Novel solutions contribute towards scale up efforts for HIV diagnosis and monitoring.
Today, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced at the 20th International AIDS Conference in Melbourne, Australia a simple, innovative method in development for collecting, transporting and storing patient samples in resource-limited settings. The abstract presented at the Conference, entitled “A simple method to elute cell-free HIV from dried blood spots improves the ascertainment of virologic suppression,” provides information for clinicians to more confidently monitor HIV viral load and determine the treatment response of patients in resource-limited settings to ensure immediate medical care before they develop significant illness.
“As a leading healthcare company, we believe Roche has a social responsibility to provide care where access is limited. This improved technology makes it easy to collect and transport samples, for viral load testing from even the most rural area,” stated Dr. Paul Brown, Head of Roche Molecular Diagnostics. “With this new solution from Roche, we are reiterating our commitment to healthcare solutions that make a real difference for patients.”
Protocol Enchances New Assay for Early Infant Diagnosis
In December 2013, Roche received CE Mark certification for the dual-target HIV-1 qualitative test,1 v2.0 which works with both plasma and DBS collection cards to facilitate PCR testing. More importantly, the test allows for the early determination of HIV status for infants as early as six weeks of age.
“The DBS collection card along with highly sensitive and accurate early HIV infant diagnostics are required for timely antiretroviral treatment to save the lives of HIV-infected babies across many African countries”, stated virologist Gert U van Zyl, MB, ChB, MMed, FCPath at Stellenbosch University in South Africa.
Innovation in Centralized and Decentralized Testing
As part of a commitment to ongoing innovation, Roche is developing new HIV testing solutions that cover the spectrum of testing from the centralized laboratory to point of care settings.
Two new platforms will be launched later this year that are specifically designed to meet the needs of medium and high throughput laboratories. “The cobas® 6800/8800 Systems will revolutionize the way labs think and work, because they provide absolute automation, unparalleled performance and unmatched flexibility,” stated Dr. Brown. Along with the launch of the cobas® 6800/8800 Systems will come several assays for virology labs including HIV, HCV, HBV and CMV.
Additionally, with the recent acquisition of IQumm, Roche is continuing the development of the Liat™ (Laboratory-in-a-tube) analyzer and assays which can perform rapid molecular diagnostic testing in a point of care setting, closer to patients and with minimal training. With the Liat™ analyzer and assays, patients will benefit from on-the-spot and accurate diagnoses, which will allow healthcare professional to make rapid, informed treatment decisions in a range of settings.
About Early HIV Infant Diagnosis
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 in less than 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.
About Roche’s Tradition of Commitment to HIV Care
Roche has been at the forefront of achievements for HIV and a global market leader in HIV viral load testing. In 1998, at the International AIDS Conference in Geneva, Roche inaugurated the Global Surveillance Program. 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.
Roche reinforced our commitment in 2002 with the AmpliCare Initiative. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including the Clinton Health Access Initiative (CHAI) and Centres for Disease Control (CDC), to establish programs that would go beyond providing diagnostic tests. The AmpliCare Initiative was a proactive response to the enormous humanitarian challenge of HIV/AIDS and TB. Since its inception in 2002, the programhas increased access to HIV viral load tests at substantially reduced prices in sub-Saharan Africa and countries where the disease burden is highest.
About the Roche dual-target HIV-1 Qualitative Test
The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acid amplification test for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasma or dried blood spots using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The dual-target test is designed for broad HIV-1 detection in the presence of naturally-occurring and drug-induced mutations.
The test is a diagnostic test, indicated for individuals who are suspected to be actively infected with HIV-1. Detection of HIV-1 TNA is indicative of active HIV infection. Infants born to mothers infected with HIV-1 may have maternal antibodies to HIV-1, and the presence of HIV-1 nucleic acid in the infant indicates active HIV-1 infection. In adults, the test may be used as an aid in the diagnosis of HIV-1 infection.
Accordingly 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.2 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.
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%.
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.3
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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For media inquiries please contact:
Bob Purcell, Roche Molecular Diagnostics, 888-545-2443
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Silvia Zucca, Italy, +39 039 2817 612
Reeta Bhatiani, UK, +44 1444 256922
Francisco Aguilar-Alvarez, Spain, +34 93583 4011
Eudes de Villiers, France, +33 4 76 76 31 26
Banu Kutlu, Turkey, 00902123060606
Harald Borrmann, Switzerland, +41 41 799 6253
- The test is called COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, v2.0
- The UNAIDS Report on the Global AIDS Epidemic 2012.
- Lancet. Volume 372, Issue 9635, 26 July 2008-1 August 2008, Pages 293-299.