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Project to support adoption of the io® rapid diagnostic platform into UK sexual health clinics

Bath, UK, 14 August, 2017. Atlas Genetics Ltd., the ultra-rapid Point-Of-Care (POC) molecular diagnostics company, today announces that it has been awarded a two year Innovate UK phase II contract to expand the Sexually Transmitted Infection (STI) test menu for the io® rapid diagnostic platform and support its adoption into UK sexual health clinics.

Valued at approximately £2m, this contract will bring together Atlas Genetics, Aquarius Population Health (a leading independent health economics consultancy) and the Applied Diagnostic Research and Evaluation Unit (ADREU) at St George’s University of London.

This collaboration will enable further research into diagnostic pathways within sexual health and the benefits of the introduction of POC testing, to be demonstrated by the design of a digital value proposition tool. The project will also include the evaluation of the io® rapid diagnostic platform in several UK sexual health clinics and assist the development of Atlas Genetics’ Multi-STI (io® MSTI) test ahead of clinical trials. io® MSTI is a novel multi-pathogen test for Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis and Mycoplasma genitalium.

The io® system is a highly innovative molecular diagnostic platform for the ultra-rapid diagnosis of a broad range of infectious diseases. The system offers a sample-to-answer time of 30 minutes making it possible to carry out infectious disease tests in primary care clinics and physicians’ offices that are as accurate as those carried out in hospital laboratories.

Dr John Clarkson, Chief Executive Officer of Atlas Genetics, said: “We are delighted to have been selected for this substantial follow-on contract. The work being done by this collaboration will enable us to better understand how best to integrate our io® system into UK sexual health clinical practice. Innovate UK’s commitment to introducing new, pioneering approaches to healthcare validates both our technology and our leading role in molecular diagnostics.”

Dr Elisabeth Adams, Managing Director of Aquarius Population Health commented: “We are very excited to collaborate on this Innovate UK funded project. Together with Atlas Genetics, we are developing an innovative digital value proposition tool which we believe will help sexual health clinics in their commissioning and adoption of io® rapid diagnostic platform.”

Dr Tariq Sadiq, Director of the Applied Diagnostic and Research Evaluation Unit at St George’s University of London, added: “This is a highly exciting and innovative approach to better understand and overcome the often complex and substantial challenges to getting cutting-edge technology adopted into the NHS. We believe that there are real benefits to using the io® rapid diagnostic platform as patients will be able to receive the appropriate treatment immediately and thereby reduce onward transmission, and ultimately save the NHS time and money."

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Financing global launch and menu development of Atlas Genetics’ io® molecular testing system

Bath, UK, 23 January, 2017. Atlas Genetics Ltd., the ultra-rapid Point-Of-Care (POC) molecular diagnostics company, today announces completion of its Series D financing, raising $35 million from a syndicate including all Series C Investors and one new investor, Wondfo Biotech. Development of the Atlas Genetics io® system has been completed with the successful CE marking of the Chlamydia trachomatis (CT) test announced in February 2016.  This new Series D equity issue will finance the clinical trials and commercial launch of a second test, for detection of both Chlamydia and Gonorrhoea, planned for regulatory approvals in the US around the end of 2017, as well as further development of additional diagnostics menu.  The financing also provides funding to expand cartridge manufacturing capacity at Bespak, Atlas Genetics’ cartridge manufacturing partner.

The io® system is a highly novel molecular diagnostic platform for the ultra-rapid diagnosis of a broad range of infectious diseases.  The system offers a sample-to-answer time of under 30 minutes making it possible to carry out infectious disease tests in primary care clinics and physicians’ offices that are as accurate as those carried out in hospital laboratories.  It is based on a patent-protected electrochemical sensor technology that combines speed, accuracy and low manufacturing costs.  The fully integrated cartridge contains all reagents and is designed to receive an unprocessed clinical specimen. Each cartridge can detect up to 24 different genetic targets from a single patient sample.  Wondfo Biotech, the new investor, is a well-established Chinese in vitro diagnostic company, with over 1,000 employees based in Guangzhou, Guangdong Province, that develops and manufactures a broad range of diagnostic assays including several POC tests.  Existing investors include Novartis Venture Funds, Consort Medical plc, Johnson & Johnson Innovation - JJDC, Inc., LSP, BB Biotech Ventures, RMI Partners and Technology Venture Partners.  This new financing follows on from the previously announced Series C fundraising of $20 million in January 2015.

