COPD Biomarker Qualification Consortium Partners with Bio-Techne to Identify COPD Indicator
January 10, 2017 |
WASHINGTON, D.C./MINNEAPOLIS, MN - January 11, 2017 -The COPD Foundation-sponsored COPD Biomarker Qualification Consortium (CBQC) today announced that it has partnered with the Bio-Techne Corporation, a manufacturer of biotechnology products for life science research and diagnostics. The partnership was established to evaluate the suitability of a soluble form of receptor for advanced glycation end products (sRAGE) as a predictive biomarker to support subject selection for clinical trials in emphysema. Increasing evidence suggests that serum sRAGE could serve as an indicator of the presence and/or progression of emphysema, a form of chronic obstructive disease (COPD). A validated commercial assay or test for sRAGE does not currently exist. The COPD Foundation, along with its partners in the CBQC and Bio-Techne, will be collaborating with a working group of industry and academic affiliates on the initiative.
“We are honored that the CBQC has chosen Bio-Techne as their development partner for this important test,” said Charles R. Kummeth, President and Chief Executive Officer of Bio-Techne. “We have a long history of innovation with different immunoassay technologies and biomarkers that can be applied here to ultimately help improve outcomes for emphysema patients.”
Since its inception in 2010, the CBQC has selected several important measures to be considered for qualification by the U.S. Food and Drug Administration (FDA) as tools for drug development. The initial measures/biomarkers selected were plasma fibrinogen (a blood biomarker), the St. George’s Respiratory Questionnaire, and the 6-minute walk test (an exercise test). Since serum and plasma sRAGE levels can prospectively identify the subset of patients with COPD at greatest risk for emphysema progression, targeted drug/biologic development and treatments could be optimized by using sRAGE measurements. Several large cohort studies have reported sRAGE to be a strong marker of emphysema, even more so than airflow obstruction.
“The CBQC sRAGE working group is excited to partner with Bio-Techne on the qualification of serum sRAGE as a drug development tool. Bio-Techne is an industry leader in assay development and they bring a tremendous amount of knowledge and expertise to this effort,” stated John Yonchuk, Industry Working Group Co-Chair (GlaxoSmithKline).
Russell Bowler, Director of Program in Precision Medicine at National Jewish Health added, “Their provision of a fully validated bioanalytical assay for use in this qualification is an important part of the process and we look forward to working with them and with regulatory agencies to secure qualification of this new drug development tool.”
The program will proceed in two phases: 1) development of the assay in a small number of samples and 2) evaluation of the selected assay based on the FDA guidance for clinical bioanalytical method validation.
About Bio-Techne: Bio-Techne Corporation (NASDAQ: TECH) is a leading developer and manufacturer of high quality purified proteins––notably cytokines and growth factors, antibodies, immunoassays, as well as biologically active small molecule compounds --- which are sold to biomedical researchers and clinical research laboratories; these operations constitute the core Biotech Division, headquartered in Minneapolis, Minnesota. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. For more information on Bio-Techne and its brands, please visit www.bio-techne.com.