06 Dec PRESS RELEASE: Expert Review Panel for Diagnostics approves Atomo HIV Self Test for procurement by Unitaid and the Global Fund
Sydney, Australia, 7 December 2017 | Atomo Diagnostics, the world leader in integrated point-of-care rapid diagnostic devices, announced today that its Atomo HIV Self Test has been confirmed as eligible for procurement by organisations entitled to access Global Fund and Unitaid resources.
- Atomo HIV Self Test confirmed as eligible for procurement with Global Fund resources
- The approved product is a rapid, lateral flow in vitro qualitative immunoassay for the detection of antibodies to HIV Type 1 & Type 2 in human whole blood.
- Designed specifically for home use, this easy-to-use rapid HIV test gives an accurate result in minutes from a single drop of blood.
- Detects HIV antibodies earlier than 2nd generation competitor tests.
The world’s only integrated HIV self-test device, the Atomo HIV Self Test has been approved by the World Health Organisation’s Expert Review Panel for Diagnostics (ERP-D), a special process determined by Unitaid and the Global Fund to expedite access to innovative diagnostic products in advance of approvals through the WHO prequalification process.
Recognised by the expert panel as an innovative diagnostic product, the Atomo HIV Self Test can now be procured by organisations accessing Global Fund and/or Unitaid funding for HIV self-test pilot programs which empower individuals to take control of their own health.
Following on from its recent CE Mark approval, which enables Atomo to market the product in Europe, the ERP-D approval will facilitate further expansion and commercial roll-out of the product in low- and middle-income countries (LMICs).
“We are delighted that the Expert Review Panel for Diagnostics has included the Atomo HIV Self Test on the Global Fund procurement list,” said John Kelly, Founder and Chief Executive Officer of Atomo Diagnostics. “This will enable further expansion of HIV self-testing beyond the private sector and into the growing global health sector, and will support programs aimed at ensuring early diagnosis of HIV.”
Designed to be used at home, the test provides improved in-field diagnostic performance when compared to other multi-component HIV test kits. When used by untrained self-test users in the field, the Atomo HIV Self Test demonstrated 100% concordance to laboratory results in independent studies, making it the best performing self-test approved to date. Additionally, as a 3rd generation test, the Atomo HIV Self Test can detect HIV antibodies earlier than established 2nd generation competitor tests.
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ABOUT ATOMO DIAGNOSTICS
Atomo Diagnostics is a medical device company, based in Sydney, Australia, with corporate offices in the UK and South Africa. The company specialises in the design, development and commercialisation of innovative rapid diagnostic test (RDT) solutions for use with capillary blood samples, including the Atomo HIV Self Test and AtomoRapid HIV (1&2) professional use RDT.
Atomo’s refreshing, user-centered approach to design and willingness to reimagine what has gone before has led it to create products that are simpler to use and that help prevent common user errors associated with standard RDT kits. The recipient of multiple international awards for design and innovation, Atomo’s all-in-one platform devices put the end user first and make it easy to test and screen for a range of infectious diseases and chronic conditions.
As well as commercialising products in its own brand and working with distribution partners internationally, Atomo provides OEM product development services to specialist diagnostic companies worldwide.
ABOUT THE ATOMO HIV SELF TEST
Designed specifically for ease-of-use in the hands of lay users, the integrated Atomo HIV Self Test consists of a 3rd generation HIV test strip in a handheld device that incorporates a sterile safety lancet and unique blood collection and delivery system. The test is performed by delivering a small drop of capillary blood from a finger prick onto the test strip, and then applying drops of chase buffer (diluent). Within minutes, a control line will become visible on the test strip to indicate that the test has worked. A second line – the test line – will only become visible if the applied sample contained antibodies to HIV.
For more features and benefits download the Product Brochure >
For further information please contact:
|At the Company||Media contact|
+61 (0)2 9099 4750
Sue Charles / Gemma Harris
+44 (0) 20 7866 7860