Dr John Clarkson, Chief Executive Officer of Atlas Genetics, commented: “We have continued to make excellent progress and are delighted to have raised significant funds to allow us to complete clinical trials, registration and launch in Europe and the US of our flagship product, a combined CT/NG (Chlamydia / Gonorrhoea) test, as well as to further our menu development.  Our system will enable physicians to test and treat patients immediately for what can be distressing conditions.  Immediate treatment enables better antibiotic stewardship and prevents onward transmission, which will help to reduce the associated financial burdens that these infections place on our healthcare systems.  We believe that Atlas Genetics is poised to become a world leader in POC molecular diagnostics and we plan to roll-out new assays in a range of clinical areas over the next two years and beyond.”

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Results are a significant step in creating a new standard in STI molecular diagnostics

Bath, UK, 5 January 2017. Atlas Genetics Ltd (“Atlas Genetics” or the “Company”), the Point-Of-Care (POC) molecular diagnostics company, today announces positive results from a United States beta study for Chlamydia trachomatis (CT) on its rapid io® diagnostic platform.

The study demonstrated the Atlas io® platform’s high sensitivity and specificity, and ability to deliver accurate performance, comparable to laboratory systems, in thirty minutes. The results pave the way for the Company’s combined Chlamydia & Gonorrhoea clinical registration study to be completed later this year, which will bring test and treat solutions for patients one step closer.

The key objectives of this beta site study were to assess the performance of the Atlas Genetics io® rapid, POC PCR test for CT compared to a laboratory nucleic acid amplification test (NAAT), and to evaluate women’s attitudes to rapid testing and willingness to wait for testing results. Dr Lea Widdice at Cincinnati Children’s Hospital conducted the study.

The study indicated that the Atlas Genetics’ io® CT assay had high sensitivity (94.1%) and specificity (99%) in a cohort of 212 women when testing prospective, self-collected vaginal swab samples. The women reported a preference for vaginal samples and a willingness to wait 30 minutes to receive their CT result, if it meant that they could receive treatment before leaving the clinic. Providing the patient with a rapid, actionable test result can improve patient outcomes in a number of ways including:

expediting appropriate therapy;
lowering the risk of antibiotic resistance;
reducing patient pathway costs;
decreasing onward transmission;
and improving the patient experience.

John Clarkson, CEO of Atlas Genetics, commented: “Our aim is to improve patient outcomes by providing healthcare professionals with simple, accurate and rapid solutions to enable the diagnosis of diseases in decentralised settings, such as specialist STI clinics and primary care clinics. Demonstrating the io® platform’s ability to generate high sensitivity and specificity in self-collected patient specimens during a single clinic visit is a significant step in the execution of our strategy to create a new standard in STI molecular diagnostics. We look forward to completing our subsequent combined Chlamydia & Gonorrhoea clinical registration study later this year, bringing test and treat solutions for patients one step closer.”

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CE-marked CT test gives results in 30 minutes

Bath, UK, 02 June 2016. Atlas Genetics Ltd (“Atlas Genetics” or the “Company”), the STI Point-Of-Care (POC) molecular diagnostics company, today notes the major issue of antibiotic resistance for Sexually Transmitted Infections (STIs), as highlighted in the UK Government commissioned anti-microbial resistance report, chaired by Jim O’Neill – ‘Tackling Drug-Resistant Infections Globally’ and recently referenced on the BBC program Newsnight. The O’Neill report recommends that in high income countries health system leaders should ‘support the uptake and use of rapid point-of care diagnostics in primary and secondary care’[1].

The Atlas Genetics io® system, which is CE-marked and cleared for the sale within the European Union for Chlamydia, is the first molecular POC test for a Sexually Transmitted Infection (STI) to enter the market, capable of delivering test results in just 30 minutes. As well as tests for other STIs, Atlas Genetics are developing a range of products, as part of the “Precise” project, in collaboration with St George’s University of London, that will not only detect the presence of STIs but provide invaluable antibiotic resistance information at the same time.

