BATH, England, June 17, 2014 /PRNewswire/ --
Atlas Genetics Ltd (“Atlas” or the “Company”), developer of innovative, ultra-rapid diagnostics to enable a ‘test and treat’ solution to infectious diseases, today announces that the installation and commissioning of its manufacturing line for the Atlas io® Cartridge at Bespak has completed. The io Cartridge was developed in collaboration with Bespak for use with the Atlas io Reader, which together form a Point of Care system that can deliver laboratory quality results for molecular assays in under thirty minutes.
The io system is a highly novel molecular diagnostic system for the ultra-rapid diagnosis of a broad range of infectious diseases including Sexually Transmitted Infections (STIs) and Hospital Acquired Infections (HAIs). 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 which then completes the three-stage process of sample preparation, DNA amplification and electrochemical detection, to analyse the patient’s sample for the target infection.
In addition to deployment in hospital settings, the io system will make it possible, for the first time, to carry out a broad range of infectious disease tests in primary care clinics and GP surgeries that are as accurate as those carried out in hospital laboratories. This will enable clinicians to test and commence treatment within the same appointment and ensure much improved compliance, particularly in the area of STIs, where a significant proportion of patients fail to return for test results or follow-on treatment.
The manufacturing line for the io Cartridge has been established within a dedicated purpose-built ISO Class 8 cleanroom at Bespak’s site in Kings Lynn, UK. The line will use components and reagents from a supply chain of qualified suppliers which has also been established.
The io Cartridge is now entering pilot manufacture to supply Cartridges for validation activities and clinical studies later this year to support the subsequent application for regulatory clearance in Europe early next year. The io Cartridge will initially be available for the diagnosis of Chlamydia, but a pipeline of other tests and combinations are already under development. The platform has the potential to simultaneously test for up to 24 different diseases on a single Cartridge.
John Clarkson, CEO of Atlas, said: “Manufacturing capability is an important step on the road to regulatory clearance and a significant milestone in the commercial development of our io platform. The establishment of manufacturing at Bespak further differentiates Atlas from other diagnostic companies and will facilitate the future scale-up in capacity for our products.”
Keyvan Djamarani, MD of Bespak, commented, “We are very pleased to have completed the industrialisation of the Atlas io Cartridge and to have the manufacturing line operational in King’s Lynn for pilot manufacture, in support of clinical testing for CE mark approval. We are excited by the product and the commercial opportunity which it presents in the Point of Care Testing space.”
About Atlas
Atlas (Atlas Genetics Ltd) develops ultra-rapid decentralized and point-of-care (POC) diagnostic tests for infectious diseases. The Atlas io® system uses patented technology based on the use of a novel electrochemical sensor that combines speed, accuracy and multiplex detection capability. The Company has its head office and laboratory facilities near Bath, UK. Atlas was established in 2005 and is financed by VC, corporate and private investors including Novartis Venture Funds, Consort Medical plc, J&J Development Corporation, Life Science Partners (LSP), BB Biotech Ventures and YFM Equity Partners.
Rapid and simple-to-use diagnostics offer health professionals the ability to test for medical conditions at or close to the site of patient care. Atlas has developed a flexible technology platform for decentralized and POC testing, which has been designed to accurately and quickly diagnose a wide range of medical conditions within 30 minutes. The Atlas io system consists of an inexpensive Reader into which a disposable Cartridge containing a patient sample is inserted. The system is scheduled for clinical trials later this year, followed by rollout in Europe and the United States, pending regulatory approvals.
Atlas is developing tests for a range of infectious diseases including sexually transmitted infections and hospital acquired infections. The Atlas io system will initially be launched for the testing of Chlamydia and Gonorrhoea, allowing clinicians to test and treat patients in a single visit. Over 50 million tests are carried out for these diseases in Europe and the US every year. According to the European Centre for Disease Prevention and Control, Chlamydia is the most frequently reported Sexually Transmitted Infection, with prevalence rates in young people between 5-10%, whilst Gonorrhoea is the second most commonly reported STI. The worldwide in vitro diagnostic market for infectious disease testing is estimated to be worth around £8 billion.
For more information on Atlas see http://www.atlasgenetics.com
About Bespak
Bespak, a Consort Medical company, is a leading global supplier of drug delivery devices for injectable and inhaled products.
Bespak has contributed to the design, development and industrialisation of some of the world’s leading medical devices. Headquartered in the UK and with representation in a number of key territories, Bespak employs over 600 people and manufactures more than 500 million medical devices each year, supporting device programmes from pilot-scale to commercial supply. Bespak has long-established partnerships with leading pharmaceutical and biotech industry clients, with several products successfully launched and marketed worldwide.
Bespak provides the capability and expertise to reduce time to market, allowing customers’ products to be developed, tested and manufactured faster and with minimised risk. With an in-depth understanding of Design For Manufacture and a robust Continuous Improvement methodology, Bespak’s Programme Management capability supports the full lifecycle of a product.
For more information on Bespak see http://www.bespak.com
For more information on Consort Medical see http://www.consortmedical.com
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