Roche launches next-generation viral load testing assays for new molecular diagnostic platforms in markets accepting the CE mark

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of the cobas® HIV-1 and cobas HCV assays for use on the cobas 6800/8800 Systems—expanding the menu on the newest molecular diagnostic platforms from Roche with next generation viral load monitoring assays. The new assays offer the high performance that clinicians depend on to manage the treatment of patients infected with Human Immunodeficiency Virus (HIV-1) or Hepatitis C (HCV).

“The cobas 6800/8800 Systems represent the next generation of molecular diagnostic instruments that offer unparalleled performance, unmatched flexibility and absolute automation,” said Roland Diggelmann, COO of Roche Diagnostics. “By virtue of their design and clinical utility, the cobas HIV-1 and cobas HCV tests set new industry standards for viral load assays, delivering on Roche’s commitment to provide new diagnostic tools to advance the medical community’s understanding about viral disease and improve the ability to treat patients.”

The assays launched today will be followed in the coming months by the cobas CMV and cobas HBV assays, which will complete the primary portfolio of viral load monitoring assays for the cobas 6800/8800 Systems. This viral load portfolio on the cobas 6800/8800 Systems will provide laboratories with improved productivity and the ability to deliver results for rapid clinical decisions.

The cobas HIV-1 and HCV assays and the cobas 6800/8800 Systems are commercially available in markets that recognize CE-Mark and are not currently available in the United States.

The cobas 6800 and 8800 Systems are fully automated solutions designed for blood donor screening, viral load monitoring, women’s health and microbiology testing. They are available in medium and high throughput models, respectively. Based on the Nobel-prize winning PCR technology, the systems are designed to deliver increased automation and throughput with shorter time to results, providing users with greater testing flexibility to increase overall workflow efficiencies.

The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas 6800 and 960 results for the cobas 8800 in an 8 hours shift. Both systems allow for mixed batching, making it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800) and four hours (cobas 8800) of “work-away” time* with minimal user interaction.

For more information about the systems, please visit www.cobas68008800.com.

* May vary based on workflow demands

Assays for viral load monitoring

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 ribonucleic acid (RNA) with state-of-the-art sensitivity in order to assess a patient’s response to antiviral therapy.

Assays for donor screening

cobas MPX is a real-time PCR multiplex test covering five critical viral targets: HIV-1 Group M, HIV-1 Group O, HIV-2, HCV and HBV, from a single sample. It offers real-time detection and identification of HIV, HCV and HBV, eliminating both the need for discriminatory testing and the potential for discrepant results. Plus, the dual-target approach with amplification of separate regions of HIV-1, and dual probes for HCV, improve coverage of new virus variants.

cobas WNV is a real-time PCR test for West Nile virus (WNV) that is highly sensitive for both WNV lineages 1 and 2. It also provides broad coverage of other flaviviruses that cause transfusion-transmitted infectious diseases.

cobas HEV is a real-time PCR test for hepatitis E virus (HEV), providing broad coverage of all 4 major HEV genotypes.

According to the World Health Organization (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.1 For the most impacted region of Sub-Saharan Africa nearly 1 in every 20 adults or 69% of all people living in this region are with HIV positive.

Diagnosis, highly active antiretroviral treatment (HAART) and viral load testing—testing to determine the amount of circulating HIV—have contributed to a steady increase in life expectancy for HIV infected people of 13 years.2

According to the World Health Organization, 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.

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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1 The UNAIDS Report on the Global AIDS Epidemic 2012.

2 Lancet. Volume 372, Issue 9635, 26 July 2008-1 August 2008, Pages 293-299.