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NeuroMetrix Press Release Highlights 3 Added DPNCheck Clinical Studies

NeuroMetrix, Inc. (NASDAQ:NURO) today reported the recent publication of three additional DPNCheck clinical studies. DPNCheck is a point-of-care test that provides accurate and cost-effective screening, diagnosis and

Benzinga · 03/05/2020 17:17

NeuroMetrix, Inc. (NASDAQ:NURO) today reported the recent publication of three additional DPNCheck clinical studies. DPNCheck is a point-of-care test that provides accurate and cost-effective screening, diagnosis and monitoring of peripheral neuropathies such as diabetic peripheral neuropathy (DPN).

Automated Measurement of Sural Nerve Conduction is a Useful Screening Tool for Peripheral Neuropathy in Type 1 Diabetes Mellitus. Papanas et al. Rev Diabet Stud. 2019. https://www.ncbi.nlm.nih.gov/pubmed/31509155

The diagnostic accuracy of DPNCheck was assessed in 53 patients with type 1 diabetes with Neuropathy Disability Score (NDS) as the reference method.  The study authors concluded “… the findings of this study suggest that the NC-stat® DPNCheck™ device yields high sensitivity and specificity for the diagnosis of DPN in T1DM … Overall, there appears to be a role for the NC-stat® DPNCheck™ device for more widespread DPN screening in both diabetes types.”

Validity and reliability of a point-of-care nerve conduction device in diabetes patients. Shibata et al. J Diabetes Investig. 2019. https://www.ncbi.nlm.nih.gov/pubmed/30659760

DPNCheck results were compared to traditional nerve conduction studies in 57 patients with diabetes (56 with type 2).  The study authors concluded, “The point-of-care device has excellent reproducibility and good agreement with standard electromyography system. The device might be useful to evaluate diabetic polyneuropathy.”

A PRPH splice-donor variant associates with reduced sural nerve amplitude and risk of peripheral neuropathy. Bjornsdottir et al. Nat Commun. 2019. https://www.ncbi.nlm.nih.gov/pubmed/30992453

DPNCheck was used as the outcome measure in a large genome-wide association study between sural nerve conduction amplitude and velocity in 7045 subjects.  The study demonstrated that individuals with a variant in the PRPH (Peripheren) gene have a higher risk of early-onset axonal polyneuropathy.

“These three recently published studies contribute to the growing body of research that validates the technical and diagnostic accuracy of DPNCheck and adds to its credibility as a primary outcome measure in clinical trials and epidemiological studies,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. “There are now over 30 peer-reviewed publications assessing DPNCheck clinical performance or its use as an objective peripheral neuropathy outcome.”