Transgenomic and Power3 Medical Products have announced the advance online publication of a clinical research paper in the Biochemical and Biophysical Research Communications scientific journal.
The study, entitled 'Abnormal Serum Concentrations of Proteins in Parkinson's Disease', demonstrates the usefulness of a protein biomarker panel to distinguish Parkinson's Disease (PD) patients from age-matched normal controls, independent of the severity of symptoms, using clinical blood serum samples.
The analytic technology forms the basis for the NuroproPD test for PD being commercialised by Transgenomic as per a licensing/collaboration agreement with Power3 Medical signed in early 2009.
The publication of the peer-reviewed article is described as a validation milestone in the clinical development of the NuroproPD diagnostic assay.
The article describes the use of analytically validated quantitative 2D gel electrophoresis to identify protein biomarkers for diagnosing PD using serum from routinely collected blood samples.
Some 57 protein biomarkers, which had been discovered using retrospective blood serum samples from various neurodegenerative diseases, were then applied specifically to PD in a prospective clinical investigation using freshly collected blood serum from PD patients and age-matched normal controls.
A multi-variate statistical method, stepwise linear discriminant analysis, selected a combination of 21 of the biomarkers as optimal to distinguish PD patients from controls.
When applied to the PD samples, the 21-protein set had sensitivity of 93.3 per cent (52 of 56 PD correctly classified) and specificity of 92.9 per cent (28 of 30 controls correctly classified); 15 of 15 patients with mild and 28 of 30 with moderate-to-severe symptoms were correctly classified, as were all six PD samples from an independent site.
Craig Tuttle, chief executive officer of Transgenomic, said: 'We are enthusiastic about the acceptance of our paper in this established peer-reviewed scientific journal.
'It represents independent external validation of the clinical data and so increases the confidence that we have in NuroproPD to be a meaningful tool for the diagnosis of Parkinson's Disease, especially early in its course.
'We are completing the clinical validation of the assay in our CLIA-certified molecular testing laboratory and will be launching the assay in the very near future,' he added.
Dr Ira Goldknopf, president and chief scientific officer of Power3 Medical and lead author on the paper, said: 'In the US, there are an estimated 1.5 million individuals with Parkinson's Disease.
'Unfortunately, by the time patients are given a probable diagnosis, many have already suffered substantial and irreparable brain damage, rendering treatment less effective.
'The fact that these results were obtained using fresh blood serum, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for their robustness and their commercial value.' Clinical investigators in the study were Dr Katerina Markopoulou of Thessaly University in Greece, Dr Marwan Sabbagh and Dr Holly Shill of Banner Sun Health Research Institute in Sun City, Arizona, and Dr Stanley Appel of the Texas Methodist Health System in Houston.
