Serologic test to monitor and treat low turnover renal osteodystrophy

This technology is a serologic test that measures the levels of circulating micro-RNAs (miRNAs) associated with low bone turnover renal osteodystrophy that may be used to monitor disease status guide therapeutic management.

Unmet Need: Non-invasive assessment of bone turnover to treat bone metabolic diseases

Renal osteodystrophy is a highly prevalent bone metabolic disease caused by abnormal rates of bone turnover. Effective treatment requires an accurate assessment of bone turnover and tailored delivery of drugs that reduce or enhance turnover. Currently, the standard of care for estimating bone turnover are bone biopsies that are impractical for many patients, expensive, invasive, and may take months to obtain results.

The Technology: Serum miRNA panel to accurately discriminate low turnover renal osteodystrophy

This assay measures the levels of a subset of miRNAs present in serum that correlate with the rate of bone turnover. Diagnostic accuracy is further bolstered by also monitoring the serum levels of parathyroid hormone (PTH) and Bone-Specific Alkaline Phosphatase (BSAP). Through a simple blood draw, the non-invasive test provides an estimation of aberrant turnover that is significantly more accurate than existing blood biomarkers that presently are insufficient to inform treatment plans. Due to the ease of sampling and rapid output of results, this miRNA panel may be used to effectively monitor disease progression and guide therapeutic management of renal osteodystrophy with vitamin D analogs, calcimimetics and anti-osteoporotic agents.

This technology has been validated in patient cohorts with renal osteodystrophy.

Applications:

• Diagnosing diseases associated with abnormal bone turnover, including osteoporosis, renal osteodystrophy, and Gaucher disease
• Monitoring rate of bone turnover in various diseases
• Guide treatment plan for renal osteodystrophy in chronic kidney disease
• Rapid assessment of patient response to therapeutic intervention

Advantages:

• Non-invasive
• Rapid results
• Cost-effective
• Highly sensitive to dynamic processes associated with disease
• Limits the need for biopsies
• Enables effective monitoring of drug responses

Lead Inventor:

Thomas L. Nickolas, M.D.

Patent Information:

Patent Status

Related Publications:

• Nickolas TL, Chen N, McMahon DJ, Dempster D, Zhou H, Dominguez J, Aponte MA, Sung J, Evenepoel P, D’Haese PC, Mac-Way F, Moyses R, Moe S. “A microRNA Approach to Discriminate Cortical Low Bone Turnover in Renal Osteodystrophy.” JBMR Plus. 2020 Mar 25;4(5):e10353

Tech Ventures Reference:

• IR CU18256

• Licensing Contact: Ron Katz