Nottingham University Hospitals ‐ Delivering exceptional service for external clinical evaluations
The external evaluation of any diagnostic kit is the cornerstone for the commercial release of any product in the medical industry. R&D activities are focused on achieving product design requirements, where rigorous testing protocols and procedures are set in place to ensure that the product performs to the highest technical standards. In addition to the extensive testing and validation carried out internally, diagnostic companies seek partners in a clinical setting to support the generation of additional data demonstrating that the product meets the stringent quality requirements in a real world setting.
A reputable institution with a good track record for clinical excellence
During the development of our new dual staining detection kit, Leica Microsystems were looking for a reputable institution with a good track record for clinical excellence to evaluate our new dual chromogen detection system – ChromoPlexTM 1 Dual Detection for BOND. Leica was looking for a laboratory that routinely performed dual staining using antibody cocktails. Nottingham University Hospitals (NUH) met all our requirements.
Sourcing and providing ethically approved tissue to provide clinically relevant information is a service provided by the Nottingham Health Science Biobank
Since the implementation of the Human Tissue Act of 2004, it has become more difficult to conduct clinical trials due to the shortage of ethically approved tissue. In some cases acquiring clinically relevant and ethically approved tissue can take months and can significantly delay the full commercialization of new products.
Leica approached the Nottingham Health Science Biobank (NHSBB) at Nottingham University Hospitals Trust for the evaluation of ChromoPlex 1 Dual Detection for BOND. Testing was to be carried out on a statistically relevant number of samples to validate the performance of our new dual chromogen Detection kit. Within days NHSBB were able to source & screen cases to ensure that we had the statistically relevant number of tissue samples required to perform the external appraisal of ChromoPlex 1 Dual detection for BOND.
Delivering the highest quality of stained slides
Good laboratory practice and competent, skilled staff are a prerequisite for producing good quality slides for clinical assessment. The slides we received from NUH met the highest quality standards in terms of tissue processing, microtomy and advanced staining using the BOND platform.
Flawless execution of the clinical trial protocol
Rigorous and detailed data collection and assessment and a robust audit trail are essential to meet Leica’s, as well as various international regulatory bodies’ requirements to ensure that quality standards are maintained. The flawless execution of the trial protocol by NUH provided to Leica an independent assessment of the clinical performance of ChromoPlex 1 Dual Detection for BOND in a routine laboratory.
When time is of the essence, Nottingham Health Science Biobank (NHSBB) at Nottingham University Hospitals Trust deliver quality results you can depend on Protracted clinical evaluations can result in significant delays in the launch of new products. The rapid progress in disease state management demands that commercial companies are quick to respond to making new technologies available to laboratories to enable them to significantly impact on the patient care pathway. NHSBB and NUH completed the clinical trial ahead of the strict and challenging timeline agreed to by Leica and the Trust. Consequently, we could commercialise ChromoPlex 1 Dual Detection for BOND within our timelines.
Leica would recommend the Nottingham Health Science Biobank at Nottingham University Hospitals Trust to any company requiring a world class clinical evaluation. We were able to launch ChromoPlex 1 Dual Detection for BOND with confidence that the kit had been extensively validated in our laboratories, and that the performance in a routine laboratory had been validated by a reputable independent laboratory.
David Budd, Director of Commercial Development and Product Management, Leica Microsystems
