News‎ > ‎Full Stories‎ > ‎

13 October 2017

posted Oct 13, 2017, 12:23 AM by Beck Lockwood   [ updated Oct 16, 2017, 1:30 AM ]
New partnership will bring specialist blood tests into clinical laboratories

An instrument that can enable complex blood tests to be carried out in clinical laboratories could soon be commercially available, thanks to a new partnership between NIHR DEC Leeds and clinical diagnostics company, Thermo Fisher Scientific.

Called the Thermo Scientific™ Cascadion™ SM Clinical Analyzer*, the instrument analyses samples using mass spectrometry and liquid chromatography – techniques which usually need to be carried out by specialist laboratories. Because the Cascadion Analyzer offers a fully automated process, the test can be carried out by any laboratory technician.

The Cascadion Analyzer will enable clinicians to analyse the levels of immunosuppressant drugs in the blood of patients who are receiving treatment as a result of organ transplantation. These drug levels need to be carefully monitored, as high doses can cause severe side effects, whereas if the dose is too low, there is a risk of organ rejection.

NIHR DEC Leeds is working with Thermo Fisher Scientific to facilitate access to surplus blood samples at Leeds Teaching Hospitals NHS Trust. The Trust is supplying 300 whole blood samples from liver and heart transplant patients taking the immunosuppressant drugs cyclosporine and tacrolimus.

The samples, which would otherwise be thrown away, are completely anonymous, and will be used by Thermo Fisher Scientific to validate the performance of the assay, to ensure it is safe and accurate for use in the NHS and other healthcare systems. With the gathered evidence, the company plans regulatory submissions which will enable it to make the system available for patient benefit.

Dr Rosie Ferguson, Programme Manager at NIHR DEC Leeds, says: “Getting access to samples can be logistically difficult for companies as the correct protocols have to be followed, as well as the practical issues of appropriate transport and storage.”

“NIHR DEC Leeds’s mission is to build relationships between the NHS, academia and industry, and to find ways to bring new products that will benefit patients to market quickly and efficiently, so we were ideally placed to find ways to address these challenges.”

Sarah Robinson, Market Development Specialist at Thermo Fisher Scientific, adds: “NIHR DEC Leeds have been fundamental in ensuring that Thermo Fisher Scientific is able to access these samples. Without these, we simply would not be able to provide the evidence required for the Cascadion Analyzer to meet the very stringent regulatory requirements in Europe and in the US.”

The Cascadion Analyzer is focusing on analysis of immunosuppressant drugs and other assays, including testing levels of Vitamin D and testosterone – both commonly requested tests which are currently difficult to analyse accurately.

*This product is still in development and not yet available for sale.