Biomarker Panel Validated for Parkinson's Disease Diagnosis

Fifty-seven protein biomarkers, which had been discovered using retrospective blood serum samples from various neurodegenerative diseases, were then applied specifically to PD samples in a prospective clinical investigation using freshly collected blood serum from PD patients and age-matched normal controls.

When applied to the PD samples, a 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.

The analytic technology that forms the basis for the NuroProPD test for PD being is being commercialized by Transgenomic (Huston, TX, USA) according to a licensing/collaboration agreement with Power3 Medical (Omaha, NE, USA), signed in early 2009. The study represents a significant validation milestone in the clinical development of the NuroProPD diagnostic assay.

Craig Tuttle, CEO of Transgenomic, said, "We are completing the clinical validation of the assay in our [clinical laboratory approved amendments] CLIA-certified molecular testing laboratory and will be launching the assay in the very near future."

Power3 also operates a CLIA certified laboratory and employs sensitive and specific combinations of biomarkers it has discovered from a broad range of diseases as the basis of highly selective blood-based tests for Parkinson's and Alzheimer's diseases, amyotrophic lateral sclerosis, as well as breast cancer.

Related Links:
Transgenomic
Power3 Medical