It typically takes patients several days from having a sample taken to receiving their test results. Because of this delay, doctors often treat presumptively and frequently prescribe a strong front-line antibiotic for fear of treatment failure due to resistance, or even the wrong antibiotic based on the patient’s symptoms. The speed of the Atlas Genetics io® system gives doctors the ability to prescribe the appropriate antibiotic immediately.

Dr Chan, Director General of the World Health Organization, said: “Today, antibiotics are rarely prescribed based on a definitive diagnosis. Diagnostics tests can show whether or not an antibiotic is actually needed, and which one. Having rapid, low-cost, and readily available diagnostics is an essential part of the solution to this urgent problem.”[2]

Dr Tariq Sadiq, Chief Investigator of the NIHR invention for innovation (i4i) programme funded “Precise” project at St George’s, University of London, which is developing a POC test for drug resistance with Atlas Genetics commented: “There will be real benefits of using the Atlas Genetics io® as patients will be able to receive the appropriate treatment immediately. In gonorrhoea for example, for the majority of cases there is often no need for injection of very strong front-line antibiotics when more economic antibiotics can effectively treat the problem. Using this more targeted approach means doctors can prescribe the right antibiotic with confidence, reducing the risk of resistance to these newer, stronger antibiotics by sparing their use for when actually needed and potentially generate large savings for healthcare systems.”

John Clarkson, CEO of Atlas Genetics, added: “As highlighted in the O’Neill report, STIs are on the rise and the faster a diagnosis can be made, the faster treatment can be given. This not only benefits the patient but also reduces the burden of unnecessary antibiotic use on the NHS and saves the clinician time and money. We believe that our io® platform will play a critical key role in the future of STI diagnosis.”

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New Multiplex test for Sexually Transmitted Infections (STIs)

Bath, UK, 15th March, 2016. Atlas Genetics Ltd (“Atlas Genetics” or the “Company”), the ultra-rapid Point-Of-Care (POC) molecular diagnostics company, today announces that it has been awarded an SBRI grant from Innovate UK to assist in the development of an ultra-rapid POC multiplex STI test measuring the four most commonly occurring pathogens (Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis and Mycoplasma genitalium) in less than 30 minutes.

Atlas Genetics will develop an ultra-rapid POC stratified medicine diagnostic for patients presenting to Sexual Health Clinics with urethritis, which will allow immediate and accurate selection of appropriate and effective antibiotic treatment. Atlas will be collaborating with the Applied Diagnostic Research and Evaluation Unit at St George’s, University of London and Aquarius Population Health. Key elements of this project include cost-effectiveness modelling of introducing this multi-pathogen test, as well as a study on its potential patient impact. The £150,000 grant will be shared between the three organisations.

John Clarkson, CEO of Atlas Genetics, said: “With our Chlamydia test now approved in Europe and our combined Chlamydia/Gonorrhoea test planned for clinical trials later this year, the next step for Atlas is to develop a multiplex test which covers the majority of pathogens for patients entering sexual health clinics. We are very excited to be working with St Georges and Aquarius Population Health on this important project.”

Dr Tariq Sadiq, Chief Investigator at St George’s, University of London, commented: “This is a very exciting development in the STI world. The diagnosis and treatment of sexually transmitted infections has become very challenging for doctors and this new test will allow for patients to have their precise infection identified to enable treatment with the correct antibiotics, immediately after they see a doctor.”

Dr Elisabeth Adams, Managing Director of Aquarius Population Health, added: “We are thrilled to collaborate on this project and develop evidence to demonstrate the likely costs, benefits and cost-effectiveness of an innovative STI test. Results have the potential to positively impact patient care, increase efficiency within the NHS, and improve antimicrobial stewardship.”

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Approval of Chlamydia test for marketing and sale in Europe

Bath, UK, February 8, 2016. Atlas Genetics Ltd (“Atlas Genetics” or the “Company”), the ultra-rapid Point-Of-Care (POC) molecular diagnostics company, today announces that it has received approval to CE Mark its Chlamydia trachomatis (CT) test to be launched on the Company’s io® platform. By meeting the requirements of the IVD Directive (98/79/EC), the CT test is now cleared for sale within the European Union.

