Roche HIV Global Access Program expands to include next-generation automated platform solutions

High throughput cobas® systems help optimize workflow for resource-limited settings

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion to the Global Access Program to include the latest high-throughput automated platforms for low and middle income countries. By expanding the Global Access Program for HIV, Roche is now providing its dual-target cobas® HIV test that runs on the cobas® 4800 System and the cobas® 6800/8800 Systems through an affordable price offering for qualifying organizations in 82 eligible countries with the highest disease burden. The cobas® 4800, 6800, and cobas® 8800 Systems provide laboratories with highly efficient solutions for routine molecular testing that offer excellent performance, unmatched flexibility and absolute automation.

“Roche is committed to providing sustainable resources to those countries hardest hit by HIV,” stated Uwe Oberlaender, Head of Roche Molecular Diagnostics. “These improved automated systems offer optimized sample processing so we can begin to work together to rapidly scale up diagnostic and treatment services for all living with HIV, in line with the 90-90-90 1target.”

Roche, 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, has been working to provide actionable solutions towards achieving the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Program expanded in 2015 to include early infant qualitative diagnostics in resource limited settings.

“Roche has once again proven their commitment to reducing barriers to HIV diagnostics access and improving patient well-being,” said Dr. David Ripin, Executive VP of CHAI. “Applying the global access price to the highest throughput, automated molecular platforms available offers countries a significant new tool to support reaching UNAIDS 90-90-90 targets.”

About Roche’s dual-target technology

Rapidly mutating HIV-1 virus can continue to evade quantification with a single target viral load assay. Roche’s dual-target technology for HIV-1 viral load testing is the first technology for viral load testing to amplify and detect two separate regions of a target genome and offer a fully automated and reliable solution for physicians to make informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy. In turn, more accurate results drive better decisions for a positive impact on patients’ lives. By virtue of its design, the dual-target tests, run on the cobas® 4800, 6800, and cobas® 8800 Systems, deliver reliable information for HIV-1 infected patients to physicians in order to make informed treatment decisions. For more information on Roche’s dual-target technology visit www.hivdualtarget.com.

About the cobas® 6800/8800 Systems

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.

For more information about the systems, please visit cobas68008800.com or molecular.roche.com.

About 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.

About HIV-1

According to UNAIDS, in 2014, there were 37 million people living with HIV, with 25.8 million of those living in Sub-Saharan Africa . There are an estimated 2.6 million children under 15 living with HIV around the world, with 2.3 million living in sub-Saharan Africa. That same year 2 million people, including 220,000 children under 15 years, became newly infected with HIV worldwide. In Sub-Saharan Africa, nearly 1 in every 20 adults of all people living in this region are HIV positive 2.

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%3.

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 4.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

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. 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.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine 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 seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 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.

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References:

  1. This goal means that 90% of people living with HIV will know their HIV status, 90% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy, and 90% of all people receiving antiretroviral therapy will have durable viral suppression by the year 2020. Optimizing the use of diagnostics will be critical to achieving the first 90 target, thereby enabling the achievement of the remaining targets.
  2. www.unaids.org/en/resources/campaigns/HowAIDSchangedeverything/slides
  3. www.who.int/hiv/topics/mtct/en/
  4. Lancet. Volume 372, Issue 9635, 26 July 2008-1 August 2008, Pages 293-299.