NEW YORK (GenomeWeb) – The COPD Foundation-sponsored COPD Biomarker Qualification Consortium (CBQC) said today that it has partnered with diagnostics and biotech manufacturer Bio-Techne to evaluate and qualify a serum-based predictive biomarker for selecting subjects for emphysema clinical trials.
The marker, the soluble form of receptor for advanced glycation end products (sRAGE), has shown promise in scientific studies as an indicator of the presence and/or progression of emphysema, the consortium said.
Because no validated commercial assays for sRAGE currently exist, the COPD Foundation, the CBQC, and Bio-Techne now plan to collaborate to develop one. The hope is that serum or plasma sRAGE levels could prospectively identify the subset of patients with COPD who are at greatest risk for emphysema progression, so that they can be enriched in clinical trials for targeted treatments.
Russell Bowler, Director of Program in Precision Medicine at National Jewish Health, said in a statement that Bio-Techne will provide a "fully validated bioanalytical assay" for use in this effort.
First the partners plan to develop the assay in a small number of samples, and then they intend to evaluate it further based on the US Food and Drug Administration's guidance for clinical bioanalytical method validation.