NeuroMetrix, Inc. (the "Company") (Nasdaq: NURO), a medical device company focused on the treatment and management of the neurological complications of diabetes, today reported publication of results from a study conducted at the University of Toronto. The study by Lee and colleagues titled "Reliability and Validity of a Point-of-Care Sural Nerve Conduction Device for Identification of Diabetic Neuropathy" is available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0086515
NC-stat DPNCheck® is a fast, accurate and quantitative point-of-care test for diabetic peripheral neuropathy, or DPN. The DPNCheck test addresses an unmet medical need for better and more cost-effective screening, diagnosing and monitoring of DPN. This complication affects over 50% of people with diabetes and leads to foot ulcers and limb amputation, as well as severe pain and an overall reduction in patient quality of life.
The study by Lee and colleagues was a single site, blinded comparison of DPNCheck with gold standard laboratory nerve conduction studies. The study enrolled 44 subjects with diabetes. Key reported results include:
Intra-rater reproducibility of 0.94-0.97 (intra-class correlation coefficient)
Inter-rater reproducibility of 0.79-0.83 (intra-class correlation coefficient)
DPNCheck sural nerve amplitude sensitivity of 88% and specificity of 94%
DPNCheck sural nerve conduction velocity sensitivity of 94% and specificity of 82%
Overall DPNCheck test accuracy of 0.88 as quantified by area under the receiver operating characteristic (ROC) curve.
The study authors concluded that DPNCheck could provide valid nerve conduction measures that can be used as a confirmatory test for DSP [DPN] with high reproducibility, acceptable accuracy, and excellent validity."
"The excellent diagnostic performance of DPNCheck, as reported by Lee and colleagues, indicates that it is effective at both detecting and ruling-out DPN. This supports its use for screening as well as conventional diagnostic testing," said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. "Moreover, the study expands the large base of clinical evidence supporting the effectiveness of NC-stat nerve conduction measurement technology."