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.”

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.”