5 million people became newly infected with HIV worldwide. In the most impacted region of Sub-Saharan Africa, nearly 1 in every 20 adults are HIV-positive.

The transmission of HIV from an HIV-positive mother to her child during pregnancy, labor, delivery or breastfeeding is called vertical or mother-to-child transmission (MTCT). In the absence of any interventions, HIV transmission rates are between 15-45 per cent.

Accurate diagnosis, highly active antiretroviral treatment (HAART) and viral load testing, a test to determine the amount of circulating HIV, have contributed to a steady increase in life expectancy for HIV infected people of 13 years.

According to the World Health Organisation, HCV affects some 200 million people globally. Approximately 170 million people are chronic carriers of the hepatitis C virus, and most do not know they are infected. The disease can ultimately result in cirrhosis, liver failure and hepatocellular carcinoma, which together are responsible for hundreds of thousands of deaths each year.