Innovation in Immunology
Central to the company’s growth has been novel 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 necessarily requiring any instrumentation, power, or a laboratory 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 a serum, to a field location using whole blood.
For Cov19, QuickCard™ has been redeveloped with both physical and biochemical adaptations to become the BioCard ™, a patented IVD which remains unique in the market in achieving the speed and sensitivity for this kind of laboratory diagnostic. These credit-card sized tests can be completed within 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 and is the recommended confirmatory test by the CDC for this serious STD, due to its outstanding accuracy.
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 contract manufacturing capabilities across a diverse number of technologies and specialist fields.
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. More recently, the company was the first to have commercially launched a set of controls specifically developed for use with automated platforms, where an independent validation sample is mandated.
Following the discovery of Cov19, Bio-Diagnostics have diverted all R&D capacity towards solutions towards testing phases of the disease, with a number of devices completed, and further concepts in development.
The improvements brought by the BioCard™ will further enhance the accuracy and speed of testing long after Cov19 has been resolved. At that time, areas of development for the technology will reach far beyond the existing boundaries, with principal focus being in Viral and Infectious Disease, Parasitological applications, food manufacturing in line testing, global crop testing to prevent famine, as well as private label bespoke diagnostics. Crucially, access to the BioCard™ platform will be a specific 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
At the heart of the Companies philosophy to that testing is a critical, and essential, first step in identifying any disease, and then enabling healthcare professions a knowledge upon which to act with greater confidence. Diagnosis is a powerful tool in epidemiological studies, front line testing, as well as providing essential data for those confirming results from vaccination developments globally.
For the Future
Where the BioCard™ technology is to be supplied to non-profit research entities who wish to consider the BioCard as a platform, licence opportunities can be considered with the potential to put aside commercial profits, with the hope that this will drive down testing costs and enable diagnosis of diseases 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, whilst actively diversifying its interests. 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.