Roche launches the first fully automated CE marked HIV-1/HIV-2 qualitative diagnostic test on cobas^® 6800/8800 Systems

• Differentiates between HIV-1 and HIV-2 infections to confidently treat patients based on HIV subtype infection
  
• Significant reduction in time to detection is critical in curbing further disease transmission
• Access to testing in rural areas through validated dried blood spot (DBS) collection card

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of the cobas^® HIV-1/HIV-2 for use on the automated cobas^® 6800/8800 Systems in countries accepting the CE mark.  The test provides healthcare professionals with the ability to differentiate HIV-1 from HIV-2, which allows providers to improve treatment options based on subtype infections.

The new HIV-1/HIV-2 qualitative test is validated for plasma and serum to facilitate flexible PCR testing. The dried blood spot (DBS) collection card is also validated as a sample type, enabling access to testing in rural areas.

As the leader in HIV diagnostics, Roche is committed to providing technologies to help providers and patients improve their treatment decisions, 

said Uwe Oberlaender, head of Roche Molecular Diagnostics.  

The ability to more accurately differentiate subtype infection is a significant advancement in controlling and eradiating the HIV/AIDS epidemic.

Current testing methods, which rely on the ability to detect an antibody response, can leave an infected person undiagnosed between two and four weeks.  Because of the greater sensitivity of PCR technology over serology methods, nucleic acid amplification tests (NAT), like the cobas^® HIV-1/HIV-2 test, can reduce this period by up to one week. This significant reduction in time to detection is critical in curbing further disease transmission.  Studies show as many as 50% of new infections are estimated to be transmitted during the acute period between 3 days to 3 weeks of infection.^[1]

cobas^® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas^® 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus (HIV) type 1 (HIV-1) and type 2 (HIV-2) in human serum, plasma, and dried blood spots (DBS). The test includes clinically proven dual target technology for HIV-1 detection.

The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2.  Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. In infants born to HIV-infected mothers and who have maternal antibodies to HIV-1 or HIV-2, the presence of HIV nucleic acid is indicative of active infection. cobas^® HIV-1/HIV-2 Qualitative may also be used to confirm HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens.

Roche announced in 2014, the Global Access Program for increased access to HIV diagnostics. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including CHAI and Centres for Disease Control (CDC), to establish programs that would go beyond providing diagnostic tests. Since its inception, the program has expanded substantially in menu and geographic footprint to provide increased access to HIV diagnostics at affordable pricing for qualifying organizations in 82 eligible countries with the highest disease burden.

Roche also inaugurated the Global Surveillance Program in 1998 at the International AIDS Conference in Geneva. Initially designed to monitor changes in the HIV-1 genomic sequence, the Program and its database have since expanded to include thousands of genomic sequences for multiple viruses, including: HCV, HBV and WNV, in the world’s most relevant geographic regions. The Program’s efforts have played a monumental role in helping to maintain and improve the reliability of molecular assays.

Diagnosing HIV in infants and young children is a major challenge.  Antibody tests are ineffective in children because the mother’s antibodies remain in the child’s system following birth. In fact, antibody tests in infants may yield false positive results for up to 15 months. There are a number of alternate methods available for early diagnosis of HIV infected infants. Many approaches use molecular techniques, specifically detecting the viral DNA and/or RNA, which enables HIV diagnosis as early as six weeks.

Early diagnosis is critical for children infected with HIV. If found HIV positive, they can receive appropriate medical care before they develop significant illness, and can remain healthy despite their infection. If found HIV negative, the mother can get appropriate counseling to ensure their child maintains a HIV-free status.

Accordingly to the World Health Organization (WHO), there were over 36 million people living with HIV around the world. Only 60% of those people know their HIV status.  Just 17 million people are receiving antiretroviral therapy and of those 38% are virally suppressed.  That same year 2.5 million people became newly infected with HIV worldwide. Unfortunately 2.1 million people were newly infected in 2015.

Human immunodeficiency virus (HIV) is categorized into two types, HIV-1 and HIV-2. Worldwide, most HIV infections are HIV-1, whereas HIV-2 largely has been confined to persons in or from West Africa.  HIV-1 and HIV-2 have the same routes of transmission, and both can cause acquired immunodeficiency syndrome (AIDS); however, HIV-2 infections should be differentiated from HIV-1 infections because of the different clinical management.

Diagnosis, highly active antiretroviral treatment (HAART) and viral load tests, 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.

The cobas^® 6800 and cobas^® 8800 systems are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of viral load monitoring, donor screening, women’s health and microbiology. Based on Nobel prize-winning PCR technology, the systems are designed to deliver full automation, increased throughput and faster turnaround time, providing users with greater 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 System and 960 results for the cobas^® 8800 System in an eight-hour shift. Both make 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 walk-away time with minimal user interaction.

Additional molecular assays for use on the cobas^® 6800/8800 Systems include: cobas^® HIV-1, cobas^® HCV; cobas^® HBV; cobas^® CMV; cobas HPV and cobas^® CT/NG plus three next-generation assays for donor screening: cobas^® MPX, cobas^® WNV and cobas^® HEV.

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. 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.