Transgenomic Inc and Power3 Medical Products Inc, have announced the clinical introduction of the NuroPro® AD and NuroPro® PD tests for Alzheimer’s and Parkinson’s disease at the 2009 American Academy of Neurology meeting in Seattle.
The NuroPro tests help clinicians distinguish patients with Alzheimer’s and Parkinson’s diseases from "normal" individuals and patients with other neurological disorders.
The tests, developed by Power3, are a panel of blood serum protein biomarkers evaluated by biostatistical analysis to predict the probability a patient has neurodegenerative disease. This information will help physicians make earlier diagnoses and recommend appropriate follow-up and treatment options for their patients.
Katerina Marcopoulou, MD, Assistant Professor of Neurology at the University of Thessaly, Greece, gave a platform presentation of Phase I results of a prospective Parkinson’s disease trial of NuroPro PD at the AAN meeting. Her presentation covered data developed as part of the clinical validation of NuroPro PD being conducted at the University of Thessaly.
The results demonstrated that NuroPro PD was able to discriminate between Parkinson’s disease patients and age-matched control subjects with a sensitivity of 93% and specificity of 96%. In addition, samples from North American Parkinson’s disease patients were correctly identified with 100% sensitivity when tested against the Greek patient database. Dr. Marcopoulou also presented data correlating blood serum concentrations of some of the key protein biomarkers utilized in the NuroPro PD assay with the severity of Parkinson’s disease as measured by two separate clinical scoring methods.
Through a collaboration/licensing agreement between Transgenomic, which develops and provides molecular diagnostic tests and instruments for genetic analysis, and Power3, independent validation of test results for both Alzheimer’s and Parkinson’s diseases are being conducted with key clinical centers.
At the AAN meeting, Power3’s Scientific Advisory Board met to plan the next phase of key validation trials. The Scientific Advisory Board currently includes Stanley H. Appel, M.D. Chair of Neurology at Methodist Neurological Research Institute in Houston, Marwan Sabbagh, MD, Medical Director of the Banner Sun Health Research Institute in Sun City, Ariz and principal investigator of the Alzheimer’s study, Bruce Chase, PhD, Neuroscientist and Professor of Biology at the University of Nebraska, Omaha and Dr. Marcopoulou.
"This is the first formal announcement from Transgenomic and Power3 of the clinical introduction of the NuroPro blood test for Alzheimer’s and Parkinson’s Diseases. The presentation of successful Phase I validation of NuroPro for Parkinson’s disease was performed using blood serum from patients, in the same way that the test will be performed in a clinical diagnostic setting.
The statistically significant results achieved in comparing samples from non-diseased age-matched controls to those from mild, moderate, and severe Parkinson’s disease demonstrated the diagnostic capability of NuroPro PD at this prestigious meeting," said Power 3’s President and Chief Scientific Officer, Dr. Ira L. Goldknopf.
"The agreement with Transgenomic, the progress of the clinical validation achieved to date and the introduction at the AAN meeting are steps toward our goal to be the first to market with clinically relevant diagnostic tests for Alzheimer’s and Parkinson’s diseases," commented Helen R. Park, CEO of Power3.
Craig Tuttle, President and CEO of Transgenomic, added: "We are excited to see this first key clinical validation milestone for the NuroPro PD assay in Parkinson’s disease announced at a major neurology conference. The observation that we may be able to quantify disease severity may prove instrumental in allowing better therapy selections, as well as having therapy initiated more quickly. We remain committed to launching these assays in our CLIA-certified reference lab before the end of the year."
Source: Transgenomic Inc and Power3 Medical Products Inc