MRC/info4africa KZN Community Forum | 26 August 2014 | Improved quality when going to scale - The need for improved HIV diagnostics & ensuring access to care.
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Topic: Improved quality when going to scale - The need for improved HIV diagnostics, and ensuring access to care. Speaker: Mr Brad Mears - Managing Director of Atomo Diagnostics As South Africa overcomes the battle against HIV, diagnostic tools, systems and tests need to perform at an improved rate, in-field. Proper diagnosis opens the pathway for entry into the healthcare system, and successful health outcomes for patients on ARV treatment. The poor in-field performance of some diagnostic tools has led to the under-diagnosis of patients presenting for testing. A new diagnostic platform that Atomo is bringing to market aims to remove most of the human error when tests are conducted. As Managing Director for Atomo Diagnostics, and with a long history of working in the realms of HIV and AIDS, Mr Mears will showcase the company’s new HIV diagnostics platform. As a company, Atomo is a start-up diagnostics company, which seeks to bring new and innovative products to market.
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MRC/info4africa KZN Community Forum | 26 August 2014 | Improved quality when going to scale - The need for improved HIV diagnostics & ensuring access to care.
- 1. 1 Brad Mears, Managing Director - Africa 26th August 2014 Atomo Diagnostics Presentation
- 2. 2 AtomoRapid™ HIV Opportunity The world’s most convenient, reliable RDT for HIV diagnosis Utilises a WHO Pre-qualified HIV Test strip Winner of Anthill Smart 100 Top Australian Innovations for 2014 Finalist in the Medical Design Excellence Awards 2014 Excellent diagnostic performance - 100% Sensitivity over two separate NICD evaluations Integrated Simple Reliable
- 3. 3 Company Introduction Atomo Diagnostics is a multi award-winning innovator in rapid diagnostics Atomo develops and commercialises innovative solutions that substantially improve in-field and at-home-based testing. Our award-winning AtomoRapid™ platform was designed with ease of use, performance and convenience as primary considerations. We are pleased to offer the African market AtomoRapid™ HIV & AtomoRapid™ Malaria, the world’s first integrated rapid tests for these diseases.
- 4. 4 We believe in delivering impactful innovation that allows for accurate assessment and treatment of everyone’s health Atomo’s Core Values IMPACT We seek to transform health outcomes worldwide INTERNATIONAL Partnering globally to innovate and deliver products INTEGRITY We’re honest, ethical and fair in all our dealings INNOVATION We develop next generation technology for improved usability
- 5. 5 There are significant in-field limitations with current ‘bits in a box’ RTD’s • Multiple devices required • Many steps with a lot of manual handling • Onerous training & in-field QA • Errors common (Between 3% - 10% in professional use) • Unsuited to Community / Self test applications (large errors) Issues with existing RDT’s
- 6. 6 Sensitivity Case Study Wolpaw et al reported in-field testing sensitivity of 68.7% - 95.1% *Study is based on testing in public service clinic in Cape Town and involved 3000 samples 60% 70% 80% 90% 100% Claimed Performance Worst In-field Performance Std In-field Performance Improved In-Field Performance
- 7. 7 Impact of Poor Sensitivity
- 8. 8 Current Generation HIV Test Kits Uni-Gold Determine BioLine Main Features Convenient - All in One; Ease of Use; Always delivers correct blood volume Established in the market Established in the market Lower volume of blood, Cost Competitive Required Blood Volume 10µL 60µL 40µL 20µL Simplicity Safety lancet, blood collection and test all integrated into one device Test provided as multiple components in a box Test provided only, ancillary equipment purchased separately, including diluent Test provided as multiple components in a box Settings Suitable for both Clinic and community testing Suitable for clinic use only Suitable for clinic use only Suitable for clinic use only Ave. Sales Price US$1.50 - US$1.85 US$.1.60 – US$2.80 US$0.80 - US$1.25 US$0.60 - US$1.00
- 9. 9 AtomoRapid™ HIV uses a third generation HIV 1&2 test strip that has been on the World Health Organisation’s Pre-qualification list for a number of years AtomoRapid™ HIV Performance: • Demonstrates excellent performance in NICD evaluations in South Africa o Sensitivity of 100% and Specificity 99.8% • Two in-field usability studies performed by leading NGO’s show overwhelming user preference for AtomoRapid™ HIV over current test kits
- 10. 10 Excellent! Absolute convenience to the user. Efficiency and ease of use because of the complete kit. (South African G.P.) It was a pleasure to see how excellent your device is working and we are all very impressed. (M.D. - European Diagnostic Company) I mentioned that the amount of blood drawn can be a problem and this solves that. It is very easy to use, no sucking up of the blood or place for mistakes. (South African Clinic nurse) AtomoRapid™ HIV Testimonials I mentioned that the amount of blood drawn can be a problem and this solves that. It is very easy to use, no sucking up of the blood or place for mistakes. (South African Clinic nurse) What Atomo brings to the field is an ease of use and use reliability which is critical. My prevention and care centres are all excited and happy to be utilising the AtomoRapid HIV for HIV diagnoses. (Professor Linda-Gail Bekker - The Desmond Tutu HIV Centre)
- 11. 11 AtomoRapid™ Malaria utilises a leading test combining HRP2 and pLDH antigens in the test to detect all four common strains of malaria • Test is manufactured in Cape Town, South Africa AtomoRapid™ Malaria Made in South Africa Performance Third party European evaluations* • Sensitivity (Non-P.f. malaria): 64/65 (98.5%) • Sensitivity (P.f. Malaria): 270/273 (98.9%) • Specificity: 316/317 (99.7%) * in accordance with WHO standards (>95% sensitivity) for the detection of falciparum malaria infections when the parasitomia is minimum 100p/µl
