Innovation in Immunology
Central to the company’s growth have been innovations in the area of medical diagnostics using the QuickCard platform. The QuickCard is a unique innovation by Bio-Diagnostics R&D department, solving the key challenge of reducing a traditional process taking three hours using laboratory-based instruments, down to five minutes without any instrumentation at all. This ultra-rapid test system can be developed for virtually any disease or analyte, and as a point of care (POC) device could be used in virtually any environment in the world, from a laboratory with using serum, to a field location using whole blood.
Today the patented QuickCard is still unique in the market in achieving the speed and sensitivity for this kind of laboratory diagnostic. These credit-card sized tests can be completed in minutes, require no instrumentation and are the only available rapid tests for the detection of autoimmune disease. In its finger-prick of blood format, the (Genital Herpes) test has FDA 510K approval and has been clinically established in the USA as equivalent to western blot sensitivity for this serious STD.
Following the IFA programme, Bio-Diagnostics was one of the originators of ELISA tests for specific areas, particularly vasculitis. Bio-Diagnostics has full regulatory approved manufacturing facilities and offers a wide range of autoimmune ELISAS.
Autoimmunity encompasses a large spectrum of diseases, some of which require urgent diagnosis, others the differentiation of several autoantibody components. Bio-Diagnostics recognised the potential of this market and was the first company to market a complete range of diagnostic tests to UK immunology laboratories.
In 2011 Bio-Diagnostics were pleased to sign authorization to the Scimedx Corporation for a Global Licence which enables them to also manufacture and develop existing and new applications for the QuickCard POC technology. Scimedx have been involved in the Manufacture of Diagnostic Devices for over 30 years, and have a wealth of experience, as well as outstanding competencies in Research and Development.
As a result of this exciting new collaboration, a second FDA approved manufacturing site for the QuickCard platform now exists, set up with the direct assistance of Bio-Diagnostics and continued support of our technical staff on a long term basis, greatly increasing the capacity and efficiency for supplying both traditional, as well as developing world markets, with a much broader range of applications for this well established Point of Care technology. A 10 year program of Research and Development is now underway, which will broaden the scope and accessibility of this unique technology.
US customers can now maintain supply locally, with a new global network of distributors now able to access the technology across the globe in around 90 new territories. Areas of development for the technology will reach far beyond the existing boundaries, with principal focus being in Viral and Infectious Disease, Parasitological applications, private label bespoke diagnostics, as well as targeted disease ultra rapid POC diagnosis for combating socioeconomic diseases afflicting the Developing Countries of the world, where access to healthcare is limited or absent.
Diagnosis, where treatment begins
QuickCards were originally invented and developed by the late Philip Mico with a view to enabling the testing of diseases where healthcare and laboratory access was limited, as commonly occurs in the poorest parts of the world. Achieving the goal of supplying the QuickCard technology for this purpose has proved economically challenging if not impossible. However, as a part of the agreement between the companies, Simon, Philips son, has attempted to make this goal come a step closer.
For the Future
Where the QuickCard technology is to be supplied to an authorised charity or similar organisation, the agreement creates the potential to put aside commercial profits, with the hope that this will drive down testing costs, and enable diagnosis of disease in countries where economic factors would traditionally have prevented diagnosis, and therefore treatment.
Renowned for consistent quality and attention to outstanding technical service, today Bio-Diagnostics remains focused on its original specialisms. Providing the highest quality possible ensures the best value is offered to their customers, and it is this that continues to drive the company forward.
The latest choice of automation packages complements Bio-Diagnostics’ range of assays. Our extensive experience of IFA automation means our service engineers are able to set up, service and repair automation platforms supplied either by Bio-Diagnostics or third parties, where customers have previously made an outright purchase of a machine.
Bio-Diagnostics continues to grow its interests in specialised niche medical markets, particularly autoimmunity and dermatology, but with additional expertise in infectious disease and specialist Immunohistochemistry products. We are continuing to build on the strong growth in our traditional markets over the last few years, and are broadening our ranges further to fulfil our current and future customers’ needs.