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1 Brad Mears, Managing Director - Africa 26 th August 2014 Atomo Diagnostics Presentation
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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.

Nov 16, 2014

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Health & Medicine

info4africa

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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Page 1: 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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Brad Mears, Managing Director - Africa26th August 2014

Atomo Diagnostics Presentation

Byron Darroch
Here of course - the presenter and date needs to be included
Page 2: 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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AtomoRapid™ HIV Opportunity

Page 3: 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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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.

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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

INTERNATIONALPartnering globally to innovate and deliver products

INTEGRITYWe’re honest, ethical and fair in all our dealings

INNOVATIONWe develop next generation technology for improved usability

Page 5: 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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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

Page 6: 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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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

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Impact of Poor Sensitivity

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Current Generation HIV Test Kits

Uni-Gold Determine BioLineMain 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

Page 9: 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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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

Page 10: 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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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)

Page 11: 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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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™ MalariaMade 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

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NPO / CSI AccessProviding 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

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www.atomoafrica.com

Thank you!

CONFIDENTIAL