The launch of the io® CT test signals a new era in ultra-rapid molecular diagnostics. This is the first molecular POC test for a Sexually Transmitted Infection (STI) to enter the market, capable of delivering test results in just 30 minutes. With the speed and accuracy of the io® CT product, the testing and treatment of patients within a single, brief visit to the clinic now becomes a reality. The evaluations conducted on the io® CT test demonstrated that performance is equivalent to the gold standard laboratory test and will not be compromised by the transition of testing away from the central laboratory to the POC setting, or by the level of experience of the operator performing the test. The benefit of the io® platform is to provide a rapid result, delivered immediately to the patient which has the potential to improve patient outcomes, decrease onward transmission and reduce healthcare costs.

The Chlamydia test is the first in a pipeline of tests to be launched on the io® platform. Further menu development will include tests for Gonorrhoea, Trichomonas vaginalis and other STIs, for both the European and US markets. Whilst Atlas’s commercialisation strategy is initially focused on the area of sexual health, the io® platform technology can be applied in a wide range of infectious disease and oncology diagnostic test areas.

John Clarkson, CEO of Atlas Genetics, said: “This is a major milestone for Atlas Genetics and marks the beginning of the next phase of growth for Atlas as we move to commercialise our first product and expand the io® infectious disease menu of tests. STIs are on the rise and the faster a diagnosis can be made, the faster treatment can be given, not only benefiting the patient but also saving time and money. We believe that our io® platform will play a key role in the future of STI diagnosis.”

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Expansion of US Office

Bath, UK, January 8, 2016. Atlas Genetics Ltd (“Atlas Genetics” or the “Company”), the ultra-rapid Point-Of-Care (POC) molecular diagnostics company, today announces the appointment of Bob Johnston as Chief Financial Officer, who will be based in the recently opened Boston office.

Bob has over 20 years of experience in the life science industry where he has a very successful track record in all aspects of growing companies.  His experience includes substantial equity and debt fund raisings, mergers/sales and acquisitions and taking companies public in the US.  His extensive CFO expertise includes the successful growth and acquisition of Ascension Orthopedics, Tutogen Medical and Oncormed and the successful acquisition of Scientific Protein Laboratories.  Bob will be located at the Boston office along with Keith Stauffer, VP Sales and Marketing, whose appointment was announced in November.

John Clarkson, CEO of Atlas Genetics, said:  “We are delighted to welcome Bob to Atlas Genetics.  With the CE mark for our first product expected shortly, Bob’s broad experience in the life sciences industry will be invaluable to Atlas Genetics as we enter our next phase of growth.”

Bob Johnston, CFO of Atlas Genetics, added: “With the anticipated launch of the Company's first product, 2016 will be an important year and I look forward to working with John and his team in growing Atlas Genetics into a major force in point of care molecular diagnostics.  I believe the Company has great potential in this field.”

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Atlas Genetics appoints Keith Stauffer as VP Sales & Marketing

Bath, UK, November 16th 2015. Atlas Genetics Ltd (“Atlas Genetics” or the “Company”), the ultra-rapid Point-Of-Care (POC) molecular diagnostics company, today announces the appointment of Keith Stauffer as VP Sales and Marketing. Based in the newly opened Boston office, Keith will lead the launch and commercialisation of the Atlas Genetics io® System.

Since 2011, Keith has been VP Marketing for Infectious Diseases at Alere Inc., where most recently he was responsible for developing the pricing strategy, aligning reimbursement initiatives and marketing campaigns for the launch of the Alere i ™ Flu test, the first CLIA waived POC molecular rapid flu test. In the first 12 months from launch over 2,500 instruments were placed. Previously, Keith was VP Sales for the Clinical Products Group within Alere, which included infectious disease POC tests. Prior to Alere, Keith worked for Thermo Electron in their Point of Care and Rapid Diagnostics division.

