Overview
The North East Innovation Lab is part of Newcastle Hospitals and works with organisations of all sizes, from university spin outs to large international companies, to support the development of diagnostic tests by providing access to clinical samples and independent performance evaluations. We have an HTA-registered biobank containing over 20,000 SAR-Cov-2 samples, access to other biobanks and diagnostic labs within the Trust, as well as our own research nurses which enable us to prospectively collect bespoke samples for this and other diseases on request.
We can support with diagnostic test evaluations, including proof of concept, analytical performance, and clinical performance evaluations. We can also help develop study protocols and provide control materials. The evidence we provide is often used in CE and UKCA marking of IVDs, as well as submissions to the CTDA and FDA, and to satisfy compliance with IVDR.
Services we offer
- Diagnostic Test Evaluations including Analytical & Clinical
- HTA Registered Biobank
- Prospective Collection of Samples
- Methodical Support and Study Design
- Laboratory Services