Problem

Peripheral neuropathy, especially small fiber neuropathy, is a debilitating condition that affects millions and is commonly linked to aging, diabetes, and metabolic disorders. Existing diagnostic tools are often invasive, expensive, or they lack the sensitivity to detect early disease stages, while current treatment options tend to be generalized and limited in effectiveness. There is a critical need for a reliable biomarker that can accurately track disease progression and support personalized therapeutic approaches

Solution

• Researchers at OSU have developed a diagnostic and therapeutic platform kit for the detection of post-synaptic density protein-95 (PSD-95) in skin, adipose tissue, or interstitial fluid samples. The kit includes tools for detecting PSD-95 levels in biological samples using ELISA, PCR, or immunostaining methods
• As changes in PSD-95 levels correlate with synaptic density and nerve health, the platform enables informed therapeutic decision-making and early intervention. Treatment options may include gene therapy, neuromodulation, new pharmacotherapeutics in clinical trials, modification of diabetes treatments, or lifestyle modifications. Following treatment, PSD-95 levels can be re-measured to assess therapeutic effectiveness, allowing a personalized and adaptive treatment plan

Applications

• Clinical diagnostics: Early detection and monitoring of peripheral neuropathy in aging populations, obese/pre-diabetic/diabetic patients, or other small fiber neuropathies
• Pharmaceutical development: Biomarker-based assessment of drug efficacy in clinical trials for peripheral neuropathy
• Personalized medicine: Guiding individualized treatment plans based on PSD-95 expression levels

Advantages

• Non-invasive sampling: The kit is compatible with skin or adipose tissue biopsies (ex: lipoaspirate) and interstitial fluid, offering flexibility and minimal invasiveness
• High sensitivity and specificity: PSD-95 is a robust and dependable marker of synaptic density and nerve health
• Versatility: The platform supports ELISA, PCR, and immunostaining detection
• Therapeutic guidance: The technology enables monitoring of treatment efficacy and disease progression, allowing for a personalized and adjustable treatment plan
• Affordability: Quantification of PSD-95 levels enables a more rapid and less expensive diagnosis of neuropathy than existing tools such as large fiber functional tests (ex: NCV), restricted nerve function tests (ex: QSART, autonomic sweat gland only), or non-functional histological assessments (ex: IENFD)

Seeking opportunities for co-development or out-licensing