News
Alere Receives CE Mark for Alere™ HIV Combo
POSTED February 23, 2015
Rapid 4th Generation HIV Test Detects HIV 1/2 antibodies and HIV-1 p24 in 20 minutes
Alere Inc.(NYSE: ALR), a global leader in rapid diagnostic tests, today announced it has received CE Marking in Europe for Alere HIV Combo, a rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies. Alere HIV Combo detects all known subtypes and recombinants of the virus more prevalent in Africa, Europe, Asia and Latin America.
Using serum, plasma, fingerstick or venous whole blood specimens, Alere HIV Combo can deliver fast, accurate results in 20 minutes. The test will initially be launched in the UK, France, Switzerland and Spain. Alere is also applying for WHO prequalification to expand availability of the 4th generation HIV point of care tests to Africa. Further global registrations are underway in Asia and will begin in Latin America.
Avi Pelossof, Alere Global President of Infectious Disease said:
“The failure to diagnose acute infections at the point of care represents an important public health problem. The new Alere HIV Combo test will increase opportunities for case finding, particularly in high-risk communities that would not be detected using 2nd and 3rd generation antibody-only tests.”
Alere HIV Combo detects acute infection, which is defined as the interval between the appearance of HIV RNA in plasma and the detection of HIV-1 specific antibodies. Persons with acute infection may be up to 10 times more likely to transmit HIV than individuals with established infection. With use of Alere HIV Combo, HIV can be detected earlier, facilitating fast and appropriate linkage to care.
Including the new addition of Alere HIV Combo, Alere offers diagnostic solutions for the complete continuum of HIV care from initial screening and diagnosis to staging and ongoing monitoring.
Note: Alere HIV Combo is not approved for sale in the U.S. Alere Determine™ HIV-1/2 Ag/Ab Combo is CLIA-waived and available in the U.S.
Alere to Support Organisation of African First Ladies Against HIV/AIDS (OAFLA) in New Effort to End Mother-to-Child Transmission of HIV and Syphilis
POSTED October 10, 2014
100,000 HIV/Syphilis Duo Rapid Tests Donated to African First Ladies to Launch OAFLA’s Push to Eliminate Mother-to-Child Transmission of HIV and Syphilis in Their Countries
Representatives from the Organisation of African First Ladies Against HIV/AIDS, UNAIDS, the International Planned Parenthood Federation (IPPF) and Alere (NYSE: ALR), the world leader in rapid HIV screening and diagnostics products, called for intensified efforts to increase awareness of HIV status in young people, reduce the spread of HIV/AIDS on the continent and, in particular, eliminate mother-to-child transmission of HIV.
At the “African First Ladies Advocating for Health” conference held in New York on 23 September, 2014, Alere announced that it will initially donate 100,000 HIV/Syphilis Duo Rapid tests to countries in Africa to support OAFLA’s efforts to reduce mother-to-child transmission of HIV/AIDS and syphilis, help pregnant women and adolescent girls know their HIV status and reduce child mortality in the continent.
Representatives of the OAFLA pictured at the conference
Namal Nawana, Alere Interim CEO said:
“We are honored to support Africa’s First Ladies in their renewed effort to reduce maternal and child mortality, end mother-to-child HIV infections, and work towards the elimination of congenital syphilis.”
New Alere™ q Point-of-Care Early Infant Diagnosis Test Prototype Accurately Detects HIV in Infants with High Sensitivity and Specificity in Primary Health Clinics in Mozambique.
POSTED July 15, 2014
Alere Inc. (NYSE: ALR) today announced the publication of a study demonstrating the viability of accurate and rapid HIV screening among infants at the point of care (POC). The study was conducted in five clinics in Maputo, Mozambique, with the prototype of Alere’s new POC nucleic acid test, the Alere™ q HIV-1/2 Detect assay. Results of the study have been published ahead of print in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).
Willem Pretorius, Global Product Manager – HIV Care, Alere said:
“Results of this study suggest that point-of-care early infant diagnosis is clinically feasible when administered by non-laboratory personnel, can improve access to screening and treatment, and can help keep people who initiate therapy retained in care.”
Alere Determine™ HIV-1/2 Ag/Ab Combo now available in the U.S.
POSTED October 30, 2013
Alere Inc. (NYSE: ALR), the world’s leading provider of point-of-care rapid diagnostic and health information solutions, has announced the immediate U.S. availability of the Alere Determine™ HIV-1/2 Ag/Ab Combo test, the first U.S. Food and Drug Administration (FDA) approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.
The Alere Determine HIV-1/2 Ag/Ab Combo test is FDA-approved to be sold in the United States as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device. The test simultaneously detects free HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. The test can be used by trained professionals in healthcare settings to identify HIV-infected individuals.
