Transgenomic, Inc. (OTC Bulletin Board: TBIO) and Power3 Medical Products, Inc. (OTC Bulletin Board: PWRM) today announced the advance on-line publication of a clinical research paper entitled "Abnormal Serum Concentrations of Proteins in Parkinson's Disease" in the scientific journal Biochemical and Biophysical Research Communications. The study 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 NuroPro(R)PD test for PD being commercialized by Transgenomic as per a licensing/collaboration agreement with Power3 Medical signed in early 2009. The publication of the peer-reviewed article is a significant validation milestone in the ongoing 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. 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% (52 of 56 PD correctly classified) and specificity of 92.9% (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 6 PD samples from an independent site.
"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," said Craig Tuttle, CEO of Transgenomic. "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."
"In the U.S., 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," said Dr. Ira Goldknopf, President and CSO of Power3 Medical and lead author on the paper. "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 the University of Thessaly, Greece, Drs. Marwan Sabbagh and Holly Shill of Banner Sun Health Research Institute, Sun City, Arizona, and Dr. Stanley Appel of the Texas Methodist Health System, Houston.