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.”

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.”