Innovation

Innovation in Immunology

Central to Bio-Diagnostics’ expansion beyond its original focus is a stream of novel medical-diagnostic innovations. The R&D team’s QuickCard™ was the first to bring niche, point-of-care (POC) testing to autoimmune disorders such as GBM, MPO and PR3.

For Covid-19, we understood that existing approaches had to be re-engineered, physically and biochemically, to become faster, more accurate and reproducible. Most importantly, the next alternative to lateral-flow devices had to be quantitative.

The birth of BioCard™

The result is BioCard™, a globally patented IVD that uniquely delivers both the speed and sensitivity demanded of laboratory or field diagnostics. It reduces a conventional four-hour, instrument-based workflow to as little as three minutes per test, without the need for instrumentation, power or a laboratory.
“Results on a par with, or better than, ELISA and CLIA systems.” — UK HPA
By combining all the benefits of laboratory processors with the accessibility of lateral-flow tests, BioCard™ introduced a no-compromise route from diagnosis to treatment in a single visit.

27 separate steps to treatment, and their costly delays, become one appointment
No blood transport is required
Clinical decisions can be made at first contact

Ultra-rapid, universally deployable

This credit-card-sized system can be adapted to virtually any disease or analyte. Used with serum in the laboratory or whole blood in the field, BioCard™ delivers results within minutes and requires no reader.

A companion smartphone app can geo-locate pandemic disease or immunity spread in real time, helping the world stay one step ahead of “Disease-X”.

Proven gold-standard performance

In its finger-prick format, the Genital Herpes (HSV-2) BioCard holds FDA 510(k) clearance and is recognised in the USA as equivalent in sensitivity to traditional gold standards like Western blot. It is the only FDA approved test specifically recommended by the CDC for this endemic STi, thanks to outstanding accuracy demonstrated in multiple independent studies.

Host-response testing is the future of clinical diagnosis, BioCard™ already delivers it.

A legacy of quality and expertise

From the original IFA programme, Bio-Diagnostics became one of the first to introduce ELISA tests for vasculitis. Our fully regulated (FDA and ISO 13485), manufacturing facilities now provide wide-ranging contract capabilities across multiple technologies. We were also the first to launch positive controls tailored for automated platforms, where independent validation samples are mandatory.

Autoimmunity remains a core specialism—some diseases demand urgent diagnosis, others require differentiation of several auto-antibody components. Bio-Diagnostics was the first to offer a complete autoimmune diagnostic range to UK immunology laboratories and continues to set the benchmark for consistent quality and technical support.

New horizons

Since the emergence of Covid-19, we have channelled all R&D into solutions for each phase of the disease and beyond. BioCard™’s advantages will persist long after Covid-19 is resolved, with development focused on:

Human and vetanary viral & Infectious Diseases
Allergy and intolerance
Food-manufacturing in-line testing
Global crop diagnostics to increase crop yield and prevent famine
Private-label bespoke tests, contract R&D and manufacturing

Crucially, the BioCard™ platform enables ultra-rapid POC diagnosis for socio-economic diseases that burden developing nations where healthcare access is limited.

Diagnosis: where treatment begins

Our philosophy is simple: testing is the essential first step in combating any disease. Fast, reliable diagnosis empowers healthcare professionals to act with greater confidence, supports epidemiological studies, and provides vital data for vaccine-development programmes worldwide.

For non-profit research entities, we are ready to license BioCard™ on non-commercial terms that prioritise affordability, driving down testing costs where economic barriers once prevented diagnosis, and therefore treatment. If you are associated with the Bill & Melinda Gates Foundation, UNICEF, World Health Organization (WHO), FIND – Foundation for Innovative New Diagnostics, Unitaid, Clinton Health Access Initiative (CHAI), PATH, The Global Fund to Fight AIDS, Tuberculosis and Malaria, Médecins Sans Frontières (MSF) or alike we’d love to help you achieve your objectives making accurate accessible testing affordable anywhere.

Consistent quality

Renowned for reliability and outstanding technical service, Bio-Diagnostics remains committed to its foundational specialisms while actively diversifying. Delivering the highest possible quality continues to propel the company and our partners forward.