Infants and people living in remote areas to benefit from new sample types compatible with Roche’s HIV test on the cobas 4800 System

• Increases access to early infant HIV testing and monitoring of HIV patients living in remote settings
• Improved accessibility means patient plasma samples no longer need refrigeration during transport to the lab
• Only such card that meets the World Health Organization sensitivity requirement for determining HIV treatment

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the addition of two new sample types for utilization on the cobas^® 4800 System:  Dried Blood Spot (DBS) for qualitative early infant diagnosis (EID) and the cobas^® Plasma Separation Card for quantitative viral load testing.  These solutions further improve access to HIV diagnostic tests.

The inclusion of these additional sample types across all of our molecular diagnostic platforms will expand access to testing in the countries hardest hit by HIV. This is another example of our ongoing commitment to providing life-saving diagnostics in the fight against HIV and AIDS.

Uwe Oberlaender, CEO Roche Molecular Diagnostics

Children born with HIV are particularly vulnerable.  Without reliable early infant diagnosis and treatment,  50% of them will die before their second birthday.1  The use of dried blood spots (DBS) can facilitate PCR testing, and more importantly make sample collection easy, even from the smallest infant.  A quick heel prick is all that’s required to produce an adequate sample.

The cobas Plasma Separation Card is a stable and easy-to-use sample collection device for HIV plasma viral load testing.  By providing a small amount of a patient’s blood from a fingertip, this specially designed card simplifies blood collection and sample transportation - even in areas of extreme heat and humidity - while meeting WHO requirements for determining HIV treatment failure.

The cobas Plasma Separation Card is now available in countries accepting CE-Mark certification, for use with the COBAS^® AmpliPrep/COBAS^® TaqMan^® HIV-1 and cobas 4800/6800/8800 HIV-1 Tests.

The cobas Plasma Separation Card provides the only CE-marked plasma sample collection device which meets the World Health Organization sensitivity standard of < 1000 cp/mL.

The cobas Plasma Separation Card can now be used with the cobas 4800/6800/8800 and the COBAS^® AmpliPrep/COBAS^® TaqMan^® System.  It is also included in the Roche Global Access Program as a solution to help expand access to diagnostics in countries hardest hit by HIV.^*

*Not all products and uses are available in all countries. Please refer to the package insert for applicable intended uses for each individual product.

In 2014, Roche announced, the Global Access Program for increased access to HIV diagnostics. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including UNAIDS, CHAI, Unitaid, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Global Fund, 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 diagnostics at affordable pricing for qualifying organizations in eligible countries with the highest disease burden.

In partnership with the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), Unitaid, the U.S. President’s Emergency Plan For AIDS Relief (PEPFAR) and the Global Fund to fight AIDS, TB and Malaria, Roche has been working to increase access to HIV diagnostic solutions to achieve the UNAIDS 90-90-90 goal to improve people knowing their status, getting on HIV therapy, and suppressing the virus from replicating.

According to the World Health Organization (WHO), there are over 36 million people living with HIV around the world.² Only seventy-five percent of those people know their HIV status.  Just 21.7 million people are receiving antiretroviral therapy and of those, only 47% are virally suppressed.³  In 2017, 1.8 million people became newly infected with HIV worldwide.⁴

The combination of diagnosis, highly active antiretroviral treatment (HAART) and viral load tests which determine the amount of circulating HIV, have all steadily increased life expectancy for people infected with HIV.

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. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 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.