John Clarkson, CEO, said: “We are delighted to welcome Keith to Atlas Genetics. With CE mark approval for our first test anticipated around the end of this year we are about to enter the next phase in the growth of the Company. Keith’s expertise in the development and roll-out of commercialisation strategies within this field will be invaluable as we bring our ultra-rapid point of care tests for Sexually Transmitted Infections and Hospital Acquired Infections to market.”

Keith Stauffer, VP Sales & Marketing, added: “The io® System developed by Atlas Genetics offers a unique solution to the delivery of high quality testing results at the point of care. I believe that this system will transform the treatment and management of patients with infectious diseases across a range of clinical areas and I look forward to working with John and his team to launch the io® System in Europe and the US.”

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Simultaneous Detection of Infection and Antibiotic Resistance

Bath, UK, 11 June 2015. Atlas Genetics Ltd (“Atlas” or the “Company”), the ultra-rapid ‘test and treat’ molecular diagnostics company, today announces a collaboration with St George’s, University of London to develop and evaluate DNA-based point of care tests which can simultaneously detect both infection and antibiotic resistance in a patient within the same clinical visit.

The programme has been awarded £1.5 million by the National Institute for Health Research (NIHR) under its Invention for Innovation (i4i) programme.

Antibiotic resistance represents a huge challenge to current medical practices which rely on the use of antibiotics. Bacteria can become resistant to antibiotics in a number of ways through mutations or the addition of new genetic elements. Rising antibiotic resistance cannot only lead to patient treatment failure, but the uncertainty of an antibiotic’s efficacy can drive clinicians towards the routine use of increasingly more potent antibiotics for simple infections, often at an increased cost to the health service. This cycle escalates the risk of bacteria developing resistance to these antibiotics, potentially reducing their clinical utility in the future.

Researchers at St George’s Applied Diagnostic Research and Evaluation Unit have developed genetic assays which can identify the specific mutations that signpost resistance and therefore guide appropriate treatment. These assays are applicable to a wide range of bacteria, but the initial focus is on those bacteria where widespread resistance is becoming a major global concern. Atlas Genetics is integrating these assays on to the io® system to provide both bacterial identification and antibiotic resistance in a single 30 minute test. The project includes healthcare professional and patient input into the design of the test and will conclude with a 1,000 patient clinical study, coordinated by St George’s and is expected to be complete in 2017.

John Clarkson, CEO of Atlas Genetics, said: “Our cutting-edge diagnostic technology will enable patients to get their test results faster and guide clinicians to the best treatment option within a single appointment. This is an essential step in making sure antibiotics are used correctly every time and we are excited to be part of the solution to antibiotic resistance in the UK and globally.”

Dr Tariq Sadiq, Chief Investigator at St George’s, commented: “This process of diagnosis has already been shown to be very reliable and so we are confident that we will be able to identify which drugs to use to successfully treat the infection. Within one short visit, patients will get their diagnosis and a bespoke treatment. We believe that this test-and-treat method will reinforce clinicians’ confidence in the antibiotics they choose for their patients.”

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First application of the Atlas io system outside of infectious diseases

Bath, UK, 15 April, 2015. Atlas Genetics Ltd (“Atlas Genetics” or the “Company”), the ultra-rapid ‘test and treat’ molecular diagnostics company, today announces that it has entered into a collaboration with a major pharmaceutical company to develop a diagnostic test, expanding capabilities beyond infectious diseases.

The io® system is a highly novel molecular diagnostic system developed initially for the ultra-rapid diagnosis of a broad range of infectious diseases. It is based on a patent-protected electrochemical sensor technology that combines speed, accuracy and low manufacturing costs.

The fully integrated cartridge contains all reagents on board and is designed to receive an unprocessed clinical specimen. The cartridge is then inserted into the reader instrument which then completes the three-stage process of sample preparation, DNA amplification and electrochemical detection. Each cartridge can carry out up to 24 different tests from a single patient sample. This new companion diagnostic collaboration is the first outside of infectious disease.

Dr John Clarkson, Chief Executive Officer of Atlas Genetics, commented: “We are delighted to be exploring this exciting new use of the io® system. Our superior multiplexing capability allows for significant future menu expansion across a range of disease indications. This new collaboration clearly demonstrates this flexibility and the wide ranging applicability of the Atlas Genetics io® system.”

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