Case Studies
Radix BioSolutions Helps Improve Data Quality and Strengthen Study
The Opportunity
A venture-funded biotechnology company, Aviir, Inc. leverages its in-depth understanding of disease marker proteins and advanced biostatistics to develop cutting-edge, diagnostic tests for cardiovascular disease. With an aggressive commercialization strategy, Aviir is expecting to bring its first breakthrough product to market as rapidly as possible.
The Challenge
Aviir is completing a series of studies that involve the profiling and selection of protein biomarkers instrumental in identifying people at risk of cardiovascular disease.
When screening archived clinical sample populations, it is not unusual to encounter some samples that have a very limited volume for some study subjects. The limited sample volume often means that the sample could not be retested in the event of an error. If too many samples are lost due to this problem, the statistical power of the study would be reduced significantly thus delaying discovery and development.
Aviir needed a solution that would allow them to ensure the integrity and accuracy of replicate data obtained for each individual sample, thus increasing the statistical power of the study.
The Solution
Aviir turned to Radix BioSolution's AssayCheX™ panel of control beads. Developed to ensure the integrity and accuracy of xMAP® assay data, AssayCheX allows Aviir to dramatically improve the way they identify errors impacting the results from each individual sample well, flag them as outlier data, and remove just the impacted wells from the study.
Aviir also followed the recommended protocol developed by Radix BioSolutions, to establish optimal threshold values for, and maximize the efficacy of, AssayCheX. Implementing both the protocol and AssayCheX, Aviir also incorporated a module in MasterPlex Software developed by Hitachi Software to rapidly and efficiently assess data quality.
The Results
To confirm the efficiency gains, Aviir tested a number of samples using AssayCheX. The results indicated that, without AssayCheX, it would have been more difficult to recognize outliers to be eliminated from the data. It was also demonstrated that AssayCheX beads do not interfere with the integrity of the assays to measure specific analytes.
By partnering with Radix BioSolutions, Aviir will be able to take the guesswork out of the process, and discover errors before they impact their studies.
Explains Aviir Scientist Ali Vahedi, "Using AssayCheX process control beads leads to enhanced confidence in the data obtained, providing justification for the removal of outliers and improving the robustness of the xMAP assays. Having this capability will be invaluable in situations where sample volume is limited and retests are impossible."
