About Bio

Customer Focus

Established in 1979, Bio-Diagnostics is privately owned, rapidly growing, UK bio-tech business, based 40 miles south west of Birmingham, UK.

Bio-Diagnostics is highly regarded and trusted globally, working closely with partners providing, Distribution, Medical Logistics, Contract Manufacture, (including final kit assembly and cartoning), Contract R&D, Laboratory Services, sample processing and testing.

Operating from a complete UK registered facility, providing a fully regulated address for certification requirements post Brexit to third parties.

• Distribution – A Distributor of Medical products for third parties
• Medical Logistics – Provider of Medical Logistics to third parties for global despatch and transportation of their products
• Manufacture – GMP certified for own and contract manufactured healthcare products, IVDs, and associated medical products
• Laboratory Services and testing. – Provider of clinical laboratory services to third parties who require use of a fully certified and regulated facility for the testing of patient samples. ISO30485 accredited laboratory.
• UK registered fully regulated address for certification requirements post Brexit to third parties.

As the longest established Autoimmune company in the UK, our expertise in immunology has enabled rapid establishment as the clear market leader in many aspects of Allergy testing as well as treatments in the UK.

Bio-Diagnostics now has 4 main divisions in Immunology, Immunohistochemistry and Dermatology, and Allergy and continues to work with commercial and academic entities on projects to take a concept through to commercial products.

As Market leaders in Allergy we can provide:

• Laboratory services – providing access to Consultants and Allergy Specialists who require the quality standards of professional laboratory results, identical to those used in leading global hospitals and centres of excellence.
• Testing service access for B2B, private hospital and similar contracted testing.
• Access to a regulated facility for businesses requiring a private Laboratory to process send in samples from their home testing packs.

New product development 2020

The QuickCard™ is a uniquely adaptable testing platform, that provides the equivalent of a lab in a credit card sized device for a wide variety of applications.

With the emergence of Cov19, Bio-Diagnostics in February 2020, began work on utilising its knowledge of this unique proprietary diagnostic platform and with a culmination of new adaptations developed the patented BioCard™. This unique device has been developed to eliminate a number of shortcomings inherent to the original QuickCard platform and design.

With an established supply chain predominantly sourced from within the UK, the BioCard™ is created entirely from raw materials within Bio-Diagnostics facility. This novel IVD which introduces structural innovations in combination with adaptable biochemistries for more accurate and reliable results forms a robust device and minimises risks of biohazardous contamination after use.

Virtually every disease has the potential to be tested for, utilising the BioCard™ technology, with results in minutes, anywhere, without need for power, closed system instruments or additional equipment. With established methods to test either sera or whole blood, sampling is possible utilising home test packs, containing only a lancet and small vial, then returned in the appropriate postal envelopes. The device has the potential to be used anywhere in the world, where a viable antibody/antigen or similar binding process occurs.

Processing of the test can be completed quickly in any setting, from a professional laboratory to a pop-up mobile clinic or drive through. Home testing is viable with finger prick blood use, or simply return of small blood sample to a testing site.

Reporting can be completed via any traditional channel, including digital means if required.

International Development Opportunities

Bio-Diagnostics has already developed via contract R&D, diagnostic solutions for specific target interactions and those products are now commercialised for global sales generating millions of dollars. Bio-Diagnostics continues to work with third parties who wish to access the technology and embark on new applications for their own goals. Bio-Diagnostics makes this potential available and a reality.

For wider international markets in the USA, Asia, Middle East, and Europe the company is focused on a B2B development path, looking for technically competent and established partners to represent applications of Bio-diagnostics products and technologies, or provide access via licensing and other arrangements.

Contract Manufacture and Global Clients

Redevelopment of the facility began in 2019, its facility is being custom built to carry out projects through from its inception to delivery. Bio-Diagnostics manufactures and processes products for well-known brands who rely upon it to consistently maintain their exacting standards without exception.

Bio-Diagnostics continually reinvests into future business growth by actively engaging with a process of continual improvement of its core technology platforms and the processes to manufacture them.

The Bio-Diagnostics facility is a complete “start to finish” operational complex. From Research and Development to the commercial receipt of a sales order, all aspects are handled on one site, efficiently and quickly.

With Offices, task-specific laboratories, logistics resources and a fully adaptable manufacturing facility, Bio-Diagnostics has proven itself an adaptable corporation which is expanding rapidly into new areas of interest.

At its core as a technical specialist in the field of Immunology, is a highly competent technical team, who can adapt to the ever-changing landscape and challenges demanded of them.

Bio-Diagnostics has consistently committed itself to provide reliable support to our customers.

Beyond the Quality Standard

Bio-Diagnostics is accredited with all relevant industry standards it requires to operate successfully in the Medical sector. It is certified to the ISO13485 Quality Management System and holds a Wholesale Distribution Authority from the MHRA, for diagnostic platforms and technologies, both for itself and in the private label under contract manufacture arrangements, readily adaptable
To best serve its global customer base, Bio-Diagnostics selects only high quality technically proven products, backed by proven scientific research and published papers.

The company holds a Wholesale Distribution Authorisation, issued by the MHRA, which enables us to import and distribute specialist products such as patch test allergens, skin prick test allergens and allergy vaccines. As one of the only UK companies still operating a private immunology laboratory in our field, the company participates in UK NEQAS and maintains membership of organisations such as the IBMS, BIVDA and the UK Chamber of Commerce. Our Laboratory is critical to the continual improvement of our technologies and serves to ensure we are prepared for whatever potential demands we may face.

Our own highly efficient and flexible operation within our UK manufacturing plant is able to fulfil large or small orders and can assist SMEs with regulatory affairs for contract development and manufacture if required. Packaging and laboratory facilities are available for both original equipment manufacturer (OEM) and proprietary products.

Training and Support

As a result of our Technical base, our service goes beyond delivery. If required by absence, loss of resources, or unexpected change, all our products are complemented by seminars, workshops, and a high level of technical expertise wherever we can be of service. We are also able to offer training and workshops at our laboratory in Worcestershire, or at your own site. In an industry increasingly dominated by huge global entities, we remain committed to offering a superior level of friendly customer service and maintain high quality as standard. If you suffer the loss of your refrigerated stocks, whether you are an existing customer or not, we will work with you to support rapid replacements to enable you to maintain patient appointments and your services. To this end, we hold significant stocks of Allergens and many of the wider products from our ranges.