COPD

First COPD biomarker approved by FDA

Tuesday, 14 Jul 2015


The FDA has approved the first COPD biomarker for use in interventional clinical trials.

The blood biomarker plasma fibrinogen can now be used in studies that examine exacerbations and/or all-cause mortality in patients with COPD, the regulatory body said in a statement.

The initial biomarkers selected were plasma fibrinogen, St. George’s Respiratory Questionnaire, and the 6-minute walk test.

“We applaud the FDA for approving plasma fibrinogen as a biomarker and hope to develop a clear path forward on the SGRQ and the 6-minute walk test biomarkers as well,” said the COPD Foundation’s Biomarker Qualification Consortium.  

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