BioSure UK Ltd
BioSure (UK) Ltd develop, manufacture, source and distribute rapid tests with the highest levels of accuracy, many rivalling those of standard laboratory tests. Our rapid diagnostic and detection tests are invaluable tools where immediate results are the primary consideration. The tests that we manufacture and supply are used worldwide for the management of human infectious disease.
BioSure (UK) Ltd specialise in providing solutions utilising rapid Point of Care Tests (POCT) and has unique expertise in self testing. We passionately believe that this technology through integration into healthcare settings and for use as self tests can revolutionise testing protocols, reduce late diagnoses, provide cost effective testing solutions for the general population and engage hard to reach key populations. Ultimately budgets can be spread further through far lower delivery costs and immediate diagnosis.
Cost effective, straightforward, fast and accurate – it is our aim to bring self-testing for disease to the mainstream.
The Team Behind the HIV Self Test
BioSure (UK) Ltd are the manufacturers of the first CE marked HIV Self Test for personal use. Since launching our BioSURE HIV Self Test in 2015 our products have helped people throughout the UK and the world, to #knowyourstatus.We develop, manufacture and distribute world class point of care rapid tests. We also developed and launched the world’s first approved HIV self test to use blood (round of applause please!)
Accredited and Clinically Recognised
BioSure(UK) Ltd is registered with the Medicines and Healthcare Agency (MHRA) and accredited with the European Medicines Agency (EMA) and UKAS. BioSure has ISO 13485 & MDSAP certification. These are the internationally recognised standards for quality management systems for the manufacture of medical devices. It specifies the requirements for the robust quality management system that an organisation needs to manufacture and provide a medical device that consistently meets customer needs and regulatory requirements.
The BioSURE HIV Self Test is a CE Marked product. This means that our products are independently tested and verified by a Notified Body. The BioSURE HIV Self Test is independently verified by the BSI Group (notified body number 2797). BioSure’s regulatory compliance is managed by Gary Carpenter, Clinical and Regulatory Affairs Officer.
Internationally, the BioSURE HIV Self Test has been recognised in studies by world leading HIV health organisations such as PATH and WITS University. In the UK, our products have been through multiple clinical evaluations to validate our users have a simple to use test that gives them an accurate reading when testing themselves. Our test has been used in clinical studies looking at the impact of accessible HIV testing by the NHS, University College London, the Terrence Higgins Trust, UKCAB, Sussex University, plus many others.
Award Winning Team
BioSure (UK has been recognised for it’s work in numerous awards:
- Winner in the national Barclays’ Entrepreneur Awards 2020, recognising entrepreneurs who are transforming their industries, the economy, and society.
- Our CEO Brigette Bard won a @Cofinitive #21ToWatch award, recognising innovation and entrepreneurship across the globe.
- BioSure made Start Up Of The Day on the Innovation Origins independent news platform in Europe for contributing to the world of innovation.
- Brigette Bard made the Maserati 100 Index 2019 – celebrating entrepreneurial excellence in the UK.
- 2018 Winners of Pitch@Palace 10.0