Alere Determine HIV-1/2 Ag/Ab Combo is currently available to all health facilities and laboratories that are licensed to conduct tests of moderate complexity under the CLIA program. Alere Determine HIV-1/2 Ag/Ab Combo test is currently undergoing CLIA-waiver studies to demonstrate its ease of use, safety and accuracy. In the fourth quarter of 2013, Alere anticipates submitting to the FDA its application to categorize Alere Determine HIV-1/2 Ag/Ab Combo as a CLIA-waived test, so it can be made widely available in physician offices and public health settings.
Learn MoreJoin us at the International AIDS Society Conference
POSTED June 26, 2013
Join us at the International AIDS Society Conference
From 30 June – 03 July 2013, join Alere at the 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur, Malaysia.
Visit Alere at booth #201 to learn more about our innovative diagnostic products that are revolutionising HIV chronic disease management at the point-of-care.
Be among the first to see a preview of the Alere™ q HIV-1/2 Viral Load assay, the world’s first point-of-care method for HIV-1 and HIV-2 viral load monitoring and molecular HIV diagnosis.
Making the HIV Spend More Efficient – How POC testing can contribute towards health economics improvements
POSTED April 24, 2013
In this webisode, Tienie Stander, CEO of Hexor, speaks about the economic model developed to demonstrate the impact that point-of-care technologies can have on the HIV treatment cascade.
Arguing that we can make the HIV dollar spend more efficient by focussing on health system improvements such as point-of-care, the model demonstrates that POC testing could contribute towards a reduction in population level viral load which could translate into significant public health and economic improvements.
Point-of-care CD4 testing is a strategy that is cost saving and promotes efficiency in scarce health care resource use. These findings were recently presented at the South African HIV Clinicians Society Conference.
Alere Awarded Gates Foundation Grant for TB and HIV Projects
POSTED April 19, 2013
In an exciting development for the future of point-of-care TB and HIV testing Alere has been awarded a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill & Melinda Gates Foundation. The $21.6 million grant will fund the development of a tuberculosis assay, which will be designed for use in both resource-constrained and well-resourced settings.
In addition, the Gates Foundation will provide below-market loans of up to $20.6 million for the expansion and scale up of Alere’s manufacturing facilities in Jena, Germany for both the POC TB Nucleic Acid Test and the POC HIV Viral Load Test currently in the final stages of development.
Bill Gates, co-chair of the Bill and Melinda Gates Foundation said:
“Alere has a track record of diagnostic innovation and leveraging cost-effective technologies to improve health outcomes for individuals living with HIV in the most remote parts of the world. The Gates Foundation has put its support behind the company to apply these same principles in addressing the TB epidemic and potentially saving millions of lives,”
Package Inserts & Product Brochures Now Available on AlereHIV.com
POSTED February 25, 2013
Package Inserts, User Guides and Product Brochures are now available for download on AlereHIV.com.
If you are in need of a Package Insert, User Guide or Product Brochure for any of the products in the AlereHIV Chronic Disease Management portfolio, simply visit the Specifications page for your product of interest and you will be able to download these items for immediate use.
Alere Pima™ CD4
Visit the Alere Pima™ CD4 Specifications page for access to
- Product Brochure
- User Guides
Alere Determine™ HIV-1/2 Ag/Ab Combo
Visit the Alere Determine™ HIV-1/2 Ag/Ab Combo Specifications page for access to
- Product Brochure
- Package Inserts
Alere Determine™ TB LAM Ag
Visit the Alere Determine™ TB LAM Ag Specifications page for access to
- Product Brochure
- Package Inserts
Alere Pima™ CD4 in Zimbabwe – with Dr Gary Blick
POSTED February 7, 2013
In the latest episode from AlereHIV.com, Dr Gary Blick, President of World Health Clinicians, talks about the pilot program WHC ran in rural Victoria Falls, Zimbabwe with the Ministry of Health.
Using rapid HIV screening tests and the Alere Pima™ CD4 test, they were able to provide HIV infection status and a CD4 count in less than 1 hour, an outcome not available in the developed world.
The portability of the Pima™ allowed Gary and his team to conduct house-to-house CD4 testing outside the clinic, reaching patients who could otherwise be lost to follow up. When the clinic lost power for 3 ½ hours, the team was able to seamlessly switch to the in-built battery and continue their CD4 testing.
Point-of-Care CD4 Testing – Let’s Get On With It! – with Professor Linda-Gail Bekker
POSTED December 1, 2012
In this interview Professor Linda-Gail Bekker from the Desmond Tutu HIV Foundation (Cape Town, South Africa) argues that no HIV test should be provided without a CD4 cell count attached.
The provision of immediate CD4 cell counts has enabled patients to more quickly and efficiently link to care, start anti-retroviral treatment earlier and reduce the rate of mother to child transmission.
With HIV now a treatable disease, the focus needs to shift to cutting down the time to diagnosis and moving patients quickly onto the treatment components.