- 12. 12 NPO / CSI Access Providing affordable access to AtomoRapid™ HIV & AtomoRapid™ Malaria to improve public health access via public health, NPO & CSI contracts Benefits: • Allows Government, NPO’s & CSI’s to procure product at preferential pricing • Maximises the positive impact the these products can have in disadvantaged communities • Reduces in field errors and improves the reliability & effectiveness of in-field testing programs • Enables Atomo and its partners to better support a broad range of CSR initiatives Companies can invest in the wellness of their communities, thereby improving their productivity and better meeting their public CSR objectives Tests are accessed at discounted prices, thereby improving access to healthcare
Editor's Notes
- Over the last twenty years attributes such as usability, convenience, safety and simplicity have become key considerations in the development of successful healthcare products as the market transitions toward consumer driven healthcare. Significant segments of the in-vitro diagnostic (IVD) market have not kept pace with these changes offering a strategic opportunity to types of new product developments. As a result, Atomo has identified a strategic opportunity within this market to develop a next generation of custom healthcare solutions that will address the needs of the rapid test market. The performance of Lateral Flow (LF) tests has been well established in laboratory settings however outside of the lab their use is compromised by the need to use multiple accessories and the difficulty of reliably performing procedures in point of care settings. AtomoRapid is the world’s first integrated blood based lateral flow test product. It replaces the need to use procedural kits requiring multiple devices and significant handling. AtomoRapid does this by offering a simple easy to use reliable test solution that does not require extensive clinical training. Current kits are not intuitive and have a high error rate associated with their use; typically estimated at 5 –10% in professional use applications and up to 50% when used by untrained self test users. In contrast, AtomoRapid offers a simplified procedure involving less handling, less process steps and reduces room for error. AtomoRapid’s generic design enables it to be used across lateral flow based IVD tests, simply by altering the type of test strip that is incorporated in the product during manufacture. This gives it enormous scope across a wide range of clinical and consumer based markets.
- 2010 South African Government HCT Campaign
- A current generation HIV RDT with multiple items needed to carry out a rapid test procedure compared to the integrated AtomoRapid HIV device Problems with Rapid Test Kits Multiple devices required – many user steps requiring significant handling and skill Not intuitive to use Errors common when used in the field - Professional use (3 -10%) Unsuited to Self test applications - error rates of up to 50%
- AtomoRapid HIV and been re-validated by InTec as equivalent to the WHO assessed test and had demonstrated excellent performance during evaluations by the South African National Institute for Communicable Diseases (NICD) in Johannesburg and was performed across two separate production batches. Sensitivity of 100% and 100% Specificity of 100% and 99.6% These two evaluations combined, involved over 500 positive and 500 negative samples During these evaluations, AtomoRapid HIV detected positives after sample titration (dilution) down to 1:160 and 1:640 respectively The product has undergone two in field evaluations in South Africa Foundation for Professional Development – Pretoria Desmond Tutu HIV Foundation – Cape Town Summarise Tutu Clinician feedback!
- Need to include some notes on endorsements and how the product is perceived in the market and with key opinion leaders
- The Medical Diagnostic Malaria test is currently undergoing Round 5 WHO Product Evaluation. Internal verification testing confirms that diagnostic performance of the Medi-Tech malaria test in AtomoRapid matches existing performance in the standard Medi-Tech cassette. The test has demonstrated good performance down to 30p/µl has been demonstrated Atomo intends to complete Process Validation builds in the coming month and has submitted AtomoRapid Malaria for Round 6 WHO Product Evaluation
- Procurement challenges – Atomo has identified a few potential procurement challenges. Some HIV tenders may specify 4th generation HIV tests. These tests have slightly reduced detection windows for newly infected patients, but require large blood volume samples. Fourth generation tests are not typically required for screening latent HIV infections in general populations. They reduce detection windows for newly infected patients by one week, but are expensive and require large blood volume samples making them less user friendly and prone to insufficient blood volume delivery affecting sensitivity Intellectual property infringement – As AtomoRapid™ becomes established as the preferred market solution for rapid testing, imitation becomes a risk. To minimise these risks Atomo has sought effective IP protection, including utility and design patent protection in key markets as well as a trademark for the AtomoRapid™ brand. Atomo has utility patents families relating to: the method of collection and delivery of the blood sample the integration of a buffer storage / delivery mechanism Both patents have been granted in tier 1 jurisdictions with no country as yet rejecting the patent claims (One or other granted in Australia, Singapore, South Korea, New Zealand)