Establishes manufacturing capability at Bespak UK
Atlas Genetics, a UK developer of ultra-rapid diagnostics to enable a ‘test and treat’ solution for infectious diseases located near Bath, Avon, has completed the installation and commissioning of its manufacturing line for the Atlas io cartridge at Bespak. The io cartridge was developed in collaboration with drug delivery devices supplier Bespak for use with the Atlas io reader, and together they form a point of care system that can deliver laboratory quality results for molecular assays in under 30 minutes.
The io system offers fast diagnosis of a broad range of infectious diseases including sexually transmitted infections (STIs) and hospital acquired infections. It is based on a patented 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. It is then inserted into the reader which 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 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 purpose-built ISO Class 8 cleanroom at Bespak’s site in King’s Lynn, Norfolk, 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 products for validation activities and clinical studies later this year to support the subsequent application for regulatory approval in Europe early next year.
The cartridge will initially be available for the diagnosis of chlamydia, but a pipeline of other tests and combinations is already under development. The platform has the potential to test for up to 24 different diseases on a single cartridge.
‘Manufacturing capability is an important step on the road to regulatory clearance and a significant milestone in the commercial development of our io platform,’ said John Clarkson, CEO of Atlas.
‘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, added: ‘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.’