Power3 Medical Products Inc has announced today that results for the early stage diagnosis from clinical validation trials of the NuroPro® PD test for Parkinson’s disease are better than expected.
The NuroPro PD test was developed to help clinicians distinguish patients with Parkinson’s disease from "normal" individuals and patients with other neurological disorders. The NuroPro PD test, developed by Power3, utilizes a panel of blood serum protein biomarkers evaluated by biostatistical analysis to predict the probability that a patient has Parkinson’s disease. The test is intended to solve a critical challenge facing physicians, clinicians, and patients for a quick, early stage and accurate diagnosis of the debilitating disease known as Parkinson’s.
"In the US, there are an estimated 1.5 million individuals with Parkinson’s disease. Presently, annual treatment per patient is $25 thousand for Parkinson’s. Unfortunately, this disease is often misdiagnosed, and may take up to 10 years before the correct diagnosis is rendered. By the time patients are given a probable diagnosis, they have already suffered substantial and irreparable brain damage, rendering treatment less effective, even with existing drugs," said Power3’s President and Chief Scientific Officer, Dr. Ira L. Goldknopf.
The latest results, from the completion of the first phase of clinical validation trials of the NuroPro® PD test, were found in blood serum samples from 52 Parkinson’s disease patients and 28 age matched normal controls from the University of Thessaly, Greece, as well as 6 Parkinson’s disease patients and 50 age matched normal controls from Banner Sun Health Research Institute, Sun City, Arizona.
They not only show a sensitivity of 93.3% for detection of mild, moderate and severe Parkinson’s disease overall, as measured by two separate clinical scoring methods, but also that the sensitivity for early stage Parkinson’s disease patients was 100%. The specificity of the test for correct diagnosis of normal individuals was 96.2%. "The fact that these results were obtained using fresh blood serum from patients, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for the clinical usefulness of these findings," commented Dr. Goldknopf.
Power3 is conducting the independent validation of both their Alzheimer’s (NuroPro AD) and Parkinson’s (NuroPro PD) tests with key clinical centers. The second phase of these prospective trials are being conducted with Katerina Markopoulou, M.D., Assistant Professor of Neurology at the University of Thessaly, Greece, principal investigator for Parkinson’s, and Marwan Sabbagh, M.D., Medical Director of the Banner Sun Health Research Institute in Sun City, AZ, principal investigator of the Alzheimer’s study, and are slated for completion to launch of the Clia testing service in late 2009.
"The progress of the clinical validation achieved to date affirms our belief that NuroPro PD will help physicians make earlier diagnoses and recommend appropriate follow-up and treatment options for their patients," commented Helen R. Park, CEO of Power3.
Source: Power3 